A Randomized Comparison of a Biolimus-Eluting Stent With a Sirolimus-Eluting Stent for Percutaneous Coronary Intervention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,707
- 试验地点
- 20
- 主要终点
- Major adverse cardiac events (MACE) in the overall population according to the ARC definitions.
研究概览
简要总结
The purpose of this study is to compare the BioMatrix Flex (Biolimus A9-Eluting) stent system with the Cypher SELECT (Sirolimus-Eluting) stent system in a non-inferiority trial.
详细描述
Compare the safety and efficacy of the BioMatrix Flex (Biolimus A9-Eluting) stent system with the Cypher SELECT (Sirolimus-Eluting) stent system in a prospective, multi-center, randomized, controlled, non-inferiority trial in patients undergoing percutaneous coronary intervention in routine clinical practice.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >= 18 years;
- •Symptomatic coronary artery disease including patients with chronic stable angina, silent ischemia, and acute coronary syndromes including non-ST elevation myocardial infarction and ST-elevation myocardial infarction;
- •Presence of one or more coronary artery stenoses >50% in a native coronary artery or a saphenous bypass graft from 2.25 to 3.5 mm in diameter that can be covered with one or multiple stents;
- •No limitation on the number of treated lesions, and vessels, and lesion length
排除标准
- •Pregnancy;
- •Known intolerance to aspirin, clopidogrel, heparin, stainless steel, Sirolimus, Biolimus or contrast material;
- •Inability to provide informed consent;
- •Currently participating in another trial before reaching first endpoint;
- •Planned surgery within 6 months of PCI unless dual antiplatelet therapy is maintained throughout the perisurgical period
研究组 & 干预措施
BioMatrix Flex stent
Coronary stent placement with Biolimus A9 coated stent with biodegradable polymer
干预措施: Coronary stent placement (Device)
Cypher Select stent
Coronary stent placement with Sirolimus coated stent with durable polymer
干预措施: Coronary stent placement (Device)
结局指标
主要结局
Major adverse cardiac events (MACE) in the overall population according to the ARC definitions.
时间窗: 9 month
Major adverse cardiac events (MACE) in the overall population defined as composite of cardiac death,myocardial infarction (Q-wave and Non-Q wave)justified target vessel revascularization and Justified and non-justified target lesion revascularization (TLR)
次要结局
- Major adverse cardiac events (MACE) in the overall population according to the ARC definitions.(5 year)
- Cardiac death(5 year)
- In-stent and in-segment minimal luminal diameter (MLD) as assessed by QCA.(9 month)
- Angiographic and clinical stent thrombosis.(5 years)
- All deaths(5 years)
- In-stent and in-segment binary restenosis rate as assessed by QCA.(9 month)
- In-stent and in-segment late luminal loss(9 month)
- Myocardial infarction(5 years)
- In-segment percent diameter stenosis (%DS).(9 month)
- Device success, lesion success and procedural success.(at implant)