Absorb GT1 Japan PMS

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03409731
• Other study ID #: 16-310
• Status: Completed
• Phase: N/A
• Start date: December 13, 2016
• Est. completion date: February 6, 2023

Study information

• Verified date: July 2023
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 135
• Est. completion date: February 6, 2023
• Est. primary completion date: February 6, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• General Percutaneous coronary intervention (PCI) population.

Exclusion Criteria:

• No specific exclusion criteria.

Related Conditions & MeSH terms

• Angina Pectoris
• Coronary Artery Disease
• Coronary Artery Occlusion
• Coronary Occlusion
• Heart Diseases
• Ischemia
• Ischemic Heart Disease
• Myocardial Ischemia

Intervention

Device:
• ABSORB GT1 BVS
Patients receiving Absorb GT1 BVS

Locations

Country	Name	City	State
Japan	Mitsui Memorial Museum	Chiyoda	Tokyo
Japan	Teikyo University	Itabashi	Tokyo
Japan	Shonan Kamakura General Hospital	Kamakura	Kanagawa
Japan	Kobe University	Kobe	Hyogo
Japan	Saiseikai Kumamoto Hospital	Kumamoto
Japan	Kurashiki Central Hospital	Kurashiki	Okayama
Japan	Shin Koga Hospital	Kurume	Fukuoka
Japan	Shin Tokyo Hospital	Matsudo	Chiba
Japan	Toho University Ohashi Medical Center	Meguro	Tokyo
Japan	Miyazaki Medical Association Hospital	Miyazaki
Japan	Iwate Medical University	Morioka	Iwate
Japan	Nagoya Daini Red Cross Hospital	Nagoya	Aichi
Japan	Sakurabashi Watanabe Hospital	Osaka
Japan	Hanaoka Seishu Memorial Cardiovascular Clinic	Sapporo	Hokkaido
Japan	Saitama Sekishinkai Hospital	Sayama	Saitama

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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	Day 0
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	>1 to 30 days
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	31 to 90 days
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	31 to 365 days
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	366 to 730 days
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	0 to 90 days
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	0 to 90 days
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	0 to 730 days
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.	During index procedure, "54.8 ± 27.6 min"
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.	During index procedure, "54.8 ± 27.6 min"
Primary	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"
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.	731 - 1095 days
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	0 - 1095 days
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	1096 - 1460 days
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	0 - 1460 days
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.	0 to 30 days
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.	0 to 90 days
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.	0 to 1 year
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.	0 to 2 years
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)	0 to 30 days
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)	0 to 90 days
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)	0 to 1 year
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)	0 to 2 years
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.	0 to 30 days
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.	0 to 90 days
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.	0 to 1 year
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.	0 to 2 years
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.	0 to 30 days
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.	0 to 90 days
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.	0 to 1 year
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.	0 to 2 years
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)	0 to 30 days
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)	0 to 90 days
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)	0 to 1 year
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)	0 to 2 years
Secondary	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
Secondary	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
Secondary	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
Secondary	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
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).	0 to 30 days
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).	0 to 90 days
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)	0 to 1 Year
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)	0 to 2 years
Secondary	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
Secondary	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
Secondary	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
Secondary	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
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).	0 to 30 days
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).	0 to 90 days
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).	0 to 1 year
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).	0 to 2 years
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.	0 to 30 days
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.	0 to 90 days
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.	0 to 1 year
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.	0 to 2 years
Secondary	Angiographic Endpoints (Core Lab Analysis): Lesion Morphology		Pre-procedure
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	Pre-procedure
Secondary	Angiographic Endpoints (Core Lab Analysis): Lesion Length	Lesion Length (can be measured after successful post-dilatation)	Pre-procedure
Secondary	Angiographic Endpoints (Core Lab Analysis): Proximal Reference Vessel Diameter (RVD)	Proximal RVD (can be measured after successful post-dilatation)	Pre-procedure
Secondary	Angiographic Endpoints (Core Lab Analysis): Distal RVD	Distal RVD (can be measured after successful post-dilatation)	Pre-procedure
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	Pre-procedure
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).	Pre-procedure
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	Post-procedure (average procedure time of "54.8 ± 27.6 min")
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.	Post-procedure (average procedure time of "54.8 ± 27.6 min")
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.	Post-procedure (average procedure time of "54.8 ± 27.6 min")
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).	Post-procedure (average procedure time of "54.8 ± 27.6 min")
Secondary	IVUS/OCT Endpoints (Core Lab Analysis): Lumen Diameter or Lumen Area (Proximal/Distal)		Pre-procedure (or after pre-dilatation)
Secondary	IVUS/OCT Endpoints (Core Lab Analysis): Lumen Diameter or Lumen Area (Proximal/Distal)		Post-procedure (average procedure time of "54.8 ± 27.6 min")
Secondary	IVUS/OCT Endpoints (Core Lab Analysis): Minimal Lumen Area		Post-procedure (average procedure time of "54.8 ± 27.6 min")
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	Post-procedure (average procedure time of "54.8 ± 27.6 min")
Secondary	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")
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.	3 years
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)	3 years
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.	3 years
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.	3 years
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)	3 years
Secondary	Number of Death/MI/All Revascularization (DMR)	DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization	3 years
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).	3 years
Secondary	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
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).	3 years
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.	3 years
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.	4 years
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)	4 years
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.	4 years
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.	4 years
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)	4 years
Secondary	Number of Death/MI/All Revascularization (DMR)	DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization	4 years
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).	4 years
Secondary	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
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).	4 years
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.	4 years