Absorb GT1 Bioresorbable Vascular Scaffold (BVS) System Post-marketing Surveillance (PMS)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 135
- 试验地点
- 30
- 主要终点
- Number of Participants With Acute Scaffold Thrombosis (ST)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •General Percutaneous coronary intervention (PCI) population.
排除标准
- •No specific exclusion criteria.
结局指标
主要结局
Number of Participants With Acute Scaffold Thrombosis (ST)
时间窗: Day 0
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.
Number of Participants With Composite of Device Deficiencies
时间窗: During index procedure, "54.8 ± 27.6 min"
Device deficiencies: Number of participants with at least one of the following Device deficiencies 1. Lesion/implant failure 2. Delivery difficulty (finally delivered) 3. Re-crossing failure 4. Re-crossing difficulty 5. Post-dilatation balloon 6. Optical Coherence Tomography (OCT)/Intravascular Ultrasound (IVUS) 7. Instruction for Use (IFU) not included 8. Major Strut Malapposition 9. Strut Fracture within 6 months
Number of Participants With Late Scaffold Thrombosis (ST)
时间窗: 731 - 1095 days
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.
Number of Participants With Sub Acute Scaffold Thrombosis (ST)
时间窗: >1 to 30 days
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.
Number of Participants With Very Late Scaffold Thrombosis (ST)
时间窗: 1096 - 1460 days
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
Number of Participants With Overall Scaffold Thrombosis (ST)
时间窗: 0 to 90 days
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
Number of Participants With Cumulative Scaffold Thrombosis
时间窗: 0 - 1825 days
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.
Number of Participants With Exclusion of Very Small Vessels
时间窗: During index procedure, "54.8 ± 27.6 min"
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.
Number of Participants With Scaffold Apposition Assessed by Intravascular Imaging
时间窗: During index procedure, "54.8 ± 27.6 min"
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.
次要结局
- Number of Participants With All Myocardial Infarction (MI)(5 years)
- Number of Participants With All Target Vessel Revascularization (TVR)(5 years)
- Number of Participants With Target Vessel Failure (TVF)(5 years)
- Angiographic Endpoints (Core Lab Analysis): Lesion Morphology(Pre-procedure)
- Number of Participants With All Coronary Revascularization(4 years)
- Number of Major Adverse Cardiac Event (MACE)(5 years)
- Angiographic Endpoints (Core Lab Analysis): Lesion Length(Pre-procedure)
- Number of All Death (Cardiac, Vascular, Non-Cardiovascular)(5 years)
- Number of Cardiac Death/TV-MI/ID-TLR (TLF)(5 years)
- Angiographic Endpoints (Core Lab Analysis):Thrombolysis in Myocardial Infarction (TIMI) Blood Flow(Pre-procedure)
- Angiographic Endpoints (Core Lab Analysis): %DS (In-Segment )(Post-procedure (average procedure time of "54.8 ± 27.6 min"))
- Angiographic Endpoints (Core Lab Analysis): Thrombolysis in Myocardial Infarction (TIMI) Blood Flow(Post-procedure (average procedure time of "54.8 ± 27.6 min"))
- IVUS/OCT Endpoints (Core Lab Analysis): Percentage of Lesions With Strut Malapposition(Post-procedure (average procedure time of "54.8 ± 27.6 min"))
- 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 Strut Fracture(Post-procedure (average procedure time of "54.8 ± 27.6 min"))
- Number of Participants With All Target Lesion Revascularization (TLR)(5 years)
- Number of Death/MI/All Revascularization (DMR)(5 years)
- Angiographic Endpoints (Core Lab Analysis): Proximal Reference Vessel Diameter (RVD)(Pre-procedure)
- Angiographic Endpoints (Core Lab Analysis): Minimum Lumen Diameter (MLD)(Pre-procedure)
- Angiographic Endpoints (Core Lab Analysis): MLD (In-segment)(Post-procedure (average procedure time of "54.8 ± 27.6 min"))
- Number of Participants With Cardiac Death/Myocardial Infarction (MI)(5 years)
- Angiographic Endpoints (Core Lab Analysis): Distal RVD(Pre-procedure)
- Angiographic Endpoints (Core Lab Analysis): Percent Diameter Stenosis (%DS)(Pre-procedure)
- Angiographic Endpoints (Core Lab Analysis): Acute Gain (In-Segment )(Post-procedure (average procedure time of "54.8 ± 27.6 min"))