ABSORB Clinical Investigation, Cohort B

A Clinical Evaluation of the Bioabsorbable Everolimus Eluting Coronary Stent System (BVS EECSS) in the Treatment of Patients With de Novo Native Coronary Artery Lesions.

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00856856

Acronym

ABSORB B

Enrollment

101

Registered

2009-03-06

Start date

2009-03-31

Completion date

2016-03-31

Last updated

2019-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease, Coronary Disease, Coronary Restenosis

Keywords

Bioabsorbable, Coronary Stent, Everolimus, Drug eluting stents, Stents, Angioplasty, Coronary artery disease (CAD), Total coronary occlusion, Coronary artery restenosis, Stent thrombosis, Vascular disease, Myocardial ischemia, Coronary artery stenosis

Brief summary

The purpose of this study is to assess the safety and performance of the BVS Everolimus Eluting Coronary Stent System (EECSS) in the treatment of patients with a maximum of two de novo native coronary artery lesions located in two different major epicardial vessels. Currently in development at Abbott Vascular. Not available for sale in the United States.

Interventions

DEVICEBioabsorbable Everolimus Eluting Coronary Stent

Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

General inclusion criteria 1. Patient must be at least 18 years of age. 2. Patient is able to verbally confirm understanding of risks, benefits and treatment alternatives of receiving the BVS Everolimus Eluting CSS and he/she or his/her legally authorized representative provides written informed consent prior to any Clinical Investigation related procedure, as approved by the appropriate Ethics Committee of the respective clinical site. 3. Patient must have evidence of myocardial ischemia (e.g., stable or unstable angina, silent ischemia, positive functional study or a reversible change in the electrocardiogram (ECG) consistent with ischemia) 4. Patient must be an acceptable candidate for coronary artery bypass graft (CABG) surgery 5. Patient must agree to undergo all clinical investigation plan-required follow-up visits, angiograms, intravascular ultrasound (IVUS), Palpography (optional), optical coherence tomography (OCT) (strongly recommended), multislice computed tomography (MSCT) (optional) and coronary vasomotion (optional) 6. Patient must agree not to participate in any other clinical investigation for a period of two years following the index procedure Angiographic Inclusion Criteria 1. Target lesion(s) must be located in a native coronary artery with visually estimated nominal vessel diameter of 3.0 mm 2. Target lesion(s) must measure ≤ 14 mm in length by visual estimation 3. Target lesion(s) must be in a major artery or branch with a visually estimated stenosis of ≥ 50% and \< 100% with a TIMI flow of ≥ 1 4. If two target lesions meet the inclusion criteria they must be in different major epicardial vessels left anterior descending artery (LAD) with septal and diagonal branches, left circumflex artery (LCX) with obtuse marginal and/or ramus intermedius branches and right coronary artery (RCA) and any of its branches 5. If two target lesion(s) are being treated, each of these lesions must meet all angiographic inclusion/

Exclusion criteria

6. Non-Clinical Investigation, percutaneous intervention for lesions in a non-target vessel is allowed if done ≥ 90 days prior to or if planned to be done 6 months after the index procedure 7. Non-Clinical Investigation percutaneous intervention for lesion in the target vessel is allowed if done \> 6 months prior to or if planned to be done 6 months after the index procedure General

Design outcomes

Primary

Measure	Time frame	Description
Hierarchical Major Adverse Cardiac Event (MACE)	30 days	Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction,and clinically indicated target lesion revascularization (CI-TLR).
In-scaffold Late Loss: In-scaffold MLD Post-procedure - In-scaffold MLD at 1 Year	1 year	In-scaffold Late Loss: in-scaffold MLD post-procedure - in-scaffold MLD at follow-up
In-scaffold Late Loss: In-scaffold MLD Post-procedure - In-scaffold MLD at 180 Days	180 days	In-scaffold Late Loss: in-scaffold MLD post-procedure - in-scaffold MLD at follow-up.

Secondary

Measure	Time frame	Description
In-scaffold Percent Diameter Stenosis (%DS)	180 days	Percent Diameter Stenosis is defined as the value calculated as 100 \* (1 - MLD/RVD) using the mean values from two orthogonal views (when possible) by QCA.
Clinical Device Success (Per Lesion)	On day 0 (the day of procedure)	Successful delivery and deployment of the Clinical Investigation scaffold at the intended target lesion and successful withdrawal of the scaffold delivery system with attainment of final residual stenosis of less than 50% of the target lesion by QCA (by visual estimation if QCA unavailable). Standard pre-dilation catheters and post-dilatation catheters (if applicable) may be used. Bailout patients will be included as device success only if the above criteria for clinical device are met.
Clinical Procedure Success (Per Patient)	On day 0 (the day of procedure)	Successful delivery and deployment of the Clinical Investigation scaffold at the intended target lesion and successful withdrawal of the scaffold delivery system with attainment of final residual stenosis of less than 50% of the target lesion by QCA (by visual estimation if QCA unavailable) and/or using any adjunctive device without the occurrence of ischemia-driven major adverse cardiac event (MACE) during the hospital stay with a maximum of first seven days post index procedure.
Hierarchical Major Adverse Cardiac Event (MACE)	180 days	Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction,and clinically indicated target lesion revascularization (CI-TLR).
Hierarchical Target Vessel Failure (TVF)	30 days	Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).
Ischemia Driven Target Lesion Revascularization (ID-TLR)	30 days	ID-TLR is defined as the revascularization at the target lesion associated with any of the following: * Positive functional ischemia study * Ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA) * Revascularization of a target lesion with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
Ischemia Driven Target Vessel Revascularization (ID-TVR)	30 days	ID-TVR is the revascularization in the target vessel associated with any of the following: * Positive functional ischemia study * Ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA) * Revascularization of a target vessel with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
Cardiac Death	30 days	Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality, cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.)
Aneurysm	180 days	An abnormal expansion or protrusion of a coronary blood vessel resulting from a disease or weakening of the vessel's wall (all three layers) that exceeds the RVD of the vessel by 1.5 times.
Myocardial Infarction	30 days	Myocardial Infarction (MI): * Q wave MI: Development of new, pathological Q wave on the ECG. * Non-Q wave MI: Elevation of Creatine kinase (CK) levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.
Scaffold Thrombosis	30 days	Scaffold thrombosis will be categorized as acute (≤ 1day), subacute (\>1day ≤ 30 days) and late (\>30 days) and will be defined as any of the following: * Clinical presentation of acute coronary syndrome with angiographic evidence of scaffold thrombosis (angiographic appearance of thrombus within or adjacent to a previously treated target lesion) * In the absence of angiography, any unexplained death, or acute MI (ST segment elevation or new Q-wave)\* in the distribution of the target lesion within 30 days \*(Non-specific ST /T changes and cardiac enzyme elevations do not suffice) Any thromboses that occur less than 30 days after the index procedure will not be counted as restenosis.
In-scaffold Late Loss (LL): In-scaffold MLD Post-procedure - In-scaffold MLD at 2 Years	2 years	In-scaffold Late Loss: in-scaffold MLD post-procedure - in-scaffold MLD at follow-up.
In-scaffold Late Loss (LL): In-scaffold MLD Post-procedure - In-scaffold MLD at 3 Years	3 years	In-scaffold Late Loss: in-scaffold MLD post-procedure - in-scaffold MLD at follow-up.
In-scaffold Late Loss (LL): In-scaffold MLD Post-procedure - In-scaffold MLD at 5 Years	5 years	In-scaffold Late Loss: in-scaffold MLD post-procedure - in-scaffold MLD at follow-up.
Proximal Late Loss: Proximal MLD Post-procedure - Proximal MLD at 180 Days	180 days	Proximal Late Loss: proximal MLD post-procedure - proximal MLD at follow-up (proximal defined as within 5 mm of healthy tissue proximal to scaffold placement).
Proximal Late Loss: Proximal MLD Post-procedure - Proximal MLD at 1 Year	1 year	Proximal Late Loss: proximal MLD post-procedure - proximal MLD at follow-up (proximal defined as within 5 mm of healthy tissue proximal to scaffold placement).
Proximal Late Loss: Proximal MLD Post-procedure - Proximal MLD at 2 Years	2 years	Proximal Late Loss: proximal MLD post-procedure - proximal MLD at follow-up (proximal defined as within 5 mm of healthy tissue proximal to scaffold placement).
Proximal Late Loss: Proximal MLD Post-procedure - Proximal MLD at 3 Years	3 years	Proximal Late Loss: proximal MLD post-procedure - proximal MLD at follow-up (proximal defined as within 5 mm of healthy tissue proximal to scaffold placement).
Proximal Late Loss: Proximal MLD Post-procedure - Proximal MLD at 5 Years	5 years	Proximal Late Loss: proximal MLD post-procedure - proximal MLD at follow-up (proximal defined as within 5 mm of healthy tissue proximal to scaffold placement).
Distal Late Loss: Distal MLD Post-procedure - Distal MLD at 180 Days	180 days	Distal Late Loss: distal MLD post-procedure - distal MLD at follow-up (distal defined as within 5 mm of healthy tissue distal to scaffold placement).
Distal Late Loss: Distal MLD Post-procedure - Distal MLD at 1 Year	1 year	Distal Late Loss: distal MLD post-procedure - distal MLD at follow-up (distal defined as within 5 mm of healthy tissue distal to scaffold placement).
Distal Late Loss: Distal MLD Post-procedure - Distal MLD at 2 Years	2 years	Distal Late Loss: distal MLD post-procedure - distal MLD at follow-up (distal defined as within 5 mm of healthy tissue distal to scaffold placement).
Distal Late Loss: Distal MLD Post-procedure - Distal MLD at 3 Years	3 years	Distal Late Loss: distal MLD post-procedure - distal MLD at follow-up (distal defined as within 5 mm of healthy tissue distal to scaffold placement).
Distal Late Loss: Distal MLD Post-procedure - Distal MLD at 5 Years	5 years	Distal Late Loss: distal MLD post-procedure - distal MLD at follow-up (distal defined as within 5 mm of healthy tissue distal to scaffold placement).
In-scaffold Angiographic Binary Restenosis (ABR)	180 days	Percent of patients with a followup percent diameter stenosis of \>=50% per QCA.
Persisting Dissection	180 days	Dissection at follow-up that was present post-procedure.
Thrombus	180 days	—
Vasomotion Analysis: In-scaffold Mean Luminal Diameter	5 years	Vasomotion function was assessed in reaction to nitrate administration.
Volume Obstruction (VO)	180 days	Defined as scaffold intimal hyperplasia and calculated as 100\*(Scaffold Volume - Lumen Volume)/Scaffold Volume by IVUS.
Persisting Incomplete Apposition	180 days	Persisting incomplete apposition is defined as incomplete apposition at follow-up that was present post-procedure. Incomplete Apposition: Failure of the scaffold to completely appose to the vessel wall after placement is defined as one or more scaffold strut separated from the vessel wall with evidence of blood speckles behind the strut in the ultrasound image.
Late Incomplete Apposition	180 days	Late-Acquired Incomplete Apposition is defined as incomplete apposition of the scaffold at follow-up, which was not present post-procedure. Incomplete Apposition: Failure of the scaffold to completely appose to the vessel wall after placement is defined as one or more scaffold strut separated from the vessel wall with evidence of blood speckles behind the strut in the ultrasound image.

Other

Measure	Time frame	Description
Mean Reference Area	1 year	—
Minimum Luminal Area	1 year	—
Mean Luminal Area	1 year	—
Mean Scaffold Area	2 years	—
Minimum Stent Area	1 year	—
Minimum Scaffold Area	2 year	—
Luminal Volume	1 year	—
Stent Volume	1 year	—
Scaffold Volume	2 years	—
Mean Luminal Diameter	1 year	—
Minimum Luminal Diameter (MLD)	1 year	The average of two orthogonal views (when possible) of the narrowest point within the area of assessment - in lesion, in scaffold or in segment. MLD is visually estimated during angiography by the Investigator; it is measured during QCA by the Angiographic Core Lab.
Minimum Luminal Diameter	2 years	The average of two orthogonal views (when possible) of the narrowest point within the area of assessment - in lesion, in scaffold or in segment. MLD is visually estimated during angiography by the Investigator; it is measured during QCA by the Angiographic Core Lab.
Mean Stent Diameter	1 year	—
Mean Scaffold Diameter	2 years	—
Minimum Stent Diameter	1 year	—
Minimum Scaffold Diameter	2 years	—
Strut Volume	1 year	—
Number of Struts Per BVS	1 year	—
% of Covered Struts (150 µm)	1 year	—
% of Acutely Covered Struts	2 years	—
% of Uncovered Struts (150 µm)	1 year	—
Number of Struts in Side Branch	1 year	—
Tissue Coverage Area Classical	1 year	—
Tissue Coverage Area BVS (Neointimal Area)	1 year	—
Tissue Coverage Volume Classical	1 year	—
Tissue Coverage Volume BVS	1 year	—
Tissue Coverage Obstruction Volume Classical	1 year	—
Tissue Coverage Obstruction Volume BVS	1 year	—
Mean Flow Area	1 year	—
Minimum Flow Area	1 year	—
Mean Strut Core Area	1 year	—
Percent (%) Lumen Area Stenosis	1 year	—
Mean Stent Area	1 year	—

Countries

Australia, Belgium, Denmark, France, Netherlands, New Zealand, Poland, Switzerland

Participant flow

Recruitment details

Total of 101 patients (intent to treat patient population \[ITT\]) were enrolled in the ABSORB Cohort B study at 12 clinical sites in Europe/Australia/New Zealand between March 19, 2009 and November 6, 2009. Only for assessing imaging outcomes at different follow-up periods, subjects were divided into Group 1 (n = 45) & Group 2 (n = 56).

Pre-assignment details

ITT population were assessed for all clinical endpoints. For imaging outcomes,Group 1 (n=45) patients were followed up at 180 days, 2 & 5 years; while Group 2 (n=56) patients at 1, 3 & 5 years. Therefore, data related to imaging outcomes are available only for Group 1 at 180 days, 2 & 5 years timeframe & only for Group 2 at 1, 3 & 5 years timeframe

Participants by arm

Arm	Count
Absorb BVS Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.	101
Total	101

Arm

Count

Absorb BVS

Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.

101

Total

101

Withdrawals & dropouts

Period	Reason	FG000
2-year Clinical Follow-up	Lost to Follow-up	1
4-year Clinical Follow-up	Missed visit	1

Baseline characteristics

Characteristic	Absorb BVS
Age, Continuous	62.3 years
Region of Enrollment Australia	4 participants
Region of Enrollment Belgium	14 participants
Region of Enrollment Denmark	12 participants
Region of Enrollment France	8 participants
Region of Enrollment Netherlands	30 participants
Region of Enrollment New Zealand	14 participants
Region of Enrollment Poland	13 participants
Region of Enrollment Switzerland	6 participants
Sex: Female, Male Female	28 Participants
Sex: Female, Male Male	73 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 101
other Total, other adverse events	58 / 101
serious Total, serious adverse events	56 / 101

Outcome results

Primary

Hierarchical Major Adverse Cardiac Event (MACE)

Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction,and clinically indicated target lesion revascularization (CI-TLR).

Time frame: 1 year

Population: Analysis population includes both Group 1 (n=45) and Group 2 (n=56) patients. Intent-to-treat (ITT) population.

Arm	Measure	Value (NUMBER)
Absorb BVS	Hierarchical Major Adverse Cardiac Event (MACE)	6.9 percentage of participants

Primary

Hierarchical Major Adverse Cardiac Event (MACE)

Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction,and clinically indicated target lesion revascularization (CI-TLR).

Time frame: 30 days

Population: Analysis population includes both Group 1 (n=45) and Group 2 (n=56) patients. Intent-to-treat (ITT) population.

Arm	Measure	Value (NUMBER)
Absorb BVS	Hierarchical Major Adverse Cardiac Event (MACE)	2.0 percentage of participants

Primary

In-scaffold Late Loss: In-scaffold MLD Post-procedure - In-scaffold MLD at 180 Days

In-scaffold Late Loss: in-scaffold MLD post-procedure - in-scaffold MLD at follow-up.

Time frame: 180 days

Population: In Cohort B, Group 1. Intent-to-treat (ITT) population. The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
Absorb BVS	In-scaffold Late Loss: In-scaffold MLD Post-procedure - In-scaffold MLD at 180 Days	0.19 Millimeter	Standard Deviation 0.18

Primary

In-scaffold Late Loss: In-scaffold MLD Post-procedure - In-scaffold MLD at 1 Year

In-scaffold Late Loss: in-scaffold MLD post-procedure - in-scaffold MLD at follow-up

Time frame: 1 year

Population: In Cohort B, Group 2. Intent-to-treat (ITT) population. The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
Absorb BVS	In-scaffold Late Loss: In-scaffold MLD Post-procedure - In-scaffold MLD at 1 Year	0.27 Millimeter	Standard Deviation 0.32

Secondary

Aneurysm

An abnormal expansion or protrusion of a coronary blood vessel resulting from a disease or weakening of the vessel's wall (all three layers) that exceeds the RVD of the vessel by 1.5 times.

Time frame: 1 year

Population: Intent-to-treat (ITT) population. Cohort B, Group 2. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm	Measure	Value (NUMBER)
Absorb BVS	Aneurysm	0.0 Percentage of participants

Secondary

Aneurysm

An abnormal expansion or protrusion of a coronary blood vessel resulting from a disease or weakening of the vessel's wall (all three layers) that exceeds the RVD of the vessel by 1.5 times.

Time frame: 5 years

Population: Intent-to-treat (ITT) population.Cohort B, Group 1 and Group 2. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm	Measure	Value (NUMBER)
Absorb BVS	Aneurysm	0.0 Percentage of participants

Secondary

Aneurysm

An abnormal expansion or protrusion of a coronary blood vessel resulting from a disease or weakening of the vessel's wall (all three layers) that exceeds the RVD of the vessel by 1.5 times.

Time frame: 2 years

Population: Intent-to-treat (ITT) population. Cohort B, Group 1. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm	Measure	Value (NUMBER)
Absorb BVS	Aneurysm	2.6 Percentage of participants

Secondary

Aneurysm

An abnormal expansion or protrusion of a coronary blood vessel resulting from a disease or weakening of the vessel's wall (all three layers) that exceeds the RVD of the vessel by 1.5 times.

Time frame: 180 days

Population: Intent-to-treat (ITT) population. Cohort B, Group 1. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm	Measure	Value (NUMBER)
Absorb BVS	Aneurysm	2.4 Percentage of participants

Secondary

Aneurysm

An abnormal expansion or protrusion of a coronary blood vessel resulting from a disease or weakening of the vessel's wall (all three layers) that exceeds the RVD of the vessel by 1.5 times.

Time frame: 3 years

Population: Intent-to-treat (ITT) population. Cohort B, Group 2. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm	Measure	Value (NUMBER)
Absorb BVS	Aneurysm	2.08 Percentage of participants

Secondary

Cardiac Death

Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality, cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.)

Time frame: 4 years

Population: Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=43) and Group 2 (n=56) patients. Two patients (Group 1) lost to follow-up at 4-year follow-up period.

Arm	Measure	Value (NUMBER)
Absorb BVS	Cardiac Death	0 percentage of participants

Secondary

Cardiac Death

Time frame: 3 years

Population: Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=44) and Group 2 (n=56) patients. One patient (Group 1) lost to follow-up at 3-year follow-up period.

Arm	Measure	Value (NUMBER)
Absorb BVS	Cardiac Death	0 percentage of participants

Secondary

Cardiac Death

Time frame: 2 years

Population: Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=44) and Group 2 (n=56) patients. One patient (Group 1) lost to follow-up at 2-year follow-up period.

Arm	Measure	Value (NUMBER)
Absorb BVS	Cardiac Death	0 percentage of participants

Secondary

Cardiac Death

Time frame: 1 year

Population: Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=45) and Group 2 (n=56) patients.

Arm	Measure	Value (NUMBER)
Absorb BVS	Cardiac Death	0 percentage of participants

Secondary

Cardiac Death

Time frame: 30 days

Population: Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=45) and Group 2 (n=56) patients.

Arm	Measure	Value (NUMBER)
Absorb BVS	Cardiac Death	0 percentage of participants

Secondary

Cardiac Death

Time frame: 5 years

Population: Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=44) and Group 2 (n=56) patients. One patient from Group 1 population had lost-to-follow-up. Where as,1 patient (Group 1) missed the 4-year follow up but returned for the 5-year follow up.

Arm	Measure	Value (NUMBER)
Absorb BVS	Cardiac Death	0 percentage of participants

Secondary

Clinical Device Success (Per Lesion)

Successful delivery and deployment of the Clinical Investigation scaffold at the intended target lesion and successful withdrawal of the scaffold delivery system with attainment of final residual stenosis of less than 50% of the target lesion by QCA (by visual estimation if QCA unavailable). Standard pre-dilation catheters and post-dilatation catheters (if applicable) may be used. Bailout patients will be included as device success only if the above criteria for clinical device are met.

Time frame: On day 0 (the day of procedure)

Population: Analysis population includes both Group 1 (n=45) and Group 2 (n=56) patients. Intent-to-treat (ITT) population.

Arm	Measure	Value (NUMBER)
Absorb BVS	Clinical Device Success (Per Lesion)	100.0 percentage of lesions

Secondary

Clinical Procedure Success (Per Patient)

Successful delivery and deployment of the Clinical Investigation scaffold at the intended target lesion and successful withdrawal of the scaffold delivery system with attainment of final residual stenosis of less than 50% of the target lesion by QCA (by visual estimation if QCA unavailable) and/or using any adjunctive device without the occurrence of ischemia-driven major adverse cardiac event (MACE) during the hospital stay with a maximum of first seven days post index procedure.

Time frame: On day 0 (the day of procedure)

Population: Analysis population includes both Group 1 (n=45) and Group 2 (n=56) patients. Intent-to-treat (ITT) population.

Arm	Measure	Value (NUMBER)
Absorb BVS	Clinical Procedure Success (Per Patient)	98.0 percentage of participants

Secondary

Distal Late Loss: Distal MLD Post-procedure - Distal MLD at 180 Days

Distal Late Loss: distal MLD post-procedure - distal MLD at follow-up (distal defined as within 5 mm of healthy tissue distal to scaffold placement).

Time frame: 180 days

Population: Intent-to-treat (ITT) population. Cohort B, Group 1. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
Absorb BVS	Distal Late Loss: Distal MLD Post-procedure - Distal MLD at 180 Days	0.07 Millimeter	Standard Deviation 0.3

Secondary

Distal Late Loss: Distal MLD Post-procedure - Distal MLD at 1 Year

Distal Late Loss: distal MLD post-procedure - distal MLD at follow-up (distal defined as within 5 mm of healthy tissue distal to scaffold placement).

Time frame: 1 year

Population: Intent-to-treat (ITT) population. Cohort B, Group 2. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
Absorb BVS	Distal Late Loss: Distal MLD Post-procedure - Distal MLD at 1 Year	0.07 Millimeter	Standard Deviation 0.27

Secondary

Distal Late Loss: Distal MLD Post-procedure - Distal MLD at 2 Years

Distal Late Loss: distal MLD post-procedure - distal MLD at follow-up (distal defined as within 5 mm of healthy tissue distal to scaffold placement).

Time frame: 2 years

Population: Intent-to-treat (ITT) population. Cohort B, Group 1. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
Absorb BVS	Distal Late Loss: Distal MLD Post-procedure - Distal MLD at 2 Years	0.04 Millimeter	Standard Deviation 0.25

Secondary

Distal Late Loss: Distal MLD Post-procedure - Distal MLD at 3 Years

Distal Late Loss: distal MLD post-procedure - distal MLD at follow-up (distal defined as within 5 mm of healthy tissue distal to scaffold placement).

Time frame: 3 years

Population: Intent-to-treat (ITT) population. Cohort B, Group 2. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
Absorb BVS	Distal Late Loss: Distal MLD Post-procedure - Distal MLD at 3 Years	0.08 Millimeter	Standard Deviation 0.37

Secondary

Distal Late Loss: Distal MLD Post-procedure - Distal MLD at 5 Years

Distal Late Loss: distal MLD post-procedure - distal MLD at follow-up (distal defined as within 5 mm of healthy tissue distal to scaffold placement).

Time frame: 5 years

Population: Intent-to-treat (ITT) population. Cohort B, Group 1 and Group 2. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
Absorb BVS	Distal Late Loss: Distal MLD Post-procedure - Distal MLD at 5 Years	0.11 Millimeter	Standard Deviation 0.35

Secondary

Hierarchical Major Adverse Cardiac Event (MACE)

Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction,and clinically indicated target lesion revascularization (CI-TLR).

Time frame: 2 years

Population: Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=44) and Group 2 (n=56) patients. One patient (Group 1) lost to follow-up at 2-year follow-up period.

Arm	Measure	Value (NUMBER)
Absorb BVS	Hierarchical Major Adverse Cardiac Event (MACE)	9.0 percentage of participants

Secondary

Hierarchical Major Adverse Cardiac Event (MACE)

Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction,and clinically indicated target lesion revascularization (CI-TLR).

Time frame: 180 days

Population: Analysis population includes both Group 1 (n=45) and Group 2 (n=56) patients. Intent-to-treat (ITT) population.

Arm	Measure	Value (NUMBER)
Absorb BVS	Hierarchical Major Adverse Cardiac Event (MACE)	5.0 percentage of participants

Secondary

Hierarchical Major Adverse Cardiac Event (MACE)

Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction,and clinically indicated target lesion revascularization (CI-TLR).

Time frame: 270 days

Population: Analysis population includes both Group 1 (n=45) and Group 2 (n=56) patients. Intent-to-treat (ITT) population.

Arm	Measure	Value (NUMBER)
Absorb BVS	Hierarchical Major Adverse Cardiac Event (MACE)	5.0 percentage of participants

Secondary

Hierarchical Major Adverse Cardiac Event (MACE)

Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction,and clinically indicated target lesion revascularization (CI-TLR).

Time frame: 3 years

Population: Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=44) and Group 2 (n=56) patients. One patient (Group 1) lost to follow-up at 3-year follow-up period.

Arm	Measure	Value (NUMBER)
Absorb BVS	Hierarchical Major Adverse Cardiac Event (MACE)	10.0 percentage of participants

Secondary

Hierarchical Major Adverse Cardiac Event (MACE)

Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction,and clinically indicated target lesion revascularization (CI-TLR).

Time frame: 4 years

Population: Analysis population includes both Group 1 (n=43) and Group 2 (n=56) patients. Two patients (Group 1) lost to follow-up at 4-year follow-up period. Intent-to-treat (ITT) population.

Arm	Measure	Value (NUMBER)
Absorb BVS	Hierarchical Major Adverse Cardiac Event (MACE)	10.1 percentage of participants

Secondary

Hierarchical Major Adverse Cardiac Event (MACE)

Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction,and clinically indicated target lesion revascularization (CI-TLR).

Time frame: 5 years

Population: Analysis population includes both Group 1 (n=44) and Group 2 (n=56) patients. One patient from Group 1 population had lost-to-follow-up. Where as,1 patient (Group 1) missed the 4-year follow up but returned for the 5-year follow up. Intent-to-treat (ITT) population.

Arm	Measure	Value (NUMBER)
Absorb BVS	Hierarchical Major Adverse Cardiac Event (MACE)	11.0 percentage of participants

Secondary

Hierarchical Target Vessel Failure (TVF)

Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).

Time frame: 270 days

Population: Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=45) and Group 2 (n=56) patients.

Arm	Measure	Value (NUMBER)
Absorb BVS	Hierarchical Target Vessel Failure (TVF)	5.0 Percentage of participants

Secondary

Hierarchical Target Vessel Failure (TVF)

Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).

Time frame: 1 year

Population: Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=45) and Group 2 (n=56) patients.

Arm	Measure	Value (NUMBER)
Absorb BVS	Hierarchical Target Vessel Failure (TVF)	6.9 percentage of participants

Secondary

Hierarchical Target Vessel Failure (TVF)

Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).

Time frame: 2 years

Population: Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=44) and Group 2 (n=56) patients. One patient (Group 1) lost to follow-up at 2-year follow-up period.

Arm	Measure	Value (NUMBER)
Absorb BVS	Hierarchical Target Vessel Failure (TVF)	11.0 percentage of participants

Secondary

Hierarchical Target Vessel Failure (TVF)

Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).

Time frame: 3 years

Population: Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=44) and Group 2 (n=56) patients. One patient (Group 1) lost to follow-up at 3-year follow-up period.

Arm	Measure	Value (NUMBER)
Absorb BVS	Hierarchical Target Vessel Failure (TVF)	13.0 percentage of participants

Secondary

Hierarchical Target Vessel Failure (TVF)

Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).

Time frame: 4 years

Population: Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=43) and Group 2 (n=56) patients. Two patients (Group 1) lost to follow-up at 4-year follow-up period.

Arm	Measure	Value (NUMBER)
Absorb BVS	Hierarchical Target Vessel Failure (TVF)	13.1 percentage of participants

Secondary

Hierarchical Target Vessel Failure (TVF)

Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).

Time frame: 5 years

Arm	Measure	Value (NUMBER)
Absorb BVS	Hierarchical Target Vessel Failure (TVF)	14.0 percentage of participants

Secondary

Hierarchical Target Vessel Failure (TVF)

Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).

Time frame: 30 days

Population: Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=45) and Group 2 (n=56) patients.

Arm	Measure	Value (NUMBER)
Absorb BVS	Hierarchical Target Vessel Failure (TVF)	2.0 percentage of participants

Secondary

Hierarchical Target Vessel Failure (TVF)

Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).

Time frame: 180 days

Population: Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=45) and Group 2 (n=56) patients.

Arm	Measure	Value (NUMBER)
Absorb BVS	Hierarchical Target Vessel Failure (TVF)	5.0 Percentage of participants

Secondary

In-scaffold Angiographic Binary Restenosis (ABR)

Percent of patients with a followup percent diameter stenosis of \>=50% per QCA.

Time frame: 1 year

Population: Intent-to-treat (ITT) population. Cohort B, Group 2. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm	Measure	Value (NUMBER)
Absorb BVS	In-scaffold Angiographic Binary Restenosis (ABR)	3.5 Percentage of participants

Secondary

In-scaffold Angiographic Binary Restenosis (ABR)

Percent of patients with a followup percent diameter stenosis of \>=50% per QCA.

Time frame: 5 years

Population: Intent-to-treat (ITT) population. Cohort B, Group 1 and Group 2. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm	Measure	Value (NUMBER)
Absorb BVS	In-scaffold Angiographic Binary Restenosis (ABR)	7.8 Percentage of participants

Secondary

In-scaffold Angiographic Binary Restenosis (ABR)

Percent of patients with a followup percent diameter stenosis of \>=50% per QCA.

Time frame: 180 days

Population: Intent-to-treat (ITT) population. Cohort B, Group 1. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm	Measure	Value (NUMBER)
Absorb BVS	In-scaffold Angiographic Binary Restenosis (ABR)	0.0 Percentage of participants

Secondary

In-scaffold Angiographic Binary Restenosis (ABR)

Percent of patients with a followup percent diameter stenosis of \>=50% per QCA.

Time frame: 3 years

Population: Intent-to-treat (ITT) population. Cohort B, Group 2. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm	Measure	Value (NUMBER)
Absorb BVS	In-scaffold Angiographic Binary Restenosis (ABR)	7.8 Percentage of participants

Secondary

In-scaffold Angiographic Binary Restenosis (ABR)

Percent of patients with a followup percent diameter stenosis of \>=50% per QCA.

Time frame: 2 years

Population: Intent-to-treat (ITT) population. Cohort B, Group 1. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm	Measure	Value (NUMBER)
Absorb BVS	In-scaffold Angiographic Binary Restenosis (ABR)	0.0 Percentage of participants

Secondary

In-scaffold Late Loss (LL): In-scaffold MLD Post-procedure - In-scaffold MLD at 2 Years

In-scaffold Late Loss: in-scaffold MLD post-procedure - in-scaffold MLD at follow-up.

Time frame: 2 years

Population: ITT population. In Cohort B, Group 1. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
Absorb BVS	In-scaffold Late Loss (LL): In-scaffold MLD Post-procedure - In-scaffold MLD at 2 Years	0.27 Millimeter	Standard Deviation 0.19

Secondary

In-scaffold Late Loss (LL): In-scaffold MLD Post-procedure - In-scaffold MLD at 3 Years

In-scaffold Late Loss: in-scaffold MLD post-procedure - in-scaffold MLD at follow-up.

Time frame: 3 years

Population: Intent-to-treat (ITT) population. In Cohort B, Group 2. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
Absorb BVS	In-scaffold Late Loss (LL): In-scaffold MLD Post-procedure - In-scaffold MLD at 3 Years	0.29 Millimeter	Standard Deviation 0.43

Secondary

In-scaffold Late Loss (LL): In-scaffold MLD Post-procedure - In-scaffold MLD at 5 Years

In-scaffold Late Loss: in-scaffold MLD post-procedure - in-scaffold MLD at follow-up.

Time frame: 5 years

Population: Intent-to-treat (ITT) population. Cohort B, Group 1 and Group 2. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
Absorb BVS	In-scaffold Late Loss (LL): In-scaffold MLD Post-procedure - In-scaffold MLD at 5 Years	0.26 Millimeter	Standard Deviation 0.42

Secondary

In-scaffold Percent Diameter Stenosis (%DS)

Percent Diameter Stenosis is defined as the value calculated as 100 \* (1 - MLD/RVD) using the mean values from two orthogonal views (when possible) by QCA.

Time frame: 1 year

Population: Intent-to-treat (ITT) population. Cohort B, Group 2. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
Absorb BVS	In-scaffold Percent Diameter Stenosis (%DS)	21.35 percentage of diameter stenosis	Standard Deviation 11.18

Secondary

In-scaffold Percent Diameter Stenosis (%DS)

Percent Diameter Stenosis is defined as the value calculated as 100 \* (1 - MLD/RVD) using the mean values from two orthogonal views (when possible) by QCA.

Time frame: 3 years

Population: Intent-to-treat (ITT) population. Cohort B, Group 2. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
Absorb BVS	In-scaffold Percent Diameter Stenosis (%DS)	23.16 percentage of diameter stenosis	Standard Deviation 14.85

Secondary

In-scaffold Percent Diameter Stenosis (%DS)

Percent Diameter Stenosis is defined as the value calculated as 100 \* (1 - MLD/RVD) using the mean values from two orthogonal views (when possible) by QCA.

Time frame: 5 years

Population: Intent-to-treat (ITT) population. Cohort B, Group 1 and Group2. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
Absorb BVS	In-scaffold Percent Diameter Stenosis (%DS)	22.74 percentage of diameter stenosis	Standard Deviation 13.94

Secondary

In-scaffold Percent Diameter Stenosis (%DS)

Percent Diameter Stenosis is defined as the value calculated as 100 \* (1 - MLD/RVD) using the mean values from two orthogonal views (when possible) by QCA.

Time frame: 180 days

Population: Intent-to-treat (ITT) population. Cohort B, Group 1. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
Absorb BVS	In-scaffold Percent Diameter Stenosis (%DS)	19.21 percentage of diameter stenosis	Standard Deviation 7.62

Secondary

In-scaffold Percent Diameter Stenosis (%DS)

Percent Diameter Stenosis is defined as the value calculated as 100 \* (1 - MLD/RVD) using the mean values from two orthogonal views (when possible) by QCA.

Time frame: 2 years

Population: Intent-to-treat (ITT) population. Cohort B, Group 1. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
Absorb BVS	In-scaffold Percent Diameter Stenosis (%DS)	20.94 percentage of diameter stenosis	Standard Deviation 7.63

Secondary

Ischemia Driven Target Lesion Revascularization (ID-TLR)

ID-TLR is defined as the revascularization at the target lesion associated with any of the following: * Positive functional ischemia study * Ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA) * Revascularization of a target lesion with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.

Time frame: 180 days

Population: Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=45) and Group 2 (n=56) patients.

Arm	Measure	Value (NUMBER)
Absorb BVS	Ischemia Driven Target Lesion Revascularization (ID-TLR)	2.0 Percentage of participants

Secondary

Ischemia Driven Target Lesion Revascularization (ID-TLR)

Time frame: 30 days

Population: Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=45) and Group 2 (n=56) patients.

Arm	Measure	Value (NUMBER)
Absorb BVS	Ischemia Driven Target Lesion Revascularization (ID-TLR)	0 percentage of participants

Secondary

Ischemia Driven Target Lesion Revascularization (ID-TLR)

Time frame: 270 days

Population: Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=45) and Group 2 (n=56) patients.

Arm	Measure	Value (NUMBER)
Absorb BVS	Ischemia Driven Target Lesion Revascularization (ID-TLR)	2.0 Percentage of participants

Secondary

Ischemia Driven Target Lesion Revascularization (ID-TLR)

Time frame: 1 year

Population: Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=45) and Group 2 (n=56) patients.

Arm	Measure	Value (NUMBER)
Absorb BVS	Ischemia Driven Target Lesion Revascularization (ID-TLR)	4.0 percentage of participants

Secondary

Ischemia Driven Target Lesion Revascularization (ID-TLR)

Time frame: 2 years

Population: Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=44) and Group 2 (n=56) patients. One patient (Group 1) lost to follow-up at 2-year follow-up period.

Arm	Measure	Value (NUMBER)
Absorb BVS	Ischemia Driven Target Lesion Revascularization (ID-TLR)	6.0 percentage of participants

Secondary

Ischemia Driven Target Lesion Revascularization (ID-TLR)

Time frame: 3 years

Population: Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=44) and Group 2 (n=56) patients. One patient (Group 1) lost to follow-up at 3-year follow-up period.

Arm	Measure	Value (NUMBER)
Absorb BVS	Ischemia Driven Target Lesion Revascularization (ID-TLR)	7.0 percentage of participants

Secondary

Ischemia Driven Target Lesion Revascularization (ID-TLR)

Time frame: 4 years

Population: Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=43) and Group 2 (n=56) patients. Two patients (Group 1) lost to follow-up at 4-year follow-up period.

Arm	Measure	Value (NUMBER)
Absorb BVS	Ischemia Driven Target Lesion Revascularization (ID-TLR)	7.1 percentage of participants

Secondary

Ischemia Driven Target Lesion Revascularization (ID-TLR)

Time frame: 5 years

Arm	Measure	Value (NUMBER)
Absorb BVS	Ischemia Driven Target Lesion Revascularization (ID-TLR)	8.0 percentage of participants

Secondary

Ischemia Driven Target Vessel Revascularization (ID-TVR)

ID-TVR is the revascularization in the target vessel associated with any of the following: * Positive functional ischemia study * Ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA) * Revascularization of a target vessel with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.

Time frame: 3 years

Population: Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=44) and Group 2 (n=56) patients. One patient (Group 1) lost to follow-up at 3-year follow-up period.

Arm	Measure	Value (NUMBER)
Absorb BVS	Ischemia Driven Target Vessel Revascularization (ID-TVR)	10.0 Percentage of participants

Secondary

Ischemia Driven Target Vessel Revascularization (ID-TVR)

Time frame: 4 years

Population: Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=43) and Group 2 (n=56) patients. Two patient (Group 1) lost to follow-up at 4-year follow-up period.

Arm	Measure	Value (NUMBER)
Absorb BVS	Ischemia Driven Target Vessel Revascularization (ID-TVR)	10.0 Percentage of participants

Secondary

Ischemia Driven Target Vessel Revascularization (ID-TVR)

Time frame: 5 years

Arm	Measure	Value (NUMBER)
Absorb BVS	Ischemia Driven Target Vessel Revascularization (ID-TVR)	11.0 Percentage of participants

Secondary

Ischemia Driven Target Vessel Revascularization (ID-TVR)

Time frame: 2 years

Population: Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=44) and Group 2 (n=56) patients. One patient (Group 1) lost to follow-up at 2-year follow-up period.

Arm	Measure	Value (NUMBER)
Absorb BVS	Ischemia Driven Target Vessel Revascularization (ID-TVR)	8.0 Percentage of participants

Secondary

Ischemia Driven Target Vessel Revascularization (ID-TVR)

Time frame: 1 year

Population: Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=45) and Group 2 (n=56) patients.

Arm	Measure	Value (NUMBER)
Absorb BVS	Ischemia Driven Target Vessel Revascularization (ID-TVR)	4.0 Percentage of participants

Secondary

Ischemia Driven Target Vessel Revascularization (ID-TVR)

Time frame: 270 days

Population: Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=45) and Group 2 (n=56) patients.

Arm	Measure	Value (NUMBER)
Absorb BVS	Ischemia Driven Target Vessel Revascularization (ID-TVR)	2.0 Percentage of participants

Secondary

Ischemia Driven Target Vessel Revascularization (ID-TVR)

Time frame: 180 days

Population: Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=45) and Group 2 (n=56) patients.

Arm	Measure	Value (NUMBER)
Absorb BVS	Ischemia Driven Target Vessel Revascularization (ID-TVR)	2.0 Percentage of participants

Secondary

Ischemia Driven Target Vessel Revascularization (ID-TVR)

Time frame: 30 days

Population: Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=45) and Group 2 (n=56) patients.

Arm	Measure	Value (NUMBER)
Absorb BVS	Ischemia Driven Target Vessel Revascularization (ID-TVR)	0.0 Percentage of participants

Secondary

Late Incomplete Apposition

Late-Acquired Incomplete Apposition is defined as incomplete apposition of the scaffold at follow-up, which was not present post-procedure. Incomplete Apposition: Failure of the scaffold to completely appose to the vessel wall after placement is defined as one or more scaffold strut separated from the vessel wall with evidence of blood speckles behind the strut in the ultrasound image.

Time frame: 1 year

Population: Cohort B, Group 2. Intent-to-treat (ITT) population. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm	Measure	Value (NUMBER)
Absorb BVS	Late Incomplete Apposition	3.6 Percentage of participants

Secondary

Late Incomplete Apposition

Time frame: 180 days

Population: Cohort B, Group 1. Intent-to-treat (ITT) population. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm	Measure	Value (NUMBER)
Absorb BVS	Late Incomplete Apposition	7.5 Percentage of participants

Secondary

Late Incomplete Apposition

Time frame: 3 year

Population: Cohort B, Group 2. Intent-to-treat (ITT) population. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm	Measure	Value (NUMBER)
Absorb BVS	Late Incomplete Apposition	7.0 Percentage of participants

Secondary

Late Incomplete Apposition

Time frame: 2 year

Population: Cohort B, Group 1. Intent-to-treat (ITT) population. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm	Measure	Value (NUMBER)
Absorb BVS	Late Incomplete Apposition	2.6 Percentage of participants

Secondary

Myocardial Infarction

Myocardial Infarction (MI): * Q wave MI: Development of new, pathological Q wave on the ECG. * Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.

Time frame: 3 years

Population: Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=44) and Group 2 (n=56) patients. One patient (Group 1) lost to follow-up at 3-year follow-up period.

Arm	Measure	Value (NUMBER)
Absorb BVS	Myocardial Infarction	3.0 percentage of participants

Secondary

Myocardial Infarction

Time frame: 4 years

Population: Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=43) and Group 2 (n=56) patients. Two patients (Group 1) lost to follow-up at 4-year follow-up period.

Arm	Measure	Value (NUMBER)
Absorb BVS	Myocardial Infarction	3.0 percentage of participants

Secondary

Myocardial Infarction

Time frame: 5 years

Arm	Measure	Value (NUMBER)
Absorb BVS	Myocardial Infarction	3.0 percentage of participants

Secondary

Myocardial Infarction

Myocardial Infarction (MI): * Q wave MI: Development of new, pathological Q wave on the ECG. * Non-Q wave MI: Elevation of Creatine kinase (CK) levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.

Time frame: 30 days

Population: Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=45) and Group 2 (n=56) patients.

Arm	Measure	Value (NUMBER)
Absorb BVS	Myocardial Infarction	2.0 percentage of participants

Secondary

Myocardial Infarction

Time frame: 1 year

Population: Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=45) and Group 2 (n=56) patients.

Arm	Measure	Value (NUMBER)
Absorb BVS	Myocardial Infarction	3.0 percentage of participants

Secondary

Myocardial Infarction

Time frame: 2 years

Population: Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=44) and Group 2 (n=56) patients. One patient (Group 1) lost to follow-up at 2-year follow-up period.

Arm	Measure	Value (NUMBER)
Absorb BVS	Myocardial Infarction	3.0 percentage of participants

Secondary

Persisting Dissection

Dissection at follow-up that was present post-procedure.

Time frame: 1 year

Population: ITT population. Cohort B, Group 2. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm	Measure	Value (NUMBER)
Absorb BVS	Persisting Dissection	0.0 Percentage of participants

Secondary

Persisting Dissection

Dissection at follow-up that was present post-procedure.

Time frame: 180 days

Population: ITT population. Cohort B, Group 1. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm	Measure	Value (NUMBER)
Absorb BVS	Persisting Dissection	0.0 Percentage of participants

Secondary

Persisting Dissection

Dissection at follow-up that was present post-procedure.

Time frame: 5 years

Population: ITT population. Cohort B, Group 1 and Group 2. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm	Measure	Value (NUMBER)
Absorb BVS	Persisting Dissection	0.0 Percentage of participants

Secondary

Persisting Dissection

Dissection at follow-up that was present post-procedure.

Time frame: 3 years

Population: ITT population. Cohort B, Group 2. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm	Measure	Value (NUMBER)
Absorb BVS	Persisting Dissection	0.0 Percentage of participants

Secondary

Persisting Dissection

Dissection at follow-up that was present post-procedure.

Time frame: 2 years

Population: ITT population. Cohort B, Group 1. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm	Measure	Value (NUMBER)
Absorb BVS	Persisting Dissection	0.0 Percentage of participants

Secondary

Persisting Incomplete Apposition

Persisting incomplete apposition is defined as incomplete apposition at follow-up that was present post-procedure. Incomplete Apposition: Failure of the scaffold to completely appose to the vessel wall after placement is defined as one or more scaffold strut separated from the vessel wall with evidence of blood speckles behind the strut in the ultrasound image.

Time frame: 180 days

Population: Cohort B, Group 1. Intent-to-treat (ITT) population. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm	Measure	Value (NUMBER)
Absorb BVS	Persisting Incomplete Apposition	2.3 Percentage of participants

Secondary

Persisting Incomplete Apposition

Time frame: 3 year

Population: Cohort B, Group 2. Intent-to-treat (ITT) population. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm	Measure	Value (NUMBER)
Absorb BVS	Persisting Incomplete Apposition	0.0 Percentage of participants

Secondary

Persisting Incomplete Apposition

Time frame: 1 year

Population: Cohort B, Group 2. Intent-to-treat (ITT) population. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm	Measure	Value (NUMBER)
Absorb BVS	Persisting Incomplete Apposition	3.5 Percentage of participants

Secondary

Persisting Incomplete Apposition

Time frame: 2 year

Population: Cohort B, Group 1. Intent-to-treat (ITT) population. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm	Measure	Value (NUMBER)
Absorb BVS	Persisting Incomplete Apposition	0.0 Percentage of participants

Secondary

Proximal Late Loss: Proximal MLD Post-procedure - Proximal MLD at 180 Days

Proximal Late Loss: proximal MLD post-procedure - proximal MLD at follow-up (proximal defined as within 5 mm of healthy tissue proximal to scaffold placement).

Time frame: 180 days

Population: Intent-to-treat (ITT) population. In Cohort B, Group 1. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
Absorb BVS	Proximal Late Loss: Proximal MLD Post-procedure - Proximal MLD at 180 Days	0.07 Millimeter	Standard Deviation 0.27

Secondary

Proximal Late Loss: Proximal MLD Post-procedure - Proximal MLD at 1 Year

Proximal Late Loss: proximal MLD post-procedure - proximal MLD at follow-up (proximal defined as within 5 mm of healthy tissue proximal to scaffold placement).

Time frame: 1 year

Population: Intent-to-treat (ITT) population. In Cohort B, Group 2. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
Absorb BVS	Proximal Late Loss: Proximal MLD Post-procedure - Proximal MLD at 1 Year	0.12 Millimeter	Standard Deviation 0.29

Secondary

Proximal Late Loss: Proximal MLD Post-procedure - Proximal MLD at 2 Years

Proximal Late Loss: proximal MLD post-procedure - proximal MLD at follow-up (proximal defined as within 5 mm of healthy tissue proximal to scaffold placement).

Time frame: 2 years

Population: Intent-to-treat (ITT) population. In Cohort B, Group 1. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
Absorb BVS	Proximal Late Loss: Proximal MLD Post-procedure - Proximal MLD at 2 Years	0.12 Millimeter	Standard Deviation 0.36

Secondary

Proximal Late Loss: Proximal MLD Post-procedure - Proximal MLD at 3 Years

Proximal Late Loss: proximal MLD post-procedure - proximal MLD at follow-up (proximal defined as within 5 mm of healthy tissue proximal to scaffold placement).

Time frame: 3 years

Population: Intent-to-treat (ITT) population. In Cohort B, Group 2. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
Absorb BVS	Proximal Late Loss: Proximal MLD Post-procedure - Proximal MLD at 3 Years	0.14 Millimeter	Standard Deviation 0.31

Secondary

Proximal Late Loss: Proximal MLD Post-procedure - Proximal MLD at 5 Years

Proximal Late Loss: proximal MLD post-procedure - proximal MLD at follow-up (proximal defined as within 5 mm of healthy tissue proximal to scaffold placement).

Time frame: 5 years

Population: Intent-to-treat (ITT) population. In Cohort B, Group 1 and Group 2. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
Absorb BVS	Proximal Late Loss: Proximal MLD Post-procedure - Proximal MLD at 5 Years	0.14 Millimeter	Standard Deviation 0.43

Secondary

Scaffold Thrombosis

Scaffold thrombosis will be categorized as acute (≤ 1day), subacute (\>1day ≤ 30 days) and late (\>30 days) and will be defined as any of the following: * Clinical presentation of acute coronary syndrome with angiographic evidence of scaffold thrombosis (angiographic appearance of thrombus within or adjacent to a previously treated target lesion) * In the absence of angiography, any unexplained death, or acute MI (ST segment elevation or new Q-wave)\* in the distribution of the target lesion within 30 days \*(Non-specific ST /T changes and cardiac enzyme elevations do not suffice) Any thromboses that occur less than 30 days after the index procedure will not be counted as restenosis.

Time frame: 1 year

Population: Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=45) and Group 2 (n=56) patients.

Arm	Measure	Value (NUMBER)
Absorb BVS	Scaffold Thrombosis	0 percentage of participants

Secondary

Scaffold Thrombosis

Time frame: 30 days

Population: Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=45) and Group 2 (n=56) patients.

Arm	Measure	Value (NUMBER)
Absorb BVS	Scaffold Thrombosis	0 percentage of participants

Secondary

Scaffold Thrombosis

Time frame: 2 years

Population: Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=44) and Group 2 (n=56) patients. One patient (Group 1) lost to follow-up at 2-year follow-up period.

Arm	Measure	Value (NUMBER)
Absorb BVS	Scaffold Thrombosis	0 percentage of participants

Secondary

Scaffold Thrombosis

Time frame: 3 years

Population: Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=44) and Group 2 (n=56) patients. One patient (Group 1) lost to follow-up at 3-year follow-up period.

Arm	Measure	Value (NUMBER)
Absorb BVS	Scaffold Thrombosis	0 percentage of participants

Secondary

Scaffold Thrombosis

Time frame: 4 years

Population: Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=43) and Group 2 (n=56) patients. Two patients (Group 1) lost to follow-up at 4-year follow-up period.

Arm	Measure	Value (NUMBER)
Absorb BVS	Scaffold Thrombosis	0 percentage of participants

Secondary

Scaffold Thrombosis

Time frame: 5 years

Arm	Measure	Value (NUMBER)
Absorb BVS	Scaffold Thrombosis	0 percentage of participants

Secondary

Thrombus

Time frame: 1 year

Population: Intent-to-treat (ITT) population. Cohort B, Group 2. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm	Measure	Value (NUMBER)
Absorb BVS	Thrombus	0.0 Percentage of participants

Secondary

Thrombus

Time frame: 180 days

Population: Intent-to-treat (ITT) population. Cohort B, Group 1. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm	Measure	Value (NUMBER)
Absorb BVS	Thrombus	0.0 Percentage of participants

Secondary

Thrombus

Time frame: 5 years

Population: Intent-to-treat (ITT) population. Cohort B, Group 1 and Group 2. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm	Measure	Value (NUMBER)
Absorb BVS	Thrombus	0.0 Percentage of participants

Secondary

Thrombus

Time frame: 3 years

Population: Intent-to-treat (ITT) population. Cohort B, Group 2. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm	Measure	Value (NUMBER)
Absorb BVS	Thrombus	2.08 Percentage of participants

Secondary

Thrombus

Time frame: 2 years

Population: Intent-to-treat (ITT) population.Cohort B, Group 1. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm	Measure	Value (NUMBER)
Absorb BVS	Thrombus	2.6 Percentage of participants

Secondary

Vasomotion Analysis: In-scaffold Mean Luminal Diameter

Vasomotion function was assessed in reaction to nitrate administration.

Time frame: 5 years

Population: Intent-to-treat (ITT) population. The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm	Measure	Group	Value (MEAN)	Dispersion
Absorb BVS	Vasomotion Analysis: In-scaffold Mean Luminal Diameter	Pre-Nitro	2.49 Millimeter	Standard Deviation 0.37
Absorb BVS	Vasomotion Analysis: In-scaffold Mean Luminal Diameter	Post-Nitro	2.56 Millimeter	Standard Deviation 0.35

Secondary

Volume Obstruction (VO)

Defined as scaffold intimal hyperplasia and calculated as 100\*(Scaffold Volume - Lumen Volume)/Scaffold Volume by IVUS.

Time frame: 2 year

Population: Cohort B, Group 1. ITT population; IVUS analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
Absorb BVS	Volume Obstruction (VO)	3.33 percent of scaffold volume	Standard Deviation 3.99

Secondary

Volume Obstruction (VO)

Defined as scaffold intimal hyperplasia and calculated as 100\*(Scaffold Volume - Lumen Volume)/Scaffold Volume by IVUS.

Time frame: 3 year

Population: Cohort B, Group 2. ITT population; IVUS analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
Absorb BVS	Volume Obstruction (VO)	4.19 percent of scaffold volume	Standard Deviation 6.43

Secondary

Volume Obstruction (VO)

Defined as scaffold intimal hyperplasia and calculated as 100\*(Scaffold Volume - Lumen Volume)/Scaffold Volume by IVUS.

Time frame: 180 days

Population: Cohort B, Group 1. ITT population; Intravascular ultrasound (IVUS) analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
Absorb BVS	Volume Obstruction (VO)	1.22 percent of scaffold volume	Standard Deviation 1.99

Secondary

Volume Obstruction (VO)

Defined as scaffold intimal hyperplasia and calculated as 100\*(Scaffold Volume - Lumen Volume)/Scaffold Volume by IVUS.

Time frame: 1 year

Population: Cohort B, Group 2. ITT population; IVUS analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
Absorb BVS	Volume Obstruction (VO)	1.47 percent of scaffold volume	Standard Deviation 3.08

Other Pre-specified

Luminal Volume

Time frame: 2 years

Population: Cohort B Group 1, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
Absorb BVS	Luminal Volume	107.66 mm^3	Standard Deviation 34.79

Other Pre-specified

Luminal Volume

Time frame: 3 years

Population: Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
Absorb BVS	Luminal Volume	103.31 mm^3	Standard Deviation 30.86

Other Pre-specified

Luminal Volume

Time frame: 1 year

Population: Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
Absorb BVS	Luminal Volume	106.33 mm^3	Standard Deviation 31.42

Other Pre-specified

Luminal Volume

Time frame: 5 years

Population: Cohort B Group 1 and Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
Absorb BVS	Luminal Volume	106.36 mm^3	Standard Deviation 32.72

Other Pre-specified

Mean Flow Area

Time frame: 3 years

Population: Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
Absorb BVS	Mean Flow Area	6.06 mm^2	Standard Deviation 1.7

Other Pre-specified

Mean Flow Area

Time frame: 1 year

Population: Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
Absorb BVS	Mean Flow Area	5.90 mm^2	Standard Deviation 1.66

Other Pre-specified

Mean Flow Area

Time frame: 5 years

Population: Cohort B (Group 1 and Group 2), Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
Absorb BVS	Mean Flow Area	6.21 mm^2	Standard Deviation 1.83

Other Pre-specified

Mean Flow Area

Time frame: 2 years

Population: Cohort B Group 1, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
Absorb BVS	Mean Flow Area	6.00 mm^2	Standard Deviation 1.76

Other Pre-specified

Mean Luminal Area

Time frame: 2 years

Population: Cohort B Group 1, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
Absorb BVS	Mean Luminal Area	6.00 mm^2	Standard Deviation 1.76

Other Pre-specified

Mean Luminal Area

Time frame: 1 year

Population: Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
Absorb BVS	Mean Luminal Area	5.92 mm^2	Standard Deviation 1.71

Other Pre-specified

Mean Luminal Area

Time frame: 5 years

Population: Cohort B (Group 1 and Group 2), Intent-to-Treat (ITT) Population.OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
Absorb BVS	Mean Luminal Area	6.22 mm^2	Standard Deviation 1.84

Other Pre-specified

Mean Luminal Area

Time frame: 3 years

Population: Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
Absorb BVS	Mean Luminal Area	6.06 mm^2	Standard Deviation 1.7

Other Pre-specified

Mean Luminal Diameter

Time frame: 3 years

Population: Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
Absorb BVS	Mean Luminal Diameter	2.74 mm	Standard Deviation 0.39

Other Pre-specified

Mean Luminal Diameter

Time frame: 1 year

Population: Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
Absorb BVS	Mean Luminal Diameter	2.71 mm	Standard Deviation 0.39

Other Pre-specified

Mean Luminal Diameter

Time frame: 2 years

Population: Cohort B Group 1, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
Absorb BVS	Mean Luminal Diameter	2.72 mm	Standard Deviation 0.42

Other Pre-specified

Mean Luminal Diameter

It is measured during QCA by the Angiographic Core Lab.

Time frame: 5 years

Population: Cohort B (Group 1 and Group 2), Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
Absorb BVS	Mean Luminal Diameter	2.77 mm	Standard Deviation 0.42

Other Pre-specified

Mean Reference Area

Time frame: 3 years

Population: OCT analysis,Cohort B Group 2, Intent-to-Treat Population. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
Absorb BVS	Mean Reference Area	6.24 mm^2	Standard Deviation 1.78

Other Pre-specified

Mean Reference Area

Time frame: 2 years

Population: OCT analysis,Cohort B Group1 , Intent-to-Treat Population. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
Absorb BVS	Mean Reference Area	6.29 mm^2	Standard Deviation 2.13

Other Pre-specified

Mean Reference Area

Time frame: 5 years

Population: OCT analysis,Cohort B (Group 1 and Group 2), Intent-to-Treat Population. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
Absorb BVS	Mean Reference Area	6.13 mm^2	Standard Deviation 1.96

Other Pre-specified

Mean Reference Area

Time frame: 1 year

Population: Optical coherence tomography (OCT) analysis,Cohort B Group 2, Intent-to-Treat Population. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
Absorb BVS	Mean Reference Area	6.34 mm^2	Standard Deviation 2.3

Other Pre-specified

Mean Scaffold Area

Time frame: 2 years

Population: Cohort B Group 1, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
Absorb BVS	Mean Scaffold Area	8.14 mm^2	Standard Deviation 1.88

Other Pre-specified

Mean Scaffold Area

Time frame: 3 years

Population: Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
Absorb BVS	Mean Scaffold Area	8.50 mm^2	Standard Deviation 1.93

Other Pre-specified

Mean Scaffold Diameter

Time frame: 2 years

Population: Cohort B Group 1, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
Absorb BVS	Mean Scaffold Diameter	3.19 mm	Standard Deviation 0.38

Other Pre-specified

Mean Scaffold Diameter

Time frame: 3 years

Population: Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
Absorb BVS	Mean Scaffold Diameter	3.26 mm	Standard Deviation 0.36

Other Pre-specified

Mean Stent Area

Time frame: 1 year

Population: Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
Absorb BVS	Mean Stent Area	7.42 mm^2	Standard Deviation 1.22

Other Pre-specified

Mean Stent Diameter

Time frame: 1 year

Population: Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
Absorb BVS	Mean Stent Diameter	3.06 mm	Standard Deviation 0.24

Other Pre-specified

Mean Strut Core Area

Time frame: 3 years

Population: Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
Absorb BVS	Mean Strut Core Area	0.19 mm^2	Standard Deviation 0.04

Other Pre-specified

Mean Strut Core Area

Time frame: 2 years

Population: Cohort B Group 1, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
Absorb BVS	Mean Strut Core Area	0.15 mm^2	Standard Deviation 0.02

Other Pre-specified

Mean Strut Core Area

Time frame: 1 year

Population: Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
Absorb BVS	Mean Strut Core Area	0.17 mm^2	Standard Deviation 0.05

Other Pre-specified

Minimum Flow Area

Time frame: 1 year

Population: Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
Absorb BVS	Minimum Flow Area	4.28 mm^2	Standard Deviation 1.39

Other Pre-specified

Minimum Flow Area

Time frame: 3 years

Population: Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
Absorb BVS	Minimum Flow Area	4.45 mm^2	Standard Deviation 1.55

Other Pre-specified

Minimum Flow Area

Time frame: 2 years

Population: Cohort B Group 1, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
Absorb BVS	Minimum Flow Area	4.29 mm^2	Standard Deviation 1.47

Other Pre-specified

Minimum Flow Area

Time frame: 5 years

Population: Cohort B (Group 1 and Group 2), Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
Absorb BVS	Minimum Flow Area	4.15 mm^2	Standard Deviation 1.69

Other Pre-specified

Minimum Luminal Area

Time frame: 2 years

Population: Cohort B Group 1, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
Absorb BVS	Minimum Luminal Area	4.29 mm^2	Standard Deviation 1.48

Other Pre-specified

Minimum Luminal Area

Time frame: 5 years

Population: Cohort B (Group 1 and Group 2), Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
Absorb BVS	Minimum Luminal Area	4.15 mm^2	Standard Deviation 1.69

Other Pre-specified

Minimum Luminal Area

Time frame: 1 year

Population: Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
Absorb BVS	Minimum Luminal Area	4.29 mm^2	Standard Deviation 1.39

Other Pre-specified

Minimum Luminal Area

Time frame: 3 years

Population: Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
Absorb BVS	Minimum Luminal Area	4.45 mm^2	Standard Deviation 1.55

Other Pre-specified

Minimum Luminal Diameter

The average of two orthogonal views (when possible) of the narrowest point within the area of assessment - in lesion, in scaffold or in segment. MLD is visually estimated during angiography by the Investigator; it is measured during QCA by the Angiographic Core Lab.

Time frame: 3 years

Population: Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
Absorb BVS	Minimum Luminal Diameter	2.34 mm	Standard Deviation 0.46

Other Pre-specified

Minimum Luminal Diameter

Time frame: 2 years

Population: Cohort B Group 1 , Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
Absorb BVS	Minimum Luminal Diameter	2.30 mm	Standard Deviation 0.4

Other Pre-specified

Minimum Luminal Diameter

Time frame: 5 years

Population: Cohort B (Group1 and Group 2), Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
Absorb BVS	Minimum Luminal Diameter	2.25 mm	Standard Deviation 0.49

Other Pre-specified

Minimum Luminal Diameter (MLD)

Time frame: 1 year

Population: Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
Absorb BVS	Minimum Luminal Diameter (MLD)	2.30 mm	Standard Deviation 0.42

Other Pre-specified

Minimum Scaffold Area

Time frame: 3 years

Population: Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
Absorb BVS	Minimum Scaffold Area	6.66 mm^2	Standard Deviation 1.67

Other Pre-specified

Minimum Scaffold Area

Time frame: 2 year

Population: Cohort B Group 1, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
Absorb BVS	Minimum Scaffold Area	6.33 mm^2	Standard Deviation 1.45

Other Pre-specified

Minimum Scaffold Diameter

Time frame: 3 years

Population: Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
Absorb BVS	Minimum Scaffold Diameter	2.89 mm	Standard Deviation 0.37

Other Pre-specified

Minimum Scaffold Diameter

Time frame: 2 years

Population: Cohort B Group 1, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
Absorb BVS	Minimum Scaffold Diameter	2.82 mm	Standard Deviation 0.33

Other Pre-specified

Minimum Stent Area

Time frame: 1 year

Population: Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
Absorb BVS	Minimum Stent Area	5.96 mm^2	Standard Deviation 1.14

Other Pre-specified

Minimum Stent Diameter

Time frame: 1 year

Population: Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
Absorb BVS	Minimum Stent Diameter	2.74 mm	Standard Deviation 0.26

Other Pre-specified

Number of Struts in Side Branch

Time frame: 5 years

Population: Cohort B (Group 1 and Group 2), Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
Absorb BVS	Number of Struts in Side Branch	0.0 Number of struts	Standard Deviation 0.3

Other Pre-specified

Number of Struts in Side Branch

Time frame: 3 years

Population: Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
Absorb BVS	Number of Struts in Side Branch	0.2 Number of struts	Standard Deviation 0.4

Other Pre-specified

Number of Struts in Side Branch

Time frame: 2 years

Population: Cohort B Group 1, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
Absorb BVS	Number of Struts in Side Branch	0.2 Number of struts	Standard Deviation 0.6

Other Pre-specified

Number of Struts in Side Branch

Time frame: 1 year

Population: Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
Absorb BVS	Number of Struts in Side Branch	0.1 Number of struts	Standard Deviation 0.4

Other Pre-specified

Number of Struts Per BVS

Time frame: 1 year

Population: Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
Absorb BVS	Number of Struts Per BVS	162.1 Number of Struts	Standard Deviation 31.9

Other Pre-specified

Number of Struts Per BVS

Time frame: 2 years

Population: Cohort B Group 1, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
Absorb BVS	Number of Struts Per BVS	160.9 Number of Struts	Standard Deviation 27.9

Other Pre-specified

Number of Struts Per BVS

Time frame: 3 years

Population: Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
Absorb BVS	Number of Struts Per BVS	145.2 Number of Struts	Standard Deviation 32.3

Other Pre-specified

Number of Struts Per BVS

Time frame: 5 years

Population: Cohort B (Group 1 and Group 2), Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
Absorb BVS	Number of Struts Per BVS	7.1 Number of Struts	Standard Deviation 29.1

Other Pre-specified

% of Acutely Covered Struts

Time frame: 2 years

Population: Cohort B Group 1, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
Absorb BVS	% of Acutely Covered Struts	98.07 Percent of Covered Struts	Standard Deviation 3.27

Other Pre-specified

% of Acutely Covered Struts

Time frame: 3 years

Population: Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
Absorb BVS	% of Acutely Covered Struts	97.90 Percent of Covered Struts	Standard Deviation 2

Other Pre-specified

% of Covered Struts (150 µm)

Time frame: 1 year

Population: Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
Absorb BVS	% of Covered Struts (150 µm)	96.86 Percent of Covered Struts	Standard Deviation 2.95

Other Pre-specified

% of Uncovered Struts (150 µm)

Time frame: 3 years

Population: Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
Absorb BVS	% of Uncovered Struts (150 µm)	2.10 Percent of Uncovered Struts	Standard Deviation 2

Other Pre-specified

% of Uncovered Struts (150 µm)

Time frame: 2 years

Population: Cohort B Group 1, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
Absorb BVS	% of Uncovered Struts (150 µm)	1.93 Percent of Uncovered Struts	Standard Deviation 3.27

Other Pre-specified

% of Uncovered Struts (150 µm)

Time frame: 1 year

Population: Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
Absorb BVS	% of Uncovered Struts (150 µm)	3.14 Percent of Uncovered Struts	Standard Deviation 2.95

Other Pre-specified

Percent (%) Lumen Area Stenosis

Time frame: 3 years

Population: Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
Absorb BVS	Percent (%) Lumen Area Stenosis	28.01 Percentage of Lumen Area Stenosis	Standard Deviation 13.68

Other Pre-specified

Percent (%) Lumen Area Stenosis

Time frame: 5 years

Population: Cohort B (Group 1 and Group 2), Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
Absorb BVS	Percent (%) Lumen Area Stenosis	34.32 Percentage of Lumen Area Stenosis	Standard Deviation 16.21

Other Pre-specified

Percent (%) Lumen Area Stenosis

Time frame: 1 year

Population: Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
Absorb BVS	Percent (%) Lumen Area Stenosis	28.70 Percentage of Lumen Area Stenosis	Standard Deviation 12.05

Other Pre-specified

Percent (%) Lumen Area Stenosis

Time frame: 2 years

Population: Cohort B Group 1, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
Absorb BVS	Percent (%) Lumen Area Stenosis	28.75 Percentage of Lumen Area Stenosis	Standard Deviation 10.58

Other Pre-specified

Scaffold Volume

Time frame: 3 years

Population: Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
Absorb BVS	Scaffold Volume	145.07 mm^3	Standard Deviation 36.69

Other Pre-specified

Scaffold Volume

Time frame: 2 years

Population: Cohort B Group 1, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
Absorb BVS	Scaffold Volume	145.78 mm^3	Standard Deviation 38.28

Other Pre-specified

Stent Volume

Time frame: 1 year

Population: Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
Absorb BVS	Stent Volume	132.90 mm^3	Standard Deviation 21.64

Other Pre-specified

Strut Volume

Time frame: 1 year

Population: Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
Absorb BVS	Strut Volume	3.02 mm^3	Standard Deviation 0.66

Other Pre-specified

Strut Volume

Time frame: 2 years

Population: Cohort B Group 1, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
Absorb BVS	Strut Volume	2.61 mm^3	Standard Deviation 0.45

Other Pre-specified

Strut Volume

Time frame: 3 years

Population: Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
Absorb BVS	Strut Volume	3.28 mm^3	Standard Deviation 0.83

Other Pre-specified

Tissue Coverage Area BVS (Neointimal Area)

Time frame: 2 years

Population: Cohort B Group 1, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
Absorb BVS	Tissue Coverage Area BVS (Neointimal Area)	1.99 mm^2	Standard Deviation 0.58

Other Pre-specified

Tissue Coverage Area BVS (Neointimal Area)

Time frame: 3 years

Population: Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
Absorb BVS	Tissue Coverage Area BVS (Neointimal Area)	2.25 mm^2	Standard Deviation 0.6

Other Pre-specified

Tissue Coverage Area BVS (Neointimal Area)

Time frame: 1 year

Population: Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
Absorb BVS	Tissue Coverage Area BVS (Neointimal Area)	1.38 mm^2	Standard Deviation 0.75

Other Pre-specified

Tissue Coverage Area Classical

Time frame: 1 year

Population: Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
Absorb BVS	Tissue Coverage Area Classical	1.54 mm^2	Standard Deviation 0.76

Other Pre-specified

Tissue Coverage Area Classical

Time frame: 3 years

Population: Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
Absorb BVS	Tissue Coverage Area Classical	2.44 mm^2	Standard Deviation 0.61

Other Pre-specified

Tissue Coverage Area Classical

Time frame: 2 years

Population: Cohort B Group 1, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
Absorb BVS	Tissue Coverage Area Classical	2.13 mm^2	Standard Deviation 0.58

Other Pre-specified

Tissue Coverage Obstruction Volume BVS

Time frame: 1 year

Population: Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
Absorb BVS	Tissue Coverage Obstruction Volume BVS	19.40 Percent of Tissue Coverage Obstruction	Standard Deviation 11.52

Other Pre-specified

Tissue Coverage Obstruction Volume BVS

Time frame: 3 years

Population: Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
Absorb BVS	Tissue Coverage Obstruction Volume BVS	27.01 Percent of Tissue Coverage Obstruction	Standard Deviation 7.1

Other Pre-specified

Tissue Coverage Obstruction Volume BVS

Time frame: 2 years

Population: Cohort B Group 1, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
Absorb BVS	Tissue Coverage Obstruction Volume BVS	25.22 Percent of Tissue Coverage Obstruction	Standard Deviation 7.91

Other Pre-specified

Tissue Coverage Obstruction Volume Classical

Time frame: 2 years

Population: Cohort B Group 1, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
Absorb BVS	Tissue Coverage Obstruction Volume Classical	27.10 Percent of Tissue Coverage Obstruction	Standard Deviation 8.16

Other Pre-specified

Tissue Coverage Obstruction Volume Classical

Time frame: 3 years

Population: Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
Absorb BVS	Tissue Coverage Obstruction Volume Classical	29.36 Percent of Tissue Coverage Obstruction	Standard Deviation 7.28

Other Pre-specified

Tissue Coverage Obstruction Volume Classical

Time frame: 1 year

Population: Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
Absorb BVS	Tissue Coverage Obstruction Volume Classical	21.61 Percent of Tissue Coverage Obstruction	Standard Deviation 11.77

Other Pre-specified

Tissue Coverage Volume BVS

Time frame: 3 years

Population: Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
Absorb BVS	Tissue Coverage Volume BVS	38.47 mm^3	Standard Deviation 11.2

Other Pre-specified

Tissue Coverage Volume BVS

Time frame: 1 year

Population: Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
Absorb BVS	Tissue Coverage Volume BVS	24.40 mm^3	Standard Deviation 12.97

Other Pre-specified

Tissue Coverage Volume BVS

Time frame: 2 years

Population: Cohort B Group 1, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
Absorb BVS	Tissue Coverage Volume BVS	35.51 mm^3	Standard Deviation 10.87

Other Pre-specified

Tissue Coverage Volume Classical

Time frame: 2 years

Population: Cohort B Group 1, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
Absorb BVS	Tissue Coverage Volume Classical	38.12 mm^3	Standard Deviation 10.99

Other Pre-specified

Tissue Coverage Volume Classical

Time frame: 3 years

Population: Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
Absorb BVS	Tissue Coverage Volume Classical	41.76 mm^3	Standard Deviation 11.46

Other Pre-specified

Tissue Coverage Volume Classical

Time frame: 1 year

Population: Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
Absorb BVS	Tissue Coverage Volume Classical	27.27 mm^3	Standard Deviation 13.16

Source: ClinicalTrials.gov · Data processed: Mar 31, 2026

ABSORB Clinical Investigation, Cohort B

Conditions

Keywords

Brief summary

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Other

Countries

Participant flow

Recruitment details

Pre-assignment details

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

Hierarchical Major Adverse Cardiac Event (MACE)

Hierarchical Major Adverse Cardiac Event (MACE)

In-scaffold Late Loss: In-scaffold MLD Post-procedure - In-scaffold MLD at 180 Days

In-scaffold Late Loss: In-scaffold MLD Post-procedure - In-scaffold MLD at 1 Year

Aneurysm

Aneurysm

Aneurysm

Aneurysm

Aneurysm

Cardiac Death

Cardiac Death

Cardiac Death

Cardiac Death

Cardiac Death

Cardiac Death

Clinical Device Success (Per Lesion)

Clinical Procedure Success (Per Patient)

Distal Late Loss: Distal MLD Post-procedure - Distal MLD at 180 Days

Distal Late Loss: Distal MLD Post-procedure - Distal MLD at 1 Year

Distal Late Loss: Distal MLD Post-procedure - Distal MLD at 2 Years

Distal Late Loss: Distal MLD Post-procedure - Distal MLD at 3 Years

Distal Late Loss: Distal MLD Post-procedure - Distal MLD at 5 Years

Hierarchical Major Adverse Cardiac Event (MACE)

Hierarchical Major Adverse Cardiac Event (MACE)

Hierarchical Major Adverse Cardiac Event (MACE)

Hierarchical Major Adverse Cardiac Event (MACE)

Hierarchical Major Adverse Cardiac Event (MACE)

Hierarchical Major Adverse Cardiac Event (MACE)

Hierarchical Target Vessel Failure (TVF)

Hierarchical Target Vessel Failure (TVF)

Hierarchical Target Vessel Failure (TVF)

Hierarchical Target Vessel Failure (TVF)

Hierarchical Target Vessel Failure (TVF)

Hierarchical Target Vessel Failure (TVF)

Hierarchical Target Vessel Failure (TVF)

Hierarchical Target Vessel Failure (TVF)

In-scaffold Angiographic Binary Restenosis (ABR)

In-scaffold Angiographic Binary Restenosis (ABR)

In-scaffold Angiographic Binary Restenosis (ABR)

In-scaffold Angiographic Binary Restenosis (ABR)

In-scaffold Angiographic Binary Restenosis (ABR)

In-scaffold Late Loss (LL): In-scaffold MLD Post-procedure - In-scaffold MLD at 2 Years

In-scaffold Late Loss (LL): In-scaffold MLD Post-procedure - In-scaffold MLD at 3 Years

In-scaffold Late Loss (LL): In-scaffold MLD Post-procedure - In-scaffold MLD at 5 Years

In-scaffold Percent Diameter Stenosis (%DS)

In-scaffold Percent Diameter Stenosis (%DS)

In-scaffold Percent Diameter Stenosis (%DS)

In-scaffold Percent Diameter Stenosis (%DS)

In-scaffold Percent Diameter Stenosis (%DS)

Ischemia Driven Target Lesion Revascularization (ID-TLR)

Ischemia Driven Target Lesion Revascularization (ID-TLR)

Ischemia Driven Target Lesion Revascularization (ID-TLR)

Ischemia Driven Target Lesion Revascularization (ID-TLR)

Ischemia Driven Target Lesion Revascularization (ID-TLR)

Ischemia Driven Target Lesion Revascularization (ID-TLR)

Ischemia Driven Target Lesion Revascularization (ID-TLR)