NCT01289002已完成不适用
A Postmarket Registry of the BioMatrix™ and BioMatrix Flex™ Drug Eluting Stents.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 5,652
- 试验地点
- 69
- 主要终点
- MACE
研究概览
简要总结
The purpose of this registry is to capture clinical data of the BioMatrix™ and BioMatrix Flex™ (Biolimus A9™-Eluting) stent systems in relation to safety and effectiveness.
详细描述
Prospective, multi-center registry to be conducted at 60-70 international interventional cardiology centers. All patients will be followed for up to 3 years.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patients that need a treatment with either a BioMatrix™ or a BioMatrix Flex™ drug-eluting stent
- •Presence of one or more coronary artery stenoses in a native coronary artery or a saphenous bypass graft from 2.25 to 4.0 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
- •Inability to provide informed consent
- •Patients needing additional stent NOT of the Biolimus A9™-eluting stent type
- •Patients receiving next to the Biolimus A9™-eluting stent also other coronary vascular interventions, for example dilation
- •Patients receiving both the BioMatrix™ and the BioMatrix Flex™ stent during index and/or staged procedure
结局指标
主要结局
MACE
时间窗: 12 months
Major adverse cardiac events (MACE) in the overall population, defined as composite of cardiac death, myocardial infarction (Q-wave and non-Q-wave), or justified target vessel revascularization at 12 months.
次要结局
- MACE(30 days, 6 months, 2, 3 and 5 years;)
- Death and MI at 30 days, 6 and 12 months, 2, 3 and 5 years;(30 days, 6 and 12 months, 2, 3 and 5 years;)
- stent thrombosis(30 days, 6 and 12 months, 2, 3 and 5 years)
- Total revascularization rate (clinically and non clinically driven) at 30 days, 6 and 12 months, 2, 3 and 5 years.(30 days, 6 and 12 months, 2, 3 and 5 years.)
- Patient Oriented Composite Endpoint defined as any cause mortality, MI (Q-wave and non-Q-wave), or any clinically driven target vessel revascularization at 30 days, 6 and 12 months, 2, 3 and 5 years;(6 and 12 months, 2, 3 and 5 years)
- Death and post-procedural MI at 30 days, 6 and 12 months, 2, 3 and 5 years;(30 days, 6 and 12 months, 2, 3 and 5 years)
研究者
研究点 (69)
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