Absorb GT1 Japan PMS

Study Overview
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Brief Summary
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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.

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

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

Intervention / Treatment
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* Device: ABSORB GT1 BVS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: General Percutaneous coronary intervention (PCI) population. Exclusion Criteria: No specific exclusion criteria.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Absorb GT1 BVS<br>Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System. | Device: ABSORB GT1 BVS<br>* Patients receiving Absorb GT1 BVS<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Day 0 | 
| 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 | >1 to 30 days | 
| 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 | 31 to 90 days | 
| 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 | 31 to 365 days | 
| 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 | 366 to 730 days | 
| 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 | 0 to 90 days | 
| 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 | 0 to 90 days | 
| 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 | 0 to 730 days | 
| 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. | During index procedure, 54.8 ± 27.6 min | 
| 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. | During index procedure, 54.8 ± 27.6 min | 
| Number of Participants With Composite of Device Deficiencies | Device deficiencies: Number of participants with at least one of the following Device deficiencies Lesion/implant failure Delivery difficulty (finally delivered) Re-crossing failure Re-crossing difficulty Post-dilatation balloon Optical Coherence Tomography (OCT)/Intravascular Ultrasound (IVUS) Instruction for Use (IFU) not included Major Strut Malapposition Strut Fracture within 6 months | During index procedure, 54.8 ± 27.6 min | 
| 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. | 731 - 1095 days | 
| 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 | 0 - 1095 days | 
| 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 | 1096 - 1460 days | 
| 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 | 0 - 1460 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 0 to 30 days | 
| 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. | 0 to 90 days | 
| 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. | 0 to 1 year | 
| 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. | 0 to 2 years | 
| 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) | 0 to 30 days | 
| 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) | 0 to 90 days | 
| 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) | 0 to 1 year | 
| 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) | 0 to 2 years | 
| 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. | 0 to 30 days | 
| 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. | 0 to 90 days | 
| 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. | 0 to 1 year | 
| 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. | 0 to 2 years | 
| 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. | 0 to 30 days | 
| 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. | 0 to 90 days | 
| 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. | 0 to 1 year | 
| 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. | 0 to 2 years | 
| Number of Participants With All Coronary Revascularization | All coronary revascularization is a composite of coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI) | 0 to 30 days | 
| Number of Participants With All Coronary Revascularization | All coronary revascularization is a composite of coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI) | 0 to 90 days | 
| Number of Participants With All Coronary Revascularization | All coronary revascularization is a composite of coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI) | 0 to 1 year | 
| Number of Participants With All Coronary Revascularization | All coronary revascularization is a composite of coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI) | 0 to 2 years | 
| Number of Death/MI/All Revascularization (DMR) | DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization | 0 to 30 days | 
| Number of Death/MI/All Revascularization (DMR) | DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization | 0 to 90 days | 
| Number of Death/MI/All Revascularization (DMR) | DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization | 0 to 1 year | 
| Number of Death/MI/All Revascularization (DMR) | DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization | 0 to 2 years | 
| 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). | 0 to 30 days | 
| 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). | 0 to 90 days | 
| 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) | 0 to 1 Year | 
| 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) | 0 to 2 years | 
| Number of Major Adverse Cardiac Event (MACE) | MACE is the composite of Cardiac death/All myocardial infarction (MI)/ Ischemia-driven Revascularization (ID-TLR) | 0 to 30 days | 
| Number of Major Adverse Cardiac Event (MACE) | MACE is the composite of Cardiac death/All myocardial infarction (MI)/ Ischemia-driven Revascularization (ID-TLR) | 0 to 90 days | 
| Number of Major Adverse Cardiac Event (MACE) | MACE is the composite of Cardiac death/All myocardial infarction (MI)/ Ischemia-driven Revascularization (ID-TLR) | 0 to 1 year | 
| Number of Major Adverse Cardiac Event (MACE) | MACE is the composite of Cardiac death/All myocardial infarction (MI)/ Ischemia-driven Revascularization (ID-TLR) | 0 to 2 years | 
| 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). | 0 to 30 days | 
| 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). | 0 to 90 days | 
| 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). | 0 to 1 year | 
| 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). | 0 to 2 years | 
| 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. | 0 to 30 days | 
| 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. | 0 to 90 days | 
| 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. | 0 to 1 year | 
| 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. | 0 to 2 years | 
| Angiographic Endpoints (Core Lab Analysis): Lesion Morphology |  | Pre-procedure | 
| 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 | Pre-procedure | 
| Angiographic Endpoints (Core Lab Analysis): Lesion Length | Lesion Length (can be measured after successful post-dilatation) | Pre-procedure | 
| Angiographic Endpoints (Core Lab Analysis): Proximal Reference Vessel Diameter (RVD) | Proximal RVD (can be measured after successful post-dilatation) | Pre-procedure | 
| Angiographic Endpoints (Core Lab Analysis): Distal RVD | Distal RVD (can be measured after successful post-dilatation) | Pre-procedure | 
| 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 | Pre-procedure | 
| 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). | Pre-procedure | 
| 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 | Post-procedure (average procedure time of 54.8 ± 27.6 min) | 
| 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. | Post-procedure (average procedure time of 54.8 ± 27.6 min) | 
| 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. | Post-procedure (average procedure time of 54.8 ± 27.6 min) | 
| 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). | Post-procedure (average procedure time of 54.8 ± 27.6 min) | 
| 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): Lumen Diameter or Lumen Area (Proximal/Distal) |  | Post-procedure (average procedure time of 54.8 ± 27.6 min) | 
| IVUS/OCT Endpoints (Core Lab Analysis): Minimal Lumen Area |  | Post-procedure (average procedure time of 54.8 ± 27.6 min) | 
| 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 | Post-procedure (average procedure time of 54.8 ± 27.6 min) | 
| IVUS/OCT Endpoints (Core Lab Analysis): Percentage of Strut Fracture | Strut fracture will be measured as either number or percentage post-procedure | Post-procedure (average procedure time of 54.8 ± 27.6 min) | 
| 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. | 3 years | 
| 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) | 3 years | 
| 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. | 3 years | 
| 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. | 3 years | 
| Number of Participants With All Coronary Revascularization | All coronary revascularization is a composite of coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI) | 3 years | 
| Number of Death/MI/All Revascularization (DMR) | DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization | 3 years | 
| 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). | 3 years | 
| Number of Major Adverse Cardiac Event (MACE) | MACE is the composite of Cardiac death/All myocardial infarction (MI)/ Ischemia-driven Revascularization (ID-TLR) | 3 years | 
| 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). | 3 years | 
| 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. | 3 years | 
| 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. | 4 years | 
| 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) | 4 years | 
| 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. | 4 years | 
| 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. | 4 years | 
| Number of Participants With All Coronary Revascularization | All coronary revascularization is a composite of coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI) | 4 years | 
| Number of Death/MI/All Revascularization (DMR) | DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization | 4 years | 
| 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). | 4 years | 
| Number of Major Adverse Cardiac Event (MACE) | MACE is the composite of Cardiac death/All myocardial infarction (MI)/ Ischemia-driven Revascularization (ID-TLR) | 4 years | 
| 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). | 4 years | 
| 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. | 4 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Drug eluting Bio-resolvable Scaffold (BRS), Bio-resolvable Scaffold (BRS), Real world