Absorb GT1 Japan PMS

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

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.

Study Overview

• Status: Completed
• Conditions: Myocardial Ischemia; Coronary Artery Disease; Angina Pectoris; Ischemic Heart Disease; Coronary Artery Occlusion
• Intervention / Treatment: Device: ABSORB GT1 BVS

Detailed Description

The surveillance consists of two phases as detailed below. All patients will be continuously registered in each phases.

Phase 1 (All- patients): Includes 250 patients (approximately 45 sites)

Main Purpose: To confirm the efficacy of physician training and to establish optimal training for increasing medical institutions participating in post-marketing evaluation. Procedural results will be evaluated sequentially for early feedback to the sites. Therefore, there will be no quantitative goal established to move to Phase 2. However, recommended procedure may be updated as required in order to achieve optimal acute result.

Phase 2 (All- patients): Until 2000 patients are registered (up to 200 sites) Main Purpose: To confirm safety.

Target sample size of the Surveillance is approximately 2,000 patients. Commercial sale of Absorb GT1 beyond the purpose of the Surveillance will be started if the scaffold thrombosis (ST) rate in the 2,000 patients at 3 month is 0.9% or lower (ST rates for patients with Absorb GT1).

In the ABSORB III (NCT01751906) clinical trial, 19 events of definite/probable ST reported through 1 year, and 18 of them except 1 occurred within 3 months (maximum of 78 days) post-procedure. Therefore, it is appropriate to perform interim analysis for the safety using ST rate through 3 months. The event occurred after 3 months was reported 362 days after the procedure, and the patient stopped treatment with thienopyridine antiplatelet agent on Day 356.

Both in the AVJ-301 (NCT01844284) and the ABSORB III clinical trials, ST rate through 1 year was 1.5%. In the ABSORB III clinical trial, ST rate in target lesion with Reference Vessel Diameter (RVD) ≥ 2.25 mm was 0.9%. As explained above, ST rates at 3 months and 1 year are almost similar. The half widths of the 95% confidence intervals (CI) to different sample sizes are presented in the table 2.3-1. The half width of 95% CI decreases from 0.6% to 0.4% when a sample size is increased from 1,000 to 2,000. However, further increase in the sample size does not result in significant decrease in the half width of 95% CI. Therefore, the sample size of the Surveillance was established as 2,000 patients.

• Study Type: Interventional
• Enrollment (Actual): 135
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Japan
  • Kumamoto, Japan, 861-4193
    • Saiseikai Kumamoto Hospital
  • Miyazaki, Japan, 880-0834
    • Miyazaki Medical Association Hospital
  • Osaka, Japan, 530-0001
    • Sakurabashi Watanabe Hospital
  • Aichi
    • Nagoya, Aichi, Japan, 466-8650
      • Nagoya Daini Red Cross Hospital
  • Chiba
    • Matsudo, Chiba, Japan, 270-2232
      • Shin Tokyo Hospital
  • Fukuoka
    • Kurume, Fukuoka, Japan, 830-8577
      • Shin Koga Hospital
  • Hokkaido
    • Sapporo, Hokkaido, Japan, 062-0003
      • Hanaoka Seishu Memorial Cardiovascular Clinic
  • Hyogo
    • Kobe, Hyogo, Japan, 650-0017
      • Kobe University
  • Iwate
    • Morioka, Iwate, Japan, 020-8505
      • Iwate Medical University
  • Kanagawa
    • Kamakura, Kanagawa, Japan, 247-8533
      • Shonan Kamakura General Hospital
  • Okayama
    • Kurashiki, Okayama, Japan, 710-8602
      • Kurashiki Central Hospital
  • Saitama
    • Sayama, Saitama, Japan, 350-1323
      • Saitama Sekishinkai Hospital
  • Tokyo
    • Chiyoda, Tokyo, Japan, 101-8643
      • Mitsui Memorial Museum
    • Itabashi, Tokyo, Japan, 173-8606
      • Teikyo University
    • Meguro, Tokyo, Japan, 153-8515
      • Toho University Ohashi Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• General Percutaneous coronary intervention (PCI) population.

Exclusion Criteria:

• No specific exclusion criteria.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Absorb GT1 BVS; Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System.	Device: ABSORB GT1 BVS; Patients receiving Absorb GT1 BVS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Cumulative Scaffold Thrombosis	Criteria: ST rate (in 2,000 patients: sum of Phase 1 and Phase2), Success Criteria: ST rate at 3 months is ≤ 18 patients (0.9%). Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis: 0 - 24 hours post stent implantation; Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation; Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation; Very late scaffold/stent thrombosis: >1 year post stent implantation.	0 - 1825 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 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 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 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).	5 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 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 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.	5 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.	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 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 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 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 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
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.	5 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)	5 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.	5 years
Number of Death/MI/All Revascularization (DMR)	DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.	5 years
Number of Major Adverse Cardiac Event (MACE)	MACE is the composite of Cardiac death/All myocardial infarction (MI)/ Ischemia-driven Revascularization (ID-TLR).	5 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).	5 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.	5 years

Collaborators and Investigators

• Sponsor: Abbott Medical Devices
• Investigators: Principal Investigator: Masato Nakamura, MD, Toho University Ohashi Medical Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 13, 2016
• Primary Completion (Actual): February 6, 2023
• Study Completion (Actual): February 6, 2023

Study Registration Dates

• First Submitted: May 18, 2017
• First Submitted That Met QC Criteria: January 18, 2018
• First Posted (Actual): January 24, 2018

Study Record Updates

• Last Update Posted (Actual): August 6, 2024
• Last Update Submitted That Met QC Criteria: July 10, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Real world; Drug eluting Bio-resolvable Scaffold (BRS); Bio-resolvable Scaffold (BRS)
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Pain; Neurologic Manifestations; Coronary Disease; Chest Pain; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Angina Pectoris; Coronary Occlusion
• Other Study ID Numbers: 16-310

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes