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Absorb GT1 Japan PMS

Absorb GT1 Bioresorbable Vascular Scaffold (BVS) System Post-marketing Surveillance (PMS)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03409731
Enrollment
135
Registered
2018-01-24
Start date
2016-12-13
Completion date
2023-02-06
Last updated
2024-08-06

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

Conditions

Angina Pectoris, Coronary Artery Disease, Coronary Artery Occlusion, Ischemic Heart Disease, Myocardial Ischemia

Keywords

Drug eluting Bio-resolvable Scaffold (BRS), Bio-resolvable Scaffold (BRS), Real world

Brief summary

The purpose of the Surveillance is to know the frequency and status of adverse device effects and adverse events in order to assure the safety of the new medical device, and to collect efficacy and safety information for evaluating clinical use results.

Interventions

DEVICEABSORB GT1 BVS

Patients receiving Absorb GT1 BVS

Sponsors

Abbott Medical Devices
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* General Percutaneous coronary intervention (PCI) population.

Exclusion criteria

* No specific

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants With Acute Scaffold Thrombosis (ST)Day 0Criteria: ST rate (in 2,000 patients : sum of Phase 1 and Phase 2), Success Criteria: ST rate at 3 months is ≤ 18 patients (0.9%). Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation; Subacute scaffold/stent thrombosis: \>24 hours - 30 days post stent implantation; Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation; Very late scaffold/stent thrombosis: \>1 year post stent implantation.
Number of Participants With Sub Acute Scaffold Thrombosis (ST)>1 to 30 daysCriteria: ST rate (in 2,000 patients : sum of Phase 1 and Phase 2), Success Criteria: ST rate at 3 months is ≤ 18 patients (0.9%). Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: \>24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Very late scaffold/stent thrombosis: \>1 year post stent implantation.
Number of Participants With Late Scaffold Thrombosis (ST)31 to 90 daysCriteria: ST rate (in 2,000 patients : sum of Phase 1 and Phase 2),Success Criteria: ST rate at 3 months is ≤ 18 patients (0.9%). Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: \>24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Very late scaffold/stent thrombosis: \>1 year post stent implantation.
Number of Participants With Very Late Scaffold Thrombosis (ST)366 to 730 daysCriteria: ST rate (in 2,000 patients : sum of Phase 1 and Phase 2),Success Criteria: ST rate at 3 months is ≤ 18 patients (0.9%). Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation; Subacute scaffold/stent thrombosis: \>24 hours - 30 days post stent implantation; Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation; Very late scaffold/stent thrombosis: \>1 year post stent implantation.
Number of Participants With Overall Scaffold Thrombosis (ST)0 to 90 daysCriteria: ST rate (in 2,000 patients : sum of Phase 1 and Phase 2),Success Criteria: ST rate at 3 months is ≤ 18 patients (0.9%). Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation; Subacute scaffold/stent thrombosis: \>24 hours - 30 days post stent implantation; Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation; Very late scaffold/stent thrombosis: \>1 year post stent implantation
Number of Participants With Cumulative Scaffold Thrombosis0 to 90 daysCriteria: ST rate (in 2,000 patients : sum of Phase 1 and Phase 2), Success Criteria: ST rate at 3 months is ≤ 18 patients (0.9%). Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: \>24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Very late scaffold/stent thrombosis: \>1 year post stent implantation
Number of Participants With Exclusion of Very Small VesselsDuring index procedure, 54.8 ± 27.6 minFor Phase 1 patients, Angiograms and IVUS/OCT images taken during procedure will be sent immediately to the core lab. Additional training or revision of registration criteria may occur as required in order to exclude almost all lesions with RVD \< 2.5 mm from registration by the last half of Phase 1.
Number of Participants With Scaffold Apposition Assessed by Intravascular ImagingDuring index procedure, 54.8 ± 27.6 minIVUS/OCT images taken during procedure will be sent immediately to the core lab, which will analyze the images and give feedback to the site as required. Images of ST, if occurred, will also be sent to the core lab.
Number of Participants With Composite of Device DeficienciesDuring index procedure, 54.8 ± 27.6 minDevice deficiencies: Number of participants with at least one of the following Device deficiencies 1. Lesion/implant failure 2. Delivery difficulty (finally delivered) 3. Re-crossing failure 4. Re-crossing difficulty 5. Post-dilatation balloon 6. Optical Coherence Tomography (OCT)/Intravascular Ultrasound (IVUS) 7. Instruction for Use (IFU) not included 8. Major Strut Malapposition 9. Strut Fracture within 6 months

Secondary

MeasureTime frameDescription
Number of Participants With Cardiac Death/Myocardial Infarction (MI)0 to 30 daysCardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
Angiographic Endpoints (Core Lab Analysis): Lesion MorphologyPre-procedure
Angiographic Endpoints (Core Lab Analysis):Thrombolysis in Myocardial Infarction (TIMI) Blood FlowPre-procedureTIMI 0 flow (no perfusion) refers to the absence of any antegrade flow beyond a coronary occlusion. TIMI 1 flow (penetration without perfusion) is faint antegrade coronary flow beyond the occlusion, with incomplete filling of the distal coronary bed. TIMI 2 flow (partial reperfusion) is delayed or sluggish antegrade flow with complete filling of the distal territory. TIMI 3 is normal flow which fills the distal coronary bed completely
Angiographic Endpoints (Core Lab Analysis): Lesion LengthPre-procedureLesion Length (can be measured after successful post-dilatation)
Angiographic Endpoints (Core Lab Analysis): Proximal Reference Vessel Diameter (RVD)Pre-procedureProximal RVD (can be measured after successful post-dilatation)
Angiographic Endpoints (Core Lab Analysis): Distal RVDPre-procedureDistal RVD (can be measured after successful post-dilatation)
Angiographic Endpoints (Core Lab Analysis): Minimum Lumen Diameter (MLD)Pre-procedureAngiographic endpoint Minimum lumen diameter is defined as the shortest diameter through the center point of the lumen
Angiographic Endpoints (Core Lab Analysis): Percent Diameter Stenosis (%DS)Pre-procedurePercent Diameter Stenosis is defined as the value calculated as 100 \* (1 - Minimum Luminal Diameter (MLD)/Reference vessel diameter (RVD)) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA).
Number of All Death (Cardiac, Vascular, Non-Cardiovascular)0 to 30 daysCardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
Angiographic Endpoints (Core Lab Analysis): MLD (In-segment)Post-procedure (average procedure time of 54.8 ± 27.6 min)Angiographic endpoint. Minimum lumen diameter is defined as the shortest diameter through the center point of the lumen. In- Segment is defined as, within the margins of the stent or scaffold and 5 mm proximal and 5 mm distal to the stent or scaffold.
Angiographic Endpoints (Core Lab Analysis): %DS (In-Segment )Post-procedure (average procedure time of 54.8 ± 27.6 min)Percent Diameter Stenosis is defined as the value calculated as 100 \* (1 - Minimum Luminal Diameter (MLD)/Reference vessel diameter (RVD)) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA). In- Segment is defined as, within the margins of the stent or scaffold and 5 mm proximal and 5 mm distal to the stent or scaffold.
Angiographic Endpoints (Core Lab Analysis): Acute Gain (In-Segment )Post-procedure (average procedure time of 54.8 ± 27.6 min)The acute gain was defined as the difference between post- and pre procedural minimal lumen diameter (MLD).
IVUS/OCT Endpoints (Core Lab Analysis): Lumen Diameter or Lumen Area (Proximal/Distal)Pre-procedure (or after pre-dilatation)
IVUS/OCT Endpoints (Core Lab Analysis): Minimal Lumen AreaPost-procedure (average procedure time of 54.8 ± 27.6 min)
IVUS/OCT Endpoints (Core Lab Analysis): Percentage of Lesions With Strut MalappositionPost-procedure (average procedure time of 54.8 ± 27.6 min)Percentage of lesions with strut malapposition will be calculated as mean ± standard deviation post-procedure
IVUS/OCT Endpoints (Core Lab Analysis): Percentage of Strut FracturePost-procedure (average procedure time of 54.8 ± 27.6 min)Strut fracture will be measured as either number or percentage post-procedure
Angiographic Endpoints (Core Lab Analysis): Thrombolysis in Myocardial Infarction (TIMI) Blood FlowPost-procedure (average procedure time of 54.8 ± 27.6 min)TIMI 0 flow (no perfusion) refers to the absence of any antegrade flow beyond a coronary occlusion. TIMI 1 flow (penetration without perfusion) is faint antegrade coronary flow beyond the occlusion, with incomplete filling of the distal coronary bed. TIMI 2 flow (partial reperfusion) is delayed or sluggish antegrade flow with complete filling of the distal territory. TIMI 3 is normal flow which fills the distal coronary bed completely
Number of Participants With All Myocardial Infarction (MI)0 to 30 daysMyocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. All myocardial infarction includes target vessel myocardial infarction (TV-MI) and not attributable to target vessel myocardial infarction (NTV-MI)
Number of Participants With All Target Lesion Revascularization (TLR)0 to 30 daysTarget Lesion Revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated \[CI\] or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement. The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent.
Number of Participants With All Target Vessel Revascularization (TVR)0 to 30 daysTarget Vessel Revascularization (TVR) is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.
Number of Participants With All Coronary Revascularization0 to 30 daysAll coronary revascularization is a composite of coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI)
Number of Death/MI/All Revascularization (DMR)0 to 30 daysDMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization
Number of Participants With Target Vessel Failure (TVF)0 to 30 daysTarget Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).
Number of Major Adverse Cardiac Event (MACE)0 to 30 daysMACE is the composite of Cardiac death/All myocardial infarction (MI)/ Ischemia-driven Revascularization (ID-TLR)
Number of Cardiac Death/TV-MI/ID-TLR (TLF)0 to 30 daysTarget Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).

Countries

Japan

Participant flow

Recruitment details

This surveillance planned to consecutively enroll two thousand (2,000) patients. However, in September 2017, Abbott Vascular decided to stop selling the Absorb GT1 system globally, as result of low commercial sales uptake compared to the prediction. Surveillance sites could continue to use the device and register patients until December 15, 2017. As a result, 135 patients were enrolled (treatment with Absorb GT1 attempted, i.e., ITT) by December 11, 2017.

Participants by arm

ArmCount
Absorb GT1 BVS
Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System.
135
Total135

Withdrawals & dropouts

PeriodReasonFG000
Overall StudyDeath4
Overall StudyWithdrawal by Subject17

Baseline characteristics

CharacteristicAbsorb GT1 BVS
Age, Continuous64.0 years
STANDARD_DEVIATION 10.9
Diabetes Mellitus53 Participants
Dyslipidemia84 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
0 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
135 Participants
Hypertension93 Participants
Previous Myocardial Infarction (MI)13 Participants
Prior Coronary Intervention35 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
0 Participants
Race (NIH/OMB)
Black or African American
0 Participants
Race (NIH/OMB)
More than one race
0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
135 Participants
Race (NIH/OMB)
White
0 Participants
Region of Enrollment
Japan
135 participants
Renal Failure5 Participants
Sex: Female, Male
Female
21 Participants
Sex: Female, Male
Male
114 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
4 / 135
other
Total, other adverse events
8 / 135
serious
Total, serious adverse events
43 / 135

Outcome results

Primary

Number of Participants With Acute Scaffold Thrombosis (ST)

Criteria: ST rate (in 2,000 patients : sum of Phase 1 and Phase 2), Success Criteria: ST rate at 3 months is ≤ 18 patients (0.9%). Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation; Subacute scaffold/stent thrombosis: \>24 hours - 30 days post stent implantation; Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation; Very late scaffold/stent thrombosis: \>1 year post stent implantation.

Time frame: Day 0

Population: Full Analysis Set (all participants with Absorb GT1)

ArmMeasureGroupValue (NUMBER)
Absorb GT1 BVSNumber of Participants With Acute Scaffold Thrombosis (ST)Definite0 participants
Absorb GT1 BVSNumber of Participants With Acute Scaffold Thrombosis (ST)Probable0 participants
Absorb GT1 BVSNumber of Participants With Acute Scaffold Thrombosis (ST)Definite/Probable0 participants
Primary

Number of Participants With Composite of Device Deficiencies

Device deficiencies: Number of participants with at least one of the following Device deficiencies 1. Lesion/implant failure 2. Delivery difficulty (finally delivered) 3. Re-crossing failure 4. Re-crossing difficulty 5. Post-dilatation balloon 6. Optical Coherence Tomography (OCT)/Intravascular Ultrasound (IVUS) 7. Instruction for Use (IFU) not included 8. Major Strut Malapposition 9. Strut Fracture within 6 months

Time frame: During index procedure, 54.8 ± 27.6 min

Population: Full Analysis Set (all participants with Absorb GT1)

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Absorb GT1 BVSNumber of Participants With Composite of Device DeficienciesLesion/implant failure0 Participants
Absorb GT1 BVSNumber of Participants With Composite of Device DeficienciesDelivery difficulty (finally delivered)6 Participants
Absorb GT1 BVSNumber of Participants With Composite of Device DeficienciesRe-crossing failure1 Participants
Absorb GT1 BVSNumber of Participants With Composite of Device DeficienciesRe-crossing difficulty0 Participants
Absorb GT1 BVSNumber of Participants With Composite of Device DeficienciesPost-dilatation balloon+OCT/IVUS11 Participants
Absorb GT1 BVSNumber of Participants With Composite of Device DeficienciesIFU not included1 Participants
Absorb GT1 BVSNumber of Participants With Composite of Device DeficienciesMajor Strut Malapposition1 Participants
Absorb GT1 BVSNumber of Participants With Composite of Device DeficienciesStrut Fracture within 6 months1 Participants
Primary

Number of Participants With Cumulative Scaffold Thrombosis

Criteria: ST rate (in 2,000 patients : sum of Phase 1 and Phase 2),Success Criteria: ST rate at 3 months is ≤ 18 patients (0.9%). Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation; Subacute scaffold/stent thrombosis: \>24 hours - 30 days post stent implantation; Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation; Very late scaffold/stent thrombosis: \>1 year post stent implantation

Time frame: 0 - 1460 days

Population: Full Analysis Set (all participants with Absorb GT1)

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Absorb GT1 BVSNumber of Participants With Cumulative Scaffold ThrombosisDefinite0 Participants
Absorb GT1 BVSNumber of Participants With Cumulative Scaffold ThrombosisProbable0 Participants
Absorb GT1 BVSNumber of Participants With Cumulative Scaffold ThrombosisDefinite/Probable0 Participants
Primary

Number of Participants With Cumulative Scaffold Thrombosis

Criteria: ST rate (in 2,000 patients : sum of Phase 1 and Phase 2), Success Criteria: ST rate at 3 months is ≤ 18 patients (0.9%). Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: \>24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Very late scaffold/stent thrombosis: \>1 year post stent implantation

Time frame: 0 to 90 days

Population: Full Analysis Set (all participants with Absorb GT1)

ArmMeasureGroupValue (NUMBER)
Absorb GT1 BVSNumber of Participants With Cumulative Scaffold ThrombosisDefinite0 participants
Absorb GT1 BVSNumber of Participants With Cumulative Scaffold ThrombosisProbable0 participants
Absorb GT1 BVSNumber of Participants With Cumulative Scaffold ThrombosisDefinite/Probable0 participants
Primary

Number of Participants With Cumulative Scaffold Thrombosis

Criteria: ST rate (in 2,000 patients : sum of Phase 1 and Phase 2), Success Criteria: ST rate at 3 months is ≤ 18 patients (0.9%). Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: \>24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Very late scaffold/stent thrombosis: \>1 year post stent implantation

Time frame: 0 to 730 days

Population: The number of participants analyzed includes subjects who had available follow-up data at that time frame. The analysis excludes subjects who are truly lost to follow-up

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Absorb GT1 BVSNumber of Participants With Cumulative Scaffold ThrombosisDefinite0 Participants
Absorb GT1 BVSNumber of Participants With Cumulative Scaffold ThrombosisProbable0 Participants
Absorb GT1 BVSNumber of Participants With Cumulative Scaffold ThrombosisDefinite/Probable0 Participants
Primary

Number of Participants With Cumulative Scaffold Thrombosis

Criteria: ST rate (in 2,000 patients : sum of Phase 1 and Phase 2),Success Criteria: ST rate at 3 months is ≤ 18 patients (0.9%). Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation; Subacute scaffold/stent thrombosis: \>24 hours - 30 days post stent implantation; Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation; Very late scaffold/stent thrombosis: \>1 year post stent implantation

Time frame: 0 - 1095 days

Population: Full Analysis Set (all participants with Absorb GT1)

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Absorb GT1 BVSNumber of Participants With Cumulative Scaffold ThrombosisDefinite0 Participants
Absorb GT1 BVSNumber of Participants With Cumulative Scaffold ThrombosisProbable0 Participants
Absorb GT1 BVSNumber of Participants With Cumulative Scaffold ThrombosisDefinite/Probable0 Participants
Primary

Number of Participants With Cumulative Scaffold Thrombosis

Criteria: ST rate (in 2,000 patients: sum of Phase 1 and Phase2), Success Criteria: ST rate at 3 months is ≤ 18 patients (0.9%). Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis: 0 - 24 hours post stent implantation; Subacute scaffold/stent thrombosis: \>24 hours - 30 days post stent implantation; Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation; Very late scaffold/stent thrombosis: \>1 year post stent implantation.

Time frame: 0 - 1825 days

Population: Full Analysis Set (all participants with Absorb GT1)

ArmMeasureGroupValue (NUMBER)
Absorb GT1 BVSNumber of Participants With Cumulative Scaffold ThrombosisDefinite0 participants
Absorb GT1 BVSNumber of Participants With Cumulative Scaffold ThrombosisProbable0 participants
Absorb GT1 BVSNumber of Participants With Cumulative Scaffold ThrombosisDefinite/Probable0 participants
Primary

Number of Participants With Exclusion of Very Small Vessels

For Phase 1 patients, Angiograms and IVUS/OCT images taken during procedure will be sent immediately to the core lab. Additional training or revision of registration criteria may occur as required in order to exclude almost all lesions with RVD \< 2.5 mm from registration by the last half of Phase 1.

Time frame: During index procedure, 54.8 ± 27.6 min

Population: Full Analysis Set (phase 1 participants with Absorb GT1)

ArmMeasureGroupValue (NUMBER)
Absorb GT1 BVSNumber of Participants With Exclusion of Very Small Vessels< 2.25 mm18 participants
Absorb GT1 BVSNumber of Participants With Exclusion of Very Small Vessels≥ 2.25 mm - < 2.5 mm26 participants
Absorb GT1 BVSNumber of Participants With Exclusion of Very Small Vessels≥ 2.5 mm - ≤ 3.5 mm91 participants
Absorb GT1 BVSNumber of Participants With Exclusion of Very Small Vessels> 3.5 mm4 participants
Primary

Number of Participants With Late Scaffold Thrombosis (ST)

Criteria: ST rate (in 2,000 patients : sum of Phase 1 and Phase 2),Success Criteria: ST rate at 3 months is ≤ 18 patients (0.9%). Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: \>24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Very late scaffold/stent thrombosis: \>1 year post stent implantation.

Time frame: 31 to 90 days

Population: Full Analysis Set (all participants with Absorb GT1)

ArmMeasureGroupValue (NUMBER)
Absorb GT1 BVSNumber of Participants With Late Scaffold Thrombosis (ST)Definite0 participants
Absorb GT1 BVSNumber of Participants With Late Scaffold Thrombosis (ST)Probable0 participants
Absorb GT1 BVSNumber of Participants With Late Scaffold Thrombosis (ST)Definite/Probable0 participants
Primary

Number of Participants With Late Scaffold Thrombosis (ST)

Criteria: ST rate (in 2,000 patients: sum of Phase 1 and Phase2), Success Criteria: ST rate at 3 months is ≤ 18 patients (0.9%). Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis: 0 - 24 hours post stent implantation; Subacute scaffold/stent thrombosis: \>24 hours - 30 days post stent implantation; Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation; Very late scaffold/stent thrombosis: \>1 year post stent implantation.

Time frame: 731 - 1095 days

Population: Full Analysis Set (all participants with Absorb GT1)

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Absorb GT1 BVSNumber of Participants With Late Scaffold Thrombosis (ST)Definite0 Participants
Absorb GT1 BVSNumber of Participants With Late Scaffold Thrombosis (ST)Probable0 Participants
Absorb GT1 BVSNumber of Participants With Late Scaffold Thrombosis (ST)Definite/Probable0 Participants
Primary

Number of Participants With Late Scaffold Thrombosis (ST)

Criteria: ST rate (in 2,000 patients : sum of Phase 1 and Phase 2),Success Criteria: ST rate at 3 months is ≤ 18 patients (0.9%). Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: \>24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Very late scaffold/stent thrombosis: \>1 year post stent implantation.

Time frame: 31 to 365 days

Population: Full Analysis Set (all participants with Absorb GT1)

ArmMeasureGroupValue (NUMBER)
Absorb GT1 BVSNumber of Participants With Late Scaffold Thrombosis (ST)Definite0 participants
Absorb GT1 BVSNumber of Participants With Late Scaffold Thrombosis (ST)Probable0 participants
Absorb GT1 BVSNumber of Participants With Late Scaffold Thrombosis (ST)Definite/Probable0 participants
Primary

Number of Participants With Overall Scaffold Thrombosis (ST)

Criteria: ST rate (in 2,000 patients : sum of Phase 1 and Phase 2),Success Criteria: ST rate at 3 months is ≤ 18 patients (0.9%). Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation; Subacute scaffold/stent thrombosis: \>24 hours - 30 days post stent implantation; Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation; Very late scaffold/stent thrombosis: \>1 year post stent implantation

Time frame: 0 to 90 days

Population: Full Analysis Set (all participants with Absorb GT1)

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Absorb GT1 BVSNumber of Participants With Overall Scaffold Thrombosis (ST)Definite0 Participants
Absorb GT1 BVSNumber of Participants With Overall Scaffold Thrombosis (ST)Probable0 Participants
Absorb GT1 BVSNumber of Participants With Overall Scaffold Thrombosis (ST)Definite/Probable0 Participants
Primary

Number of Participants With Scaffold Apposition Assessed by Intravascular Imaging

IVUS/OCT images taken during procedure will be sent immediately to the core lab, which will analyze the images and give feedback to the site as required. Images of ST, if occurred, will also be sent to the core lab.

Time frame: During index procedure, 54.8 ± 27.6 min

Population: Full Analysis Set (all participants with Absorb GT1)

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Absorb GT1 BVSNumber of Participants With Scaffold Apposition Assessed by Intravascular Imaging5 Participants
Primary

Number of Participants With Sub Acute Scaffold Thrombosis (ST)

Criteria: ST rate (in 2,000 patients : sum of Phase 1 and Phase 2), Success Criteria: ST rate at 3 months is ≤ 18 patients (0.9%). Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: \>24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Very late scaffold/stent thrombosis: \>1 year post stent implantation.

Time frame: >1 to 30 days

Population: Full Analysis Set (all participants with Absorb GT1)

ArmMeasureGroupValue (NUMBER)
Absorb GT1 BVSNumber of Participants With Sub Acute Scaffold Thrombosis (ST)Definite0 participants
Absorb GT1 BVSNumber of Participants With Sub Acute Scaffold Thrombosis (ST)Probable0 participants
Absorb GT1 BVSNumber of Participants With Sub Acute Scaffold Thrombosis (ST)Definite/Probable0 participants
Primary

Number of Participants With Very Late Scaffold Thrombosis (ST)

Criteria: ST rate (in 2,000 patients : sum of Phase 1 and Phase 2),Success Criteria: ST rate at 3 months is ≤ 18 patients (0.9%). Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation; Subacute scaffold/stent thrombosis: \>24 hours - 30 days post stent implantation; Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation; Very late scaffold/stent thrombosis: \>1 year post stent implantation

Time frame: 1096 - 1460 days

Population: Full Analysis Set (all participants with Absorb GT1)

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Absorb GT1 BVSNumber of Participants With Very Late Scaffold Thrombosis (ST)Definite0 Participants
Absorb GT1 BVSNumber of Participants With Very Late Scaffold Thrombosis (ST)Probable0 Participants
Absorb GT1 BVSNumber of Participants With Very Late Scaffold Thrombosis (ST)Definite/Probable0 Participants
Primary

Number of Participants With Very Late Scaffold Thrombosis (ST)

Criteria: ST rate (in 2,000 patients : sum of Phase 1 and Phase 2),Success Criteria: ST rate at 3 months is ≤ 18 patients (0.9%). Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation; Subacute scaffold/stent thrombosis: \>24 hours - 30 days post stent implantation; Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation; Very late scaffold/stent thrombosis: \>1 year post stent implantation.

Time frame: 366 to 730 days

Population: The number of participants analyzed includes subjects who had available follow-up data at that time frame. The analysis excludes subjects who are truly lost to follow-up

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Absorb GT1 BVSNumber of Participants With Very Late Scaffold Thrombosis (ST)Definite0 Participants
Absorb GT1 BVSNumber of Participants With Very Late Scaffold Thrombosis (ST)Probable0 Participants
Absorb GT1 BVSNumber of Participants With Very Late Scaffold Thrombosis (ST)Definite/Probable0 Participants
Secondary

Angiographic Endpoints (Core Lab Analysis): Acute Gain (In-Segment )

The acute gain was defined as the difference between post- and pre procedural minimal lumen diameter (MLD).

Time frame: Post-procedure (average procedure time of 54.8 ± 27.6 min)

Population: Full Analysis Set (all participants with Absorb GT1)

ArmMeasureValue (MEAN)Dispersion
Absorb GT1 BVSAngiographic Endpoints (Core Lab Analysis): Acute Gain (In-Segment )1.29 mmStandard Deviation 0.44
Secondary

Angiographic Endpoints (Core Lab Analysis): Distal RVD

Distal RVD (can be measured after successful post-dilatation)

Time frame: Pre-procedure

Population: Full Analysis Set (all participants with Absorb GT1)

ArmMeasureValue (MEAN)Dispersion
Absorb GT1 BVSAngiographic Endpoints (Core Lab Analysis): Distal RVD2.95 mmStandard Deviation 0.39
Secondary

Angiographic Endpoints (Core Lab Analysis): %DS (In-Segment )

Percent Diameter Stenosis is defined as the value calculated as 100 \* (1 - Minimum Luminal Diameter (MLD)/Reference vessel diameter (RVD)) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA). In- Segment is defined as, within the margins of the stent or scaffold and 5 mm proximal and 5 mm distal to the stent or scaffold.

Time frame: Post-procedure (average procedure time of 54.8 ± 27.6 min)

Population: Full Analysis Set (all participants with Absorb GT1)

ArmMeasureValue (MEAN)Dispersion
Absorb GT1 BVSAngiographic Endpoints (Core Lab Analysis): %DS (In-Segment )18.4 percentage of diameterStandard Deviation 6.3
Secondary

Angiographic Endpoints (Core Lab Analysis): Lesion Length

Lesion Length (can be measured after successful post-dilatation)

Time frame: Pre-procedure

Population: Full Analysis Set (all participants with Absorb GT1)

ArmMeasureValue (MEAN)Dispersion
Absorb GT1 BVSAngiographic Endpoints (Core Lab Analysis): Lesion Length13.84 mmStandard Deviation 4.74
Secondary

Angiographic Endpoints (Core Lab Analysis): Lesion Morphology

Time frame: Pre-procedure

Population: Full Analysis Set (all participants with Absorb GT1)

ArmMeasureGroupValue (NUMBER)
Absorb GT1 BVSAngiographic Endpoints (Core Lab Analysis): Lesion MorphologyACC/AHA Type B2/C51.8 percentage of lesions
Absorb GT1 BVSAngiographic Endpoints (Core Lab Analysis): Lesion MorphologySevere/Moderate Calcification11.5 percentage of lesions
Absorb GT1 BVSAngiographic Endpoints (Core Lab Analysis): Lesion MorphologyEccentric27.3 percentage of lesions
Absorb GT1 BVSAngiographic Endpoints (Core Lab Analysis): Lesion MorphologyTotal Occlusion0.0 percentage of lesions
Secondary

Angiographic Endpoints (Core Lab Analysis): Minimum Lumen Diameter (MLD)

Angiographic endpoint Minimum lumen diameter is defined as the shortest diameter through the center point of the lumen

Time frame: Pre-procedure

Population: Full Analysis Set (all participants with Absorb GT1)

ArmMeasureValue (MEAN)Dispersion
Absorb GT1 BVSAngiographic Endpoints (Core Lab Analysis): Minimum Lumen Diameter (MLD)1.00 mmStandard Deviation 0.3
Secondary

Angiographic Endpoints (Core Lab Analysis): MLD (In-segment)

Angiographic endpoint. Minimum lumen diameter is defined as the shortest diameter through the center point of the lumen. In- Segment is defined as, within the margins of the stent or scaffold and 5 mm proximal and 5 mm distal to the stent or scaffold.

Time frame: Post-procedure (average procedure time of 54.8 ± 27.6 min)

Population: Full Analysis Set (all participants with Absorb GT1)

ArmMeasureValue (MEAN)Dispersion
Absorb GT1 BVSAngiographic Endpoints (Core Lab Analysis): MLD (In-segment)2.30 mmStandard Deviation 0.38
Secondary

Angiographic Endpoints (Core Lab Analysis): Percent Diameter Stenosis (%DS)

Percent Diameter Stenosis is defined as the value calculated as 100 \* (1 - Minimum Luminal Diameter (MLD)/Reference vessel diameter (RVD)) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA).

Time frame: Pre-procedure

Population: Full Analysis Set (all participants with Absorb GT1)

ArmMeasureValue (MEAN)Dispersion
Absorb GT1 BVSAngiographic Endpoints (Core Lab Analysis): Percent Diameter Stenosis (%DS)63.1 percentage of diameterStandard Deviation 9.5
Secondary

Angiographic Endpoints (Core Lab Analysis): Proximal Reference Vessel Diameter (RVD)

Proximal RVD (can be measured after successful post-dilatation)

Time frame: Pre-procedure

Population: Full Analysis Set (all participants with Absorb GT1)

ArmMeasureValue (MEAN)Dispersion
Absorb GT1 BVSAngiographic Endpoints (Core Lab Analysis): Proximal Reference Vessel Diameter (RVD)3.15 mmStandard Deviation 0.49
Secondary

Angiographic Endpoints (Core Lab Analysis): Thrombolysis in Myocardial Infarction (TIMI) Blood Flow

TIMI 0 flow (no perfusion) refers to the absence of any antegrade flow beyond a coronary occlusion. TIMI 1 flow (penetration without perfusion) is faint antegrade coronary flow beyond the occlusion, with incomplete filling of the distal coronary bed. TIMI 2 flow (partial reperfusion) is delayed or sluggish antegrade flow with complete filling of the distal territory. TIMI 3 is normal flow which fills the distal coronary bed completely

Time frame: Post-procedure (average procedure time of 54.8 ± 27.6 min)

Population: Full Analysis Set (all participants with Absorb GT1)

ArmMeasureGroupValue (NUMBER)
Absorb GT1 BVSAngiographic Endpoints (Core Lab Analysis): Thrombolysis in Myocardial Infarction (TIMI) Blood Flow00.00 percentage of TIMI flow
Absorb GT1 BVSAngiographic Endpoints (Core Lab Analysis): Thrombolysis in Myocardial Infarction (TIMI) Blood Flow10.72 percentage of TIMI flow
Absorb GT1 BVSAngiographic Endpoints (Core Lab Analysis): Thrombolysis in Myocardial Infarction (TIMI) Blood Flow21.44 percentage of TIMI flow
Absorb GT1 BVSAngiographic Endpoints (Core Lab Analysis): Thrombolysis in Myocardial Infarction (TIMI) Blood Flow397.84 percentage of TIMI flow
Secondary

Angiographic Endpoints (Core Lab Analysis):Thrombolysis in Myocardial Infarction (TIMI) Blood Flow

TIMI 0 flow (no perfusion) refers to the absence of any antegrade flow beyond a coronary occlusion. TIMI 1 flow (penetration without perfusion) is faint antegrade coronary flow beyond the occlusion, with incomplete filling of the distal coronary bed. TIMI 2 flow (partial reperfusion) is delayed or sluggish antegrade flow with complete filling of the distal territory. TIMI 3 is normal flow which fills the distal coronary bed completely

Time frame: Pre-procedure

Population: Full Analysis Set (all participants with Absorb GT1)

ArmMeasureGroupValue (NUMBER)
Absorb GT1 BVSAngiographic Endpoints (Core Lab Analysis):Thrombolysis in Myocardial Infarction (TIMI) Blood Flow00.00 percentage of TIMI flow
Absorb GT1 BVSAngiographic Endpoints (Core Lab Analysis):Thrombolysis in Myocardial Infarction (TIMI) Blood Flow10.72 percentage of TIMI flow
Absorb GT1 BVSAngiographic Endpoints (Core Lab Analysis):Thrombolysis in Myocardial Infarction (TIMI) Blood Flow22.16 percentage of TIMI flow
Absorb GT1 BVSAngiographic Endpoints (Core Lab Analysis):Thrombolysis in Myocardial Infarction (TIMI) Blood Flow397.12 percentage of TIMI flow
Secondary

IVUS/OCT Endpoints (Core Lab Analysis): Lumen Diameter or Lumen Area (Proximal/Distal)

Time frame: Pre-procedure (or after pre-dilatation)

Population: The number of participants analyzed includes subjects who had available follow-up data at that time frame. The analysis excludes subjects who are truly lost to follow-up

ArmMeasureGroupValue (MEAN)Dispersion
Absorb GT1 BVSIVUS/OCT Endpoints (Core Lab Analysis): Lumen Diameter or Lumen Area (Proximal/Distal)Proximal8.04 mm^2Standard Deviation 2.51
Absorb GT1 BVSIVUS/OCT Endpoints (Core Lab Analysis): Lumen Diameter or Lumen Area (Proximal/Distal)Distal6.29 mm^2Standard Deviation 2.3
Secondary

IVUS/OCT Endpoints (Core Lab Analysis): Lumen Diameter or Lumen Area (Proximal/Distal)

Time frame: Post-procedure (average procedure time of 54.8 ± 27.6 min)

Population: Full Analysis Set (all participants with Absorb GT1)

ArmMeasureGroupValue (MEAN)Dispersion
Absorb GT1 BVSIVUS/OCT Endpoints (Core Lab Analysis): Lumen Diameter or Lumen Area (Proximal/Distal)Distal6.54 mm^2Standard Deviation 2.21
Absorb GT1 BVSIVUS/OCT Endpoints (Core Lab Analysis): Lumen Diameter or Lumen Area (Proximal/Distal)Proximal8.21 mm^2Standard Deviation 2.47
Secondary

IVUS/OCT Endpoints (Core Lab Analysis): Minimal Lumen Area

Time frame: Post-procedure (average procedure time of 54.8 ± 27.6 min)

Population: Full Analysis Set (all participants with Absorb GT1).

ArmMeasureValue (MEAN)Dispersion
Absorb GT1 BVSIVUS/OCT Endpoints (Core Lab Analysis): Minimal Lumen Area6.86 mm^2Standard Deviation 1.77
Secondary

IVUS/OCT Endpoints (Core Lab Analysis): Percentage of Lesions With Strut Malapposition

Percentage of lesions with strut malapposition will be calculated as mean ± standard deviation post-procedure

Time frame: Post-procedure (average procedure time of 54.8 ± 27.6 min)

Population: Full Analysis Set (all participants with Absorb GT1)

ArmMeasureValue (MEAN)Dispersion
Absorb GT1 BVSIVUS/OCT Endpoints (Core Lab Analysis): Percentage of Lesions With Strut Malapposition1.89 Percentage of lesionsStandard Deviation 3.63
Secondary

IVUS/OCT Endpoints (Core Lab Analysis): Percentage of Strut Fracture

Strut fracture will be measured as either number or percentage post-procedure

Time frame: Post-procedure (average procedure time of 54.8 ± 27.6 min)

Population: Full Analysis Set (all participants with Absorb GT1)

ArmMeasureGroupValue (NUMBER)
Absorb GT1 BVSIVUS/OCT Endpoints (Core Lab Analysis): Percentage of Strut FractureYes1 Lesions
Absorb GT1 BVSIVUS/OCT Endpoints (Core Lab Analysis): Percentage of Strut FractureNo138 Lesions
Secondary

Number of All Death (Cardiac, Vascular, Non-Cardiovascular)

Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.

Time frame: 0 to 2 years

Population: The number of participants analyzed includes subjects who had available follow-up data at that time frame. The analysis excludes subjects who are truly lost to follow-up

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Absorb GT1 BVSNumber of All Death (Cardiac, Vascular, Non-Cardiovascular)2 Participants
Secondary

Number of All Death (Cardiac, Vascular, Non-Cardiovascular)

Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.

Time frame: 0 to 1 year

Population: Full Analysis Set (all participants with Absorb GT1)

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Absorb GT1 BVSNumber of All Death (Cardiac, Vascular, Non-Cardiovascular)0 Participants
Secondary

Number of All Death (Cardiac, Vascular, Non-Cardiovascular)

Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.

Time frame: 3 years

Population: The number of participants analyzed includes subjects who had available follow-up data at that time frame. The analysis excludes subjects who are truly lost to follow-up

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Absorb GT1 BVSNumber of All Death (Cardiac, Vascular, Non-Cardiovascular)3 Participants
Secondary

Number of All Death (Cardiac, Vascular, Non-Cardiovascular)

Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.

Time frame: 4 years

Population: Full Analysis Set (all participants with Absorb GT1)

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Absorb GT1 BVSNumber of All Death (Cardiac, Vascular, Non-Cardiovascular)4 Participants
Secondary

Number of All Death (Cardiac, Vascular, Non-Cardiovascular)

Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.

Time frame: 0 to 90 days

Population: Full Analysis Set (all participants with Absorb GT1)

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Absorb GT1 BVSNumber of All Death (Cardiac, Vascular, Non-Cardiovascular)0 Participants
Secondary

Number of All Death (Cardiac, Vascular, Non-Cardiovascular)

Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.

Time frame: 5 years

Population: Full Analysis Set (all participants with Absorb GT1)

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Absorb GT1 BVSNumber of All Death (Cardiac, Vascular, Non-Cardiovascular)4 Participants
Secondary

Number of All Death (Cardiac, Vascular, Non-Cardiovascular)

Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.

Time frame: 0 to 30 days

Population: Full Analysis Set (all participants with Absorb GT1)

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Absorb GT1 BVSNumber of All Death (Cardiac, Vascular, Non-Cardiovascular)0 Participants
Secondary

Number of Cardiac Death/TV-MI/ID-TLR (TLF)

Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).

Time frame: 0 to 90 days

Population: Full Analysis Set (all participants with Absorb GT1)

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Absorb GT1 BVSNumber of Cardiac Death/TV-MI/ID-TLR (TLF)0 Participants
Secondary

Number of Cardiac Death/TV-MI/ID-TLR (TLF)

Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).

Time frame: 0 to 30 days

Population: Full Analysis Set (all participants with Absorb GT1)

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Absorb GT1 BVSNumber of Cardiac Death/TV-MI/ID-TLR (TLF)0 Participants
Secondary

Number of Cardiac Death/TV-MI/ID-TLR (TLF)

Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).

Time frame: 0 to 2 years

Population: The number of participants analyzed includes subjects who had available follow-up data at that time frame. The analysis excludes subjects who are truly lost to follow-up

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Absorb GT1 BVSNumber of Cardiac Death/TV-MI/ID-TLR (TLF)3 Participants
Secondary

Number of Cardiac Death/TV-MI/ID-TLR (TLF)

Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).

Time frame: 3 years

Population: Full Analysis Set (all participants with Absorb GT1)

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Absorb GT1 BVSNumber of Cardiac Death/TV-MI/ID-TLR (TLF)5 Participants
Secondary

Number of Cardiac Death/TV-MI/ID-TLR (TLF)

Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).

Time frame: 5 years

Population: Full Analysis Set (all participants with Absorb GT1)

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Absorb GT1 BVSNumber of Cardiac Death/TV-MI/ID-TLR (TLF)6 Participants
Secondary

Number of Cardiac Death/TV-MI/ID-TLR (TLF)

Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).

Time frame: 4 years

Population: Full Analysis Set (all participants with Absorb GT1)

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Absorb GT1 BVSNumber of Cardiac Death/TV-MI/ID-TLR (TLF)6 Participants
Secondary

Number of Cardiac Death/TV-MI/ID-TLR (TLF)

Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).

Time frame: 0 to 1 year

Population: Full Analysis Set (all participants with Absorb GT1)

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Absorb GT1 BVSNumber of Cardiac Death/TV-MI/ID-TLR (TLF)0 Participants
Secondary

Number of Death/MI/All Revascularization (DMR)

DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization

Time frame: 0 to 1 year

Population: Full Analysis Set (all participants with Absorb GT1)

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Absorb GT1 BVSNumber of Death/MI/All Revascularization (DMR)3 Participants
Secondary

Number of Death/MI/All Revascularization (DMR)

DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization

Time frame: 0 to 2 years

Population: The number of participants analyzed includes subjects who had available follow-up data at that time frame. The analysis excludes subjects who are truly lost to follow-up

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Absorb GT1 BVSNumber of Death/MI/All Revascularization (DMR)11 Participants
Secondary

Number of Death/MI/All Revascularization (DMR)

DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization

Time frame: 4 years

Population: Full Analysis Set (all participants with Absorb GT1)

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Absorb GT1 BVSNumber of Death/MI/All Revascularization (DMR)22 Participants
Secondary

Number of Death/MI/All Revascularization (DMR)

DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization

Time frame: 0 to 30 days

Population: Full Analysis Set (all participants with Absorb GT1)

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Absorb GT1 BVSNumber of Death/MI/All Revascularization (DMR)1 Participants
Secondary

Number of Death/MI/All Revascularization (DMR)

DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization

Time frame: 0 to 90 days

Population: Full Analysis Set (all participants with Absorb GT1)

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Absorb GT1 BVSNumber of Death/MI/All Revascularization (DMR)1 Participants
Secondary

Number of Death/MI/All Revascularization (DMR)

DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization

Time frame: 3 years

Population: Full Analysis Set (all participants with Absorb GT1)

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Absorb GT1 BVSNumber of Death/MI/All Revascularization (DMR)16 Participants
Secondary

Number of Death/MI/All Revascularization (DMR)

DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.

Time frame: 5 years

Population: Full Analysis Set (all participants with Absorb GT1)

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Absorb GT1 BVSNumber of Death/MI/All Revascularization (DMR)23 Participants
Secondary

Number of Major Adverse Cardiac Event (MACE)

MACE is the composite of Cardiac death/All myocardial infarction (MI)/ Ischemia-driven Revascularization (ID-TLR)

Time frame: 0 to 90 days

Population: Full Analysis Set (all participants with Absorb GT1)

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Absorb GT1 BVSNumber of Major Adverse Cardiac Event (MACE)0 Participants
Secondary

Number of Major Adverse Cardiac Event (MACE)

MACE is the composite of Cardiac death/All myocardial infarction (MI)/ Ischemia-driven Revascularization (ID-TLR)

Time frame: 0 to 1 year

Population: Full Analysis Set (all participants with Absorb GT1)

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Absorb GT1 BVSNumber of Major Adverse Cardiac Event (MACE)0 Participants
Secondary

Number of Major Adverse Cardiac Event (MACE)

MACE is the composite of Cardiac death/All myocardial infarction (MI)/ Ischemia-driven Revascularization (ID-TLR)

Time frame: 0 to 30 days

Population: Full Analysis Set (all participants with Absorb GT1)

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Absorb GT1 BVSNumber of Major Adverse Cardiac Event (MACE)0 Participants
Secondary

Number of Major Adverse Cardiac Event (MACE)

MACE is the composite of Cardiac death/All myocardial infarction (MI)/ Ischemia-driven Revascularization (ID-TLR)

Time frame: 0 to 2 years

Population: The number of participants analyzed includes subjects who had available follow-up data at that time frame. The analysis excludes subjects who are truly lost to follow-up

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Absorb GT1 BVSNumber of Major Adverse Cardiac Event (MACE)3 Participants
Secondary

Number of Major Adverse Cardiac Event (MACE)

MACE is the composite of Cardiac death/All myocardial infarction (MI)/ Ischemia-driven Revascularization (ID-TLR)

Time frame: 3 years

Population: Full Analysis Set (all participants with Absorb GT1)

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Absorb GT1 BVSNumber of Major Adverse Cardiac Event (MACE)6 Participants
Secondary

Number of Major Adverse Cardiac Event (MACE)

MACE is the composite of Cardiac death/All myocardial infarction (MI)/ Ischemia-driven Revascularization (ID-TLR)

Time frame: 4 years

Population: Full Analysis Set (all participants with Absorb GT1)

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Absorb GT1 BVSNumber of Major Adverse Cardiac Event (MACE)7 Participants
Secondary

Number of Major Adverse Cardiac Event (MACE)

MACE is the composite of Cardiac death/All myocardial infarction (MI)/ Ischemia-driven Revascularization (ID-TLR).

Time frame: 5 years

Population: Full Analysis Set (all participants with Absorb GT1)

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Absorb GT1 BVSNumber of Major Adverse Cardiac Event (MACE)7 Participants
Secondary

Number of Participants With All Coronary Revascularization

All coronary revascularization is a composite of coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI)

Time frame: 0 to 90 days

Population: Full Analysis Set (all participants with Absorb GT1)

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Absorb GT1 BVSNumber of Participants With All Coronary Revascularization1 Participants
Secondary

Number of Participants With All Coronary Revascularization

All coronary revascularization is a composite of coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI)

Time frame: 0 to 30 days

Population: Full Analysis Set (all participants with Absorb GT1)

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Absorb GT1 BVSNumber of Participants With All Coronary Revascularization1 Participants
Secondary

Number of Participants With All Coronary Revascularization

All coronary revascularization is a composite of coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI)

Time frame: 3 years

Population: Full Analysis Set (all participants with Absorb GT1)

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Absorb GT1 BVSNumber of Participants With All Coronary Revascularization12 Participants
Secondary

Number of Participants With All Coronary Revascularization

All coronary revascularization is a composite of coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI)

Time frame: 4 years

Population: Full Analysis Set (all participants with Absorb GT1)

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Absorb GT1 BVSNumber of Participants With All Coronary Revascularization16 Participants
Secondary

Number of Participants With All Coronary Revascularization

All coronary revascularization is a composite of coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI)

Time frame: 0 to 1 year

Population: Full Analysis Set (all participants with Absorb GT1)

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Absorb GT1 BVSNumber of Participants With All Coronary Revascularization3 Participants
Secondary

Number of Participants With All Coronary Revascularization

All coronary revascularization is a composite of coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI)

Time frame: 0 to 2 years

Population: The number of participants analyzed includes subjects who had available follow-up data at that time frame. The analysis excludes subjects who are truly lost to follow-up

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Absorb GT1 BVSNumber of Participants With All Coronary Revascularization9 Participants
Secondary

Number of Participants With All Myocardial Infarction (MI)

Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. All myocardial infarction includes target vessel myocardial infarction (TV-MI) and not attributable to target vessel myocardial infarction (NTV-MI)

Time frame: 3 years

Population: Full Analysis Set (all participants with Absorb GT1)

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Absorb GT1 BVSNumber of Participants With All Myocardial Infarction (MI)2 Participants
Secondary

Number of Participants With All Myocardial Infarction (MI)

Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. All myocardial infarction includes target vessel myocardial infarction (TV-MI) and not attributable to target vessel myocardial infarction (NTV-MI)

Time frame: 0 to 1 year

Population: Full Analysis Set (all participants with Absorb GT1)

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Absorb GT1 BVSNumber of Participants With All Myocardial Infarction (MI)0 Participants
Secondary

Number of Participants With All Myocardial Infarction (MI)

Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. All myocardial infarction includes target vessel myocardial infarction (TV-MI) and not attributable to target vessel myocardial infarction (NTV-MI)

Time frame: 0 to 2 years

Population: The number of participants analyzed includes subjects who had available follow-up data at that time frame. The analysis excludes subjects who are truly lost to follow-up

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Absorb GT1 BVSNumber of Participants With All Myocardial Infarction (MI)0 Participants
Secondary

Number of Participants With All Myocardial Infarction (MI)

Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. All myocardial infarction includes target vessel myocardial infarction (TV-MI) and not attributable to target vessel myocardial infarction (NTV-MI)

Time frame: 0 to 30 days

Population: Full Analysis Set (all participants with Absorb GT1)

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Absorb GT1 BVSNumber of Participants With All Myocardial Infarction (MI)0 Participants
Secondary

Number of Participants With All Myocardial Infarction (MI)

Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. All myocardial infarction includes target vessel myocardial infarction (TV-MI) and not attributable to target vessel myocardial infarction (NTV-MI)

Time frame: 0 to 90 days

Population: Full Analysis Set (all participants with Absorb GT1)

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Absorb GT1 BVSNumber of Participants With All Myocardial Infarction (MI)0 Participants
Secondary

Number of Participants With All Myocardial Infarction (MI)

Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. All myocardial infarction includes target vessel myocardial infarction (TV-MI) and not attributable to target vessel myocardial infarction (NTV-MI)

Time frame: 4 years

Population: Full Analysis Set (all participants with Absorb GT1)

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Absorb GT1 BVSNumber of Participants With All Myocardial Infarction (MI)2 Participants
Secondary

Number of Participants With All Myocardial Infarction (MI)

Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. All myocardial infarction includes target vessel myocardial infarction (TV-MI) and not attributable to target vessel myocardial infarction (NTV-MI)

Time frame: 5 years

Population: Full Analysis Set (all participants with Absorb GT1)

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Absorb GT1 BVSNumber of Participants With All Myocardial Infarction (MI)2 Participants
Secondary

Number of Participants With All Target Lesion Revascularization (TLR)

Target Lesion Revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated \[CI\] or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement. The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent.

Time frame: 5 years

Population: Full Analysis Set (all participants with Absorb GT1)

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Absorb GT1 BVSNumber of Participants With All Target Lesion Revascularization (TLR)6 Participants
Secondary

Number of Participants With All Target Lesion Revascularization (TLR)

Target Lesion Revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated \[CI\] or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement. The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent.

Time frame: 0 to 30 days

Population: Full Analysis Set (all participants with Absorb GT1)

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Absorb GT1 BVSNumber of Participants With All Target Lesion Revascularization (TLR)1 Participants
Secondary

Number of Participants With All Target Lesion Revascularization (TLR)

Target Lesion Revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated \[CI\] or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement. The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent.

Time frame: 0 to 90 days

Population: Full Analysis Set (all participants with Absorb GT1)

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Absorb GT1 BVSNumber of Participants With All Target Lesion Revascularization (TLR)1 Participants
Secondary

Number of Participants With All Target Lesion Revascularization (TLR)

Target Lesion Revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated \[CI\] or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement. The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent.

Time frame: 4 years

Population: Full Analysis Set (all participants with Absorb GT1)

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Absorb GT1 BVSNumber of Participants With All Target Lesion Revascularization (TLR)6 Participants
Secondary

Number of Participants With All Target Lesion Revascularization (TLR)

Target Lesion Revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated \[CI\] or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement. The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent.

Time frame: 0 to 1 year

Population: Full Analysis Set (all participants with Absorb GT1)

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Absorb GT1 BVSNumber of Participants With All Target Lesion Revascularization (TLR)1 Participants
Secondary

Number of Participants With All Target Lesion Revascularization (TLR)

Target Lesion Revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated \[CI\] or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement. The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent.

Time frame: 3 years

Population: Full Analysis Set (all participants with Absorb GT1)

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Absorb GT1 BVSNumber of Participants With All Target Lesion Revascularization (TLR)4 Participants
Secondary

Number of Participants With All Target Lesion Revascularization (TLR)

Target Lesion Revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated \[CI\] or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement. The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent.

Time frame: 0 to 2 years

Population: The number of participants analyzed includes subjects who had available follow-up data at that time frame. The analysis excludes subjects who are truly lost to follow-up

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Absorb GT1 BVSNumber of Participants With All Target Lesion Revascularization (TLR)3 Participants
Secondary

Number of Participants With All Target Vessel Revascularization (TVR)

Target Vessel Revascularization (TVR) is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.

Time frame: 5 years

Population: Full Analysis Set (all participants with Absorb GT1)

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Absorb GT1 BVSNumber of Participants With All Target Vessel Revascularization (TVR)11 Participants
Secondary

Number of Participants With All Target Vessel Revascularization (TVR)

Target Vessel Revascularization (TVR) is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.

Time frame: 0 to 2 years

Population: The number of participants analyzed includes subjects who had available follow-up data at that time frame. The analysis excludes subjects who are truly lost to follow-up

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Absorb GT1 BVSNumber of Participants With All Target Vessel Revascularization (TVR)4 Participants
Secondary

Number of Participants With All Target Vessel Revascularization (TVR)

Target Vessel Revascularization (TVR) is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.

Time frame: 0 to 1 year

Population: Full Analysis Set (all participants with Absorb GT1)

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Absorb GT1 BVSNumber of Participants With All Target Vessel Revascularization (TVR)1 Participants
Secondary

Number of Participants With All Target Vessel Revascularization (TVR)

Target Vessel Revascularization (TVR) is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.

Time frame: 0 to 90 days

Population: Full Analysis Set (all participants with Absorb GT1)

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Absorb GT1 BVSNumber of Participants With All Target Vessel Revascularization (TVR)1 Participants
Secondary

Number of Participants With All Target Vessel Revascularization (TVR)

Target Vessel Revascularization (TVR) is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.

Time frame: 0 to 30 days

Population: Full Analysis Set (all participants with Absorb GT1)

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Absorb GT1 BVSNumber of Participants With All Target Vessel Revascularization (TVR)1 Participants
Secondary

Number of Participants With All Target Vessel Revascularization (TVR)

Target Vessel Revascularization (TVR) is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.

Time frame: 3 years

Population: Full Analysis Set (all participants with Absorb GT1)

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Absorb GT1 BVSNumber of Participants With All Target Vessel Revascularization (TVR)7 Participants
Secondary

Number of Participants With All Target Vessel Revascularization (TVR)

Target Vessel Revascularization (TVR) is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.

Time frame: 4 years

Population: Full Analysis Set (all participants with Absorb GT1)

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Absorb GT1 BVSNumber of Participants With All Target Vessel Revascularization (TVR)11 Participants
Secondary

Number of Participants With Cardiac Death/Myocardial Infarction (MI)

Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

Time frame: 3 years

Population: Full Analysis Set (all participants with Absorb GT1)

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Absorb GT1 BVSNumber of Participants With Cardiac Death/Myocardial Infarction (MI)3 Participants
Secondary

Number of Participants With Cardiac Death/Myocardial Infarction (MI)

Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

Time frame: 5 years

Population: Full Analysis Set (all participants with Absorb GT1)

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Absorb GT1 BVSNumber of Participants With Cardiac Death/Myocardial Infarction (MI)4 Participants
Secondary

Number of Participants With Cardiac Death/Myocardial Infarction (MI)

Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

Time frame: 4 years

Population: Full Analysis Set (all participants with Absorb GT1)

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Absorb GT1 BVSNumber of Participants With Cardiac Death/Myocardial Infarction (MI)4 Participants
Secondary

Number of Participants With Cardiac Death/Myocardial Infarction (MI)

Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

Time frame: 0 to 30 days

Population: Full Analysis Set (all participants with Absorb GT1)

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Absorb GT1 BVSNumber of Participants With Cardiac Death/Myocardial Infarction (MI)0 Participants
Secondary

Number of Participants With Cardiac Death/Myocardial Infarction (MI)

Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

Time frame: 0 to 2 years

Population: The number of participants analyzed includes subjects who had available follow-up data at that time frame. The analysis excludes subjects who are truly lost to follow-up

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Absorb GT1 BVSNumber of Participants With Cardiac Death/Myocardial Infarction (MI)1 Participants
Secondary

Number of Participants With Cardiac Death/Myocardial Infarction (MI)

Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

Time frame: 0 to 1 year

Population: Full Analysis Set (all participants with Absorb GT1)

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Absorb GT1 BVSNumber of Participants With Cardiac Death/Myocardial Infarction (MI)0 Participants
Secondary

Number of Participants With Cardiac Death/Myocardial Infarction (MI)

Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

Time frame: 0 to 90 days

Population: Full Analysis Set (all participants with Absorb GT1)

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Absorb GT1 BVSNumber of Participants With Cardiac Death/Myocardial Infarction (MI)0 Participants
Secondary

Number of Participants With 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: 0 to 1 Year

Population: Full Analysis Set (all participants with Absorb GT1)

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Absorb GT1 BVSNumber of Participants With Target Vessel Failure (TVF)0 Participants
Secondary

Number of Participants With 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: Full Analysis Set (all participants with Absorb GT1)

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Absorb GT1 BVSNumber of Participants With Target Vessel Failure (TVF)11 Participants
Secondary

Number of Participants With 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

Population: Full Analysis Set (all participants with Absorb GT1)

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Absorb GT1 BVSNumber of Participants With Target Vessel Failure (TVF)11 Participants
Secondary

Number of Participants With 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: Full Analysis Set (all participants with Absorb GT1)

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Absorb GT1 BVSNumber of Participants With Target Vessel Failure (TVF)8 Participants
Secondary

Number of Participants With 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: 0 to 2 years

Population: The number of participants analyzed includes subjects who had available follow-up data at that time frame. The analysis excludes subjects who are truly lost to follow-up

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Absorb GT1 BVSNumber of Participants With Target Vessel Failure (TVF)4 Participants
Secondary

Number of Participants With 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: 0 to 30 days

Population: Full Analysis Set (all participants with Absorb GT1)

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Absorb GT1 BVSNumber of Participants With Target Vessel Failure (TVF)0 Participants
Secondary

Number of Participants With 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: 0 to 90 days

Population: Full Analysis Set (all participants with Absorb GT1)

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Absorb GT1 BVSNumber of Participants With Target Vessel Failure (TVF)0 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026