Chronic Total Occlusion of Coronary Artery, Coronary Artery Disease, Coronary Artery Restenosis, Coronary Artery Stenosis, Coronary Disease, Coronary Occlusion, Coronary Restenosis
Conditions
Keywords
Angioplasty, Bioabsorbable, Bioresorbable, BVS, Coronary Artery Endothelial Responsiveness, Coronary Scaffold, Coronary Stent
Brief summary
ABSORB FIRST is a prospective, multi-center registry. The objectives of the study are to: * Provide ongoing post-market surveillance for documentation of safety, performance and clinical outcomes of the Absorb BVS (Bioresorbable Vascular Scaffold) System in daily percutaneous coronary intervention (PCI) practice per Instructions for Use (IFU, on-label use). * To evaluate the safety and performance of 12 mm or shorter Absorb BVS in single or overlapping use (bailout, optimization of long lesion treatment) for the treatment of patients with ischemic heart disease caused by de novo native coronary artery lesion(s) * Collect additional information (e.g. acute success) to evaluate handling and implantation of Absorb BVS by physicians under a wide range of commercial use conditions and following routine clinical practice.
Detailed description
the ABSORB FIRST Registry is intended to provide an assessment of the safety and performance of the Absorb BVS device in accordance to the IFU in real world use involving more complex patients, lesions and use (examples: longer lesions, overlapping use, bailout, patients at high risks for cardiac events, etc.). The ABSORB FIRST study will register a minimum of 1800 patients in approximately 90 sites throughout multiple countries worldwide where Absorb BVS has regulatory approval or is commercially available.
Interventions
Subjects receiving the Absorb Bioresorbable Vascular Scaffold
Sponsors
Abbott Medical Devices
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* The inclusion criteria must follow the most recent IFU which may include but are not limited to the following: * Patient must be at least 18 years of age at the time of signing the Informed Consent Form * Patient is to be treated for de novo lesions located in previously untreated vessels. * Patient must agree to undergo all required follow-up visits and data collection.
Exclusion criteria
* The
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cardiac Death/TV-MI/ID-TLR (Target Lesion Failure (TLF)) | 0 to 407 days | Target Lesion Failure includes Cardiac Death,Target Vessel-Myocardial Infarction and Ischemic Driven-Target Lesion Revascularization. This is one of the Composite Clinical Endpoints (Safety and Efficacy, hierarchical). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acute Success: Clinical Procedure Success (Per Subject Analysis) | During the hospital stay with a maximum of 3 days post index procedure | Procedure success was defined as the achievement of a final in-scaffold diameter stenosis of \<50% by online quantitative coronary angiography (QCA) or visual estimation using Absorb BVS, with or without any adjunctive devices, and without the occurrence of cardiac death, target vessel MI (Q-wave and non-Q-wave MI), or repeat revascularization of the target lesion within 3 days of the index procedure. |
| Acute Scaffold Thrombosis | <1 day | — |
| Subacute ScaffoldThrombosis | 1 to 30 days | — |
| Late Scaffold Thrombosis | 31 to 365 Days | — |
| All Death, All MI, All Revascularization (DMR) | 0 to 7 days (In-hospital) | — |
| Cardiac Death/All MI/ID-TVR (Target Vessel Failure (TVF) | 0 to 7 days (In-hospital) | Target Vessel Failure (TVF) includes Cardiac Death, All Myocardial Infarction and Ischemic Driven-Target Vessel Revascularization. This is one of the Composite Clinical Endpoints (Safety and Efficacy, hierarchical). |
| Major Adverse Cardiac Event (MACE) | 0 to 7 days (In-hospital) | MACE includes Cardiac Death, All Myocardial Infarction and Ischemic Driven-Target Lesion Revascularization. This is one of the Composite Clinical Endpoints (Safety and Efficacy, hierarchical). |
| Cardiac Death/TV-MI/ID-TLR (Target Lesion Failure (TLF)) | 0 to 7 days (In-hospital) | Target Lesion Failure includes Cardiac Death,Target Vessel-Myocardial Infarction and Ischemic Driven-Target Lesion Revascularization. This is one of the Composite Clinical Endpoints (Safety and Efficacy, hierarchical). |
| Acute Success: Clinical Device Success (Lesion Level Analysis) | < or = 1 day | Device success was defined as the achievement of a final in-scaffold residual diameter stenosis of \<50% assessed by online quantitative angiography or visual estimation, using Absorb BVS and without a device deficiency. A device was considered to have failed if it did not meet the requirements of the definition for clinical device success. |
| All Death/All MI | 0 to 7 days (In-hospital) | — |
| Death (Cardiovascular, Non-Cardiovascular) | 0 to 7 days (In-hospital) | This is one of the Safety Component (non-hierarchical) endpoints. |
| All Myocardial Infarction (MI): Q-wave MI (QMI) and Non-QMI (NQMI), TV, and Non-TV (NTV). | 0 to 7 days (In-hospital) | This is one of the Safety Component (non-hierarchical) endpoints. |
| Target Lesion Revascularization (TLR): All TLR | 0 to 7 days (In-hospital) | This is one of the Efficacy Component (non-hierarchical) endpoints. |
| Target Lesion Revascularization : Ischemia-Driven (ID-TLR) | 0 to 7 days (In-hospital) | This is one of the Efficacy Component (non-hierarchical) endpoints. |
| Target Vessel Revascularization (TVR): All TVR | 0 to 7 days (In-hospital) | This is one of the Efficacy Component (non-hierarchical) endpoints. |
| Target Vessel Revascularization : Ischemic-driven (ID-TVR) | 0 to 7 days (In-hospital) | This is one of the Efficacy Component (non-hierarchical) endpoints. |
| All Revascularization | 0 to 7 days (In-hospital) | This is one of the Efficacy Component (non-hierarchical) endpoints. |
| Cardiac Death/All MI | 0 to 7 days (In-hospital) | — |
Countries
Belgium
Participant flow
Recruitment details
A total of 1800 subjects were enrolled at 87 outside US (OUS) study sites across 21 counties worldwide. The first patient registered on January 21, 2013. The patient registration was complete on Aug 30, 2014, and the last patient completed the 1-year clinical follow-up on Sep 09, 2015. The database has been closed on Oct 30, 2015.
Pre-assignment details
A total of 81 subjects are discontinued from the study population (1800) due to death:17, withdrawal of consent:5, withdrawn by physician:2, loss to follow-up:53 and unknown reasons:4. A total of 28 subjects with MI/revascularization events or reached 1-year follow-up window were included in the clinical outcome analysis.
Participants by arm
| Arm | Count |
|---|---|
| Absorb Bioresorbable Vascular Scaffold Subjects receiving the Absorb Bioresorbable Vascular Scaffold | 1,800 |
| Total | 1,800 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 17 |
| Overall Study | Lost to Follow-up | 53 |
| Overall Study | Physician Decision | 2 |
| Overall Study | Subjects withdrawn consent | 5 |
| Overall Study | Unknown reason | 4 |
Baseline characteristics
| Characteristic | Absorb Bioresorbable Vascular Scaffold |
|---|---|
| Age, Continuous | 58.8 years STANDARD_DEVIATION 11 |
| Region of Enrollment Austria | 51 participants |
| Region of Enrollment Bahrain | 33 participants |
| Region of Enrollment Belgium | 119 participants |
| Region of Enrollment Colombia | 74 participants |
| Region of Enrollment France | 59 participants |
| Region of Enrollment Germany | 378 participants |
| Region of Enrollment Indonesia | 64 participants |
| Region of Enrollment Italy | 12 participants |
| Region of Enrollment Jordan | 37 participants |
| Region of Enrollment Malaysia | 88 participants |
| Region of Enrollment Netherlands | 144 participants |
| Region of Enrollment New Zealand | 42 participants |
| Region of Enrollment Philippines | 5 participants |
| Region of Enrollment Poland | 22 participants |
| Region of Enrollment Saudi Arabia | 39 participants |
| Region of Enrollment Singapore | 93 participants |
| Region of Enrollment Spain | 308 participants |
| Region of Enrollment Switzerland | 59 participants |
| Region of Enrollment Thailand | 75 participants |
| Region of Enrollment United Arab Emirates | 65 participants |
| Region of Enrollment Vietnam | 33 participants |
| Sex: Female, Male Female | 362 Participants |
| Sex: Female, Male Male | 1438 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 395 / 1,800 |
| serious Total, serious adverse events | 249 / 1,800 |
Outcome results
Primary
Cardiac Death/TV-MI/ID-TLR (Target Lesion Failure (TLF))
Target Lesion Failure includes Cardiac Death,Target Vessel-Myocardial Infarction and Ischemic Driven-Target Lesion Revascularization. This is one of the Composite Clinical Endpoints (Safety and Efficacy, hierarchical).
Time frame: 0 to 407 days
Population: Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Absorb Bioresorbable Vascular Scaffold | Cardiac Death/TV-MI/ID-TLR (Target Lesion Failure (TLF)) | 2.8 percentage of participants |
Secondary
Acute Scaffold Thrombosis
Time frame: <1 day
Population: Analysis population excludes subjects who are truly lost-to-follow-up, defined as subjects who are terminated through a given time point without any Scaffold Thrombosis event.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Absorb Bioresorbable Vascular Scaffold | Acute Scaffold Thrombosis | Probable | 1 percentage of participants |
| Absorb Bioresorbable Vascular Scaffold | Acute Scaffold Thrombosis | Definite | 0 percentage of participants |
| Absorb Bioresorbable Vascular Scaffold | Acute Scaffold Thrombosis | Definite/Probable | 1 percentage of participants |
Secondary
Acute Success: Clinical Device Success (Lesion Level Analysis)
Device success was defined as the achievement of a final in-scaffold residual diameter stenosis of \<50% assessed by online quantitative angiography or visual estimation, using Absorb BVS and without a device deficiency. A device was considered to have failed if it did not meet the requirements of the definition for clinical device success.
Time frame: < or = 1 day
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Absorb Bioresorbable Vascular Scaffold | Acute Success: Clinical Device Success (Lesion Level Analysis) | 98.0 percentage of lesions |
Secondary
Acute Success: Clinical Procedure Success (Per Subject Analysis)
Procedure success was defined as the achievement of a final in-scaffold diameter stenosis of \<50% by online quantitative coronary angiography (QCA) or visual estimation using Absorb BVS, with or without any adjunctive devices, and without the occurrence of cardiac death, target vessel MI (Q-wave and non-Q-wave MI), or repeat revascularization of the target lesion within 3 days of the index procedure.
Time frame: During the hospital stay with a maximum of 3 days post index procedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Absorb Bioresorbable Vascular Scaffold | Acute Success: Clinical Procedure Success (Per Subject Analysis) | 97.0 percentage of participants |
Secondary
All Death/All MI
Time frame: 0 to 180 days
Population: Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Absorb Bioresorbable Vascular Scaffold | All Death/All MI | 2.0 percentage of participants |
Secondary
All Death/All MI
Time frame: 0 to 407 days
Population: Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Absorb Bioresorbable Vascular Scaffold | All Death/All MI | 2.3 percentage of participants |
Secondary
All Death/All MI
Time frame: 0 to 37 days
Population: Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Absorb Bioresorbable Vascular Scaffold | All Death/All MI | 1.1 percentage of participants |
Secondary
All Death/All MI
Time frame: 0 to 7 days (In-hospital)
Population: Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Absorb Bioresorbable Vascular Scaffold | All Death/All MI | 0.8 percentage of participants |
Secondary
All Death, All MI, All Revascularization (DMR)
Time frame: 0 to 180 days
Population: Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Absorb Bioresorbable Vascular Scaffold | All Death, All MI, All Revascularization (DMR) | 6.5 percentage of participants |
Secondary
All Death, All MI, All Revascularization (DMR)
Time frame: 0 to 7 days (In-hospital)
Population: Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Absorb Bioresorbable Vascular Scaffold | All Death, All MI, All Revascularization (DMR) | 1.9 percentage of participants |
Secondary
All Death, All MI, All Revascularization (DMR)
Time frame: 0 to 37 days
Population: Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Absorb Bioresorbable Vascular Scaffold | All Death, All MI, All Revascularization (DMR) | 3.0 percentage of participants |
Secondary
All Death, All MI, All Revascularization (DMR)
Time frame: 0 to 407 days
Population: Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Absorb Bioresorbable Vascular Scaffold | All Death, All MI, All Revascularization (DMR) | 8.4 percentage of participants |
Secondary
All Myocardial Infarction (MI): Q-wave MI (QMI) and Non-QMI (NQMI), TV, and Non-TV (NTV).
This is one of the Safety Component (non-hierarchical) endpoints.
Time frame: 0 to 180 days
Population: Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Absorb Bioresorbable Vascular Scaffold | All Myocardial Infarction (MI): Q-wave MI (QMI) and Non-QMI (NQMI), TV, and Non-TV (NTV). | 1.3 percentage of participants |
Secondary
All Myocardial Infarction (MI): Q-wave MI (QMI) and Non-QMI (NQMI), TV, and Non-TV (NTV).
This is one of the Safety Component (non-hierarchical) endpoints.
Time frame: 0 to 407 days
Population: Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Absorb Bioresorbable Vascular Scaffold | All Myocardial Infarction (MI): Q-wave MI (QMI) and Non-QMI (NQMI), TV, and Non-TV (NTV). | 1.4 percentage of participants |
Secondary
All Myocardial Infarction (MI): Q-wave MI (QMI) and Non-QMI (NQMI), TV, and Non-TV (NTV).
This is one of the Safety Component (non-hierarchical) endpoints.
Time frame: 0 to 7 days (In-hospital)
Population: Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Absorb Bioresorbable Vascular Scaffold | All Myocardial Infarction (MI): Q-wave MI (QMI) and Non-QMI (NQMI), TV, and Non-TV (NTV). | 0.7 percentage of participants |
Secondary
All Myocardial Infarction (MI): Q-wave MI (QMI) and Non-QMI (NQMI), TV, and Non-TV (NTV).
This is one of the Safety Component (non-hierarchical) endpoints.
Time frame: 0 to 37 days
Population: Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Absorb Bioresorbable Vascular Scaffold | All Myocardial Infarction (MI): Q-wave MI (QMI) and Non-QMI (NQMI), TV, and Non-TV (NTV). | 1.0 percentage of participants |
Secondary
All Revascularization
This is one of the Efficacy Component (non-hierarchical) endpoints.
Time frame: 0 to 407 days
Population: Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Absorb Bioresorbable Vascular Scaffold | All Revascularization | 7.3 percentage of participants |
Secondary
All Revascularization
This is one of the Efficacy Component (non-hierarchical) endpoints.
Time frame: 0 to 7 days (In-hospital)
Population: Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Absorb Bioresorbable Vascular Scaffold | All Revascularization | 1.4 percentage of participants |
Secondary
All Revascularization
This is one of the Efficacy Component (non-hierarchical) endpoints.
Time frame: 0 to 37 days
Population: Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Absorb Bioresorbable Vascular Scaffold | All Revascularization | 2.5 percentage of participants |
Secondary
All Revascularization
This is one of the Efficacy Component (non-hierarchical) endpoints.
Time frame: 0 to 180 days
Population: Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Absorb Bioresorbable Vascular Scaffold | All Revascularization | 5.5 percentage of participants |
Secondary
Cardiac Death/All MI
Time frame: 0 to 7 days (In-hospital)
Population: Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Absorb Bioresorbable Vascular Scaffold | Cardiac Death/All MI | 0.8 percentage of participants |
Secondary
Cardiac Death/All MI
Time frame: 0 to 37 days
Population: Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Absorb Bioresorbable Vascular Scaffold | Cardiac Death/All MI | 1.1 percentage of participants |
Secondary
Cardiac Death/All MI
Time frame: 0 to 180 days
Population: Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Absorb Bioresorbable Vascular Scaffold | Cardiac Death/All MI | 1.9 percentage of participants |
Secondary
Cardiac Death/All MI
Time frame: 0 to 407 days
Population: Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Absorb Bioresorbable Vascular Scaffold | Cardiac Death/All MI | 2.1 percentage of participants |
Secondary
Cardiac Death/All MI/ID-TVR (Target Vessel Failure (TVF)
Target Vessel Failure (TVF) includes Cardiac Death, All Myocardial Infarction and Ischemic Driven-Target Vessel Revascularization. This is one of the Composite Clinical Endpoints (Safety and Efficacy, hierarchical).
Time frame: 0 to 180 days
Population: Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Absorb Bioresorbable Vascular Scaffold | Cardiac Death/All MI/ID-TVR (Target Vessel Failure (TVF) | 2.8 percentage of participants |
Secondary
Cardiac Death/All MI/ID-TVR (Target Vessel Failure (TVF)
Target Vessel Failure (TVF) includes Cardiac Death, All Myocardial Infarction and Ischemic Driven-Target Vessel Revascularization. This is one of the Composite Clinical Endpoints (Safety and Efficacy, hierarchical).
Time frame: 0 to 37 days
Population: Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Absorb Bioresorbable Vascular Scaffold | Cardiac Death/All MI/ID-TVR (Target Vessel Failure (TVF) | 1.4 percentage of participants |
Secondary
Cardiac Death/All MI/ID-TVR (Target Vessel Failure (TVF)
Target Vessel Failure (TVF) includes Cardiac Death, All Myocardial Infarction and Ischemic Driven-Target Vessel Revascularization. This is one of the Composite Clinical Endpoints (Safety and Efficacy, hierarchical).
Time frame: 0 to 407 days
Population: Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Absorb Bioresorbable Vascular Scaffold | Cardiac Death/All MI/ID-TVR (Target Vessel Failure (TVF) | 3.7 percentage of participants |
Secondary
Cardiac Death/All MI/ID-TVR (Target Vessel Failure (TVF)
Target Vessel Failure (TVF) includes Cardiac Death, All Myocardial Infarction and Ischemic Driven-Target Vessel Revascularization. This is one of the Composite Clinical Endpoints (Safety and Efficacy, hierarchical).
Time frame: 0 to 7 days (In-hospital)
Population: Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Absorb Bioresorbable Vascular Scaffold | Cardiac Death/All MI/ID-TVR (Target Vessel Failure (TVF) | 1.0 percentage of participants |
Secondary
Cardiac Death/TV-MI/ID-TLR (Target Lesion Failure (TLF))
Target Lesion Failure includes Cardiac Death,Target Vessel-Myocardial Infarction and Ischemic Driven-Target Lesion Revascularization. This is one of the Composite Clinical Endpoints (Safety and Efficacy, hierarchical).
Time frame: 0 to 37 Days
Population: Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Absorb Bioresorbable Vascular Scaffold | Cardiac Death/TV-MI/ID-TLR (Target Lesion Failure (TLF)) | 1.1 percentage of participants |
Secondary
Cardiac Death/TV-MI/ID-TLR (Target Lesion Failure (TLF))
Target Lesion Failure includes Cardiac Death,Target Vessel-Myocardial Infarction and Ischemic Driven-Target Lesion Revascularization. This is one of the Composite Clinical Endpoints (Safety and Efficacy, hierarchical).
Time frame: 0 to 7 days (In-hospital)
Population: Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Absorb Bioresorbable Vascular Scaffold | Cardiac Death/TV-MI/ID-TLR (Target Lesion Failure (TLF)) | 0.8 percentage of participants |
Secondary
Cardiac Death/TV-MI/ID-TLR (Target Lesion Failure (TLF))
Target Lesion Failure includes Cardiac Death,Target Vessel-Myocardial Infarction and Ischemic Driven-Target Lesion Revascularization. This is one of the Composite Clinical Endpoints (Safety and Efficacy, hierarchical).
Time frame: 0 to 180 Days
Population: Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Absorb Bioresorbable Vascular Scaffold | Cardiac Death/TV-MI/ID-TLR (Target Lesion Failure (TLF)) | 2.1 percentage of participants |
Secondary
Death (Cardiovascular, Non-Cardiovascular)
This is one of the Safety Component (non-hierarchical) endpoints.
Time frame: 0 to 407 days
Population: Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Absorb Bioresorbable Vascular Scaffold | Death (Cardiovascular, Non-Cardiovascular) | 1.0 percentage of participants |
Secondary
Death (Cardiovascular, Non-Cardiovascular)
This is one of the Safety Component (non-hierarchical) endpoints.
Time frame: 0 to 180 days
Population: Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Absorb Bioresorbable Vascular Scaffold | Death (Cardiovascular, Non-Cardiovascular) | 0.7 percentage of participants |
Secondary
Death (Cardiovascular, Non-Cardiovascular)
This is one of the Safety Component (non-hierarchical) endpoints.
Time frame: 0 to 7 days (In-hospital)
Population: Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Absorb Bioresorbable Vascular Scaffold | Death (Cardiovascular, Non-Cardiovascular) | 0.1 percentage of participants |
Secondary
Death (Cardiovascular, Non-Cardiovascular)
This is one of the Safety Component (non-hierarchical) endpoints.
Time frame: 0 to 37 days
Population: Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Absorb Bioresorbable Vascular Scaffold | Death (Cardiovascular, Non-Cardiovascular) | 0.1 percentage of participants |
Secondary
Late Scaffold Thrombosis
Time frame: 31 to 365 Days
Population: Analysis population excludes subjects who are truly lost-to-follow-up, defined as subjects who are terminated through a given time point without any Scaffold Thrombosis event.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Absorb Bioresorbable Vascular Scaffold | Late Scaffold Thrombosis | Definite | 5 percentage of participants |
| Absorb Bioresorbable Vascular Scaffold | Late Scaffold Thrombosis | Probable | 2 percentage of participants |
| Absorb Bioresorbable Vascular Scaffold | Late Scaffold Thrombosis | Definite/Probable | 7 percentage of participants |
Secondary
Major Adverse Cardiac Event (MACE)
MACE includes Cardiac Death, All Myocardial Infarction and Ischemic Driven-Target Lesion Revascularization. This is one of the Composite Clinical Endpoints (Safety and Efficacy, hierarchical).
Time frame: 0 to 180 Days
Population: Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Absorb Bioresorbable Vascular Scaffold | Major Adverse Cardiac Event (MACE) | 2.4 percentage of participants |
Secondary
Major Adverse Cardiac Event (MACE)
MACE includes Cardiac Death, All Myocardial Infarction and Ischemic Driven-Target Lesion Revascularization. This is one of the Composite Clinical Endpoints (Safety and Efficacy, hierarchical).
Time frame: 0 - 37 Days
Population: Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Absorb Bioresorbable Vascular Scaffold | Major Adverse Cardiac Event (MACE) | 1.2 percentage of participants |
Secondary
Major Adverse Cardiac Event (MACE)
MACE includes Cardiac Death, All Myocardial Infarction and Ischemic Driven-Target Lesion Revascularization. This is one of the Composite Clinical Endpoints (Safety and Efficacy, hierarchical).
Time frame: 0 to 407 Days
Population: Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Absorb Bioresorbable Vascular Scaffold | Major Adverse Cardiac Event (MACE) | 3.1 percentage of participants |
Secondary
Major Adverse Cardiac Event (MACE)
MACE includes Cardiac Death, All Myocardial Infarction and Ischemic Driven-Target Lesion Revascularization. This is one of the Composite Clinical Endpoints (Safety and Efficacy, hierarchical).
Time frame: 0 to 7 days (In-hospital)
Population: Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Absorb Bioresorbable Vascular Scaffold | Major Adverse Cardiac Event (MACE) | 0.9 percentage of participants |
Secondary
Subacute ScaffoldThrombosis
Time frame: 1 to 30 days
Population: Analysis population excludes subjects who are truly lost-to-follow-up, defined as subjects who are terminated through a given time point without any Scaffold Thrombosis event.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Absorb Bioresorbable Vascular Scaffold | Subacute ScaffoldThrombosis | Definite | 9 percentage of participants |
| Absorb Bioresorbable Vascular Scaffold | Subacute ScaffoldThrombosis | Probable | 2 percentage of participants |
| Absorb Bioresorbable Vascular Scaffold | Subacute ScaffoldThrombosis | Definite/Probable | 11 percentage of participants |
Secondary
Target Lesion Revascularization : Ischemia-Driven (ID-TLR)
This is one of the Efficacy Component (non-hierarchical) endpoints.
Time frame: 0 to 407 days
Population: Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Absorb Bioresorbable Vascular Scaffold | Target Lesion Revascularization : Ischemia-Driven (ID-TLR) | 1.9 percentage of participants |
Secondary
Target Lesion Revascularization : Ischemia-Driven (ID-TLR)
This is one of the Efficacy Component (non-hierarchical) endpoints.
Time frame: 0 to 37 days
Population: Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Absorb Bioresorbable Vascular Scaffold | Target Lesion Revascularization : Ischemia-Driven (ID-TLR) | 0.6 percentage of participants |
Secondary
Target Lesion Revascularization : Ischemia-Driven (ID-TLR)
This is one of the Efficacy Component (non-hierarchical) endpoints.
Time frame: 0 to 7 days (In-hospital)
Population: Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Absorb Bioresorbable Vascular Scaffold | Target Lesion Revascularization : Ischemia-Driven (ID-TLR) | 0.4 percentage of participants |
Secondary
Target Lesion Revascularization : Ischemia-Driven (ID-TLR)
This is one of the Efficacy Component (non-hierarchical) endpoints.
Time frame: 0 to 180 days
Population: Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Absorb Bioresorbable Vascular Scaffold | Target Lesion Revascularization : Ischemia-Driven (ID-TLR) | 1.3 percentage of participants |
Secondary
Target Lesion Revascularization (TLR): All TLR
This is one of the Efficacy Component (non-hierarchical) endpoints.
Time frame: 0 to 180 days
Population: Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Absorb Bioresorbable Vascular Scaffold | Target Lesion Revascularization (TLR): All TLR | 1.3 percentage of participants |
Secondary
Target Lesion Revascularization (TLR): All TLR
This is one of the Efficacy Component (non-hierarchical) endpoints.
Time frame: 0 to 407 days
Population: Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Absorb Bioresorbable Vascular Scaffold | Target Lesion Revascularization (TLR): All TLR | 2.0 percentage of participants |
Secondary
Target Lesion Revascularization (TLR): All TLR
This is one of the Efficacy Component (non-hierarchical) endpoints.
Time frame: 0 to 7 days (In-hospital)
Population: Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Absorb Bioresorbable Vascular Scaffold | Target Lesion Revascularization (TLR): All TLR | 0.4 percentage of participants |
Secondary
Target Lesion Revascularization (TLR): All TLR
This is one of the Efficacy Component (non-hierarchical) endpoints.
Time frame: 0 to 37 days
Population: Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Absorb Bioresorbable Vascular Scaffold | Target Lesion Revascularization (TLR): All TLR | 0.6 percentage of participants |
Secondary
Target Vessel Revascularization : Ischemic-driven (ID-TVR)
This is one of the Efficacy Component (non-hierarchical) endpoints.
Time frame: 0 to 180 days
Population: Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Absorb Bioresorbable Vascular Scaffold | Target Vessel Revascularization : Ischemic-driven (ID-TVR) | 1.8 percentage of participants |
Secondary
Target Vessel Revascularization : Ischemic-driven (ID-TVR)
This is one of the Efficacy Component (non-hierarchical) endpoints.
Time frame: 0 to 37 days
Population: Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Absorb Bioresorbable Vascular Scaffold | Target Vessel Revascularization : Ischemic-driven (ID-TVR) | 0.8 percentage of participants |
Secondary
Target Vessel Revascularization : Ischemic-driven (ID-TVR)
This is one of the Efficacy Component (non-hierarchical) endpoints.
Time frame: 0 to 407 days
Population: Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Absorb Bioresorbable Vascular Scaffold | Target Vessel Revascularization : Ischemic-driven (ID-TVR) | 2.6 percentage of participants |
Secondary
Target Vessel Revascularization : Ischemic-driven (ID-TVR)
This is one of the Efficacy Component (non-hierarchical) endpoints.
Time frame: 0 to 7 days (In-hospital)
Population: Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Absorb Bioresorbable Vascular Scaffold | Target Vessel Revascularization : Ischemic-driven (ID-TVR) | 0.5 percentage of participants |
Secondary
Target Vessel Revascularization (TVR): All TVR
This is one of the Efficacy Component (non-hierarchical) endpoints.
Time frame: 0 to 407 days
Population: Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Absorb Bioresorbable Vascular Scaffold | Target Vessel Revascularization (TVR): All TVR | 2.9 percentage of participants |
Secondary
Target Vessel Revascularization (TVR): All TVR
This is one of the Efficacy Component (non-hierarchical) endpoints.
Time frame: 0 to 7 days (In-hospital)
Population: Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Absorb Bioresorbable Vascular Scaffold | Target Vessel Revascularization (TVR): All TVR | 0.5 percentage of participants |
Secondary
Target Vessel Revascularization (TVR): All TVR
This is one of the Efficacy Component (non-hierarchical) endpoints.
Time frame: 0 to 37 days
Population: Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Absorb Bioresorbable Vascular Scaffold | Target Vessel Revascularization (TVR): All TVR | 0.8 percentage of participants |
Secondary
Target Vessel Revascularization (TVR): All TVR
This is one of the Efficacy Component (non-hierarchical) endpoints.
Time frame: 0 to 180 days
Population: Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Absorb Bioresorbable Vascular Scaffold | Target Vessel Revascularization (TVR): All TVR | 1.9 percentage of participants |