A French Post-market Observational/Non-interventional Study of the BioMatrix Flex™ and BioMatrix Neo Flex™ Drug Eluting Stents With 6-month DAPT
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,098
- 主要终点
- Major adverse cardiac and cerebrovascular events (MACCE) in the overall population, defined as composite of all-cause death, cerebrovascular accidents, non fatal myocardial infarction or clinically-driven target vessel revascularization at 6 months
研究概览
简要总结
Prospective, multi-center observational study to be conducted in up to 30 French interventional cardiology centers. The purpose of this observational study is to capture, in French Centers, clinical data of the BioMatrix Flex™ and BioMatrix NeoFlex™ Drug Eluting Coronary Stents System (Biolimus A9, BA9™-) in normal practice, in patients treated with 6-month DAPT, and to compare the outcomes to those of previous e-biomatrix registries with longer DAPT durations. The patients will be followed up for 2 years for data collection.
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
- •"Real world, all comer" patients
- •Age ≥18 years;
- •Patients that need a treatment with a BioMatrix Flex™ drug- eluting stent or a BioMatrix NeoFlex™drug-eluting stent;
- •Presence of one or more coronary artery stenoses in a native coronary artery 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, vessels, and lesion length, within the limits of social security reimbursements;
- •Patient with DAPT indication after PCI.
排除标准
- •Inability to provide informed consent;
- •Patients needing additional stent NOT of the BioMatrix Flex™ or NeoFlex™ types;
- •Patients receiving next to the BioMatrix Flex™ or BioMatrix NeoFlex™ also other coronary vascular interventions, for example, balloon dilation;
- •Pregnant or planning to become pregnant patient;
- •DES and BMS implantation less than 6 months before screening;
结局指标
主要结局
Major adverse cardiac and cerebrovascular events (MACCE) in the overall population, defined as composite of all-cause death, cerebrovascular accidents, non fatal myocardial infarction or clinically-driven target vessel revascularization at 6 months
时间窗: 6 months
Major adverse cardiac and cerebrovascular events (MACCE) in the overall population, defined as composite of all-cause death, cerebrovascular accidents, non fatal myocardial infarction or clinically-driven target vessel revascularization at 6 months
次要结局
- Cardiac deaths at 6 months and and 2 years(6 months and and 2 years)
- Death,MI and cerebrovascular accidents at 6 months and 2 years(6 months and 2 years)
- Major adverse cardiac and cerebrovascular events (MACCEs) in the overall population(2 years)
- Primary and secondary stent thrombosis(6 months and 2 years)
- Major bleeding(6 months and 2 years)
- Patient Oriented Composite Endpoint defined as any cause mortality, MI (Q-wave and non-Q-wave), or any revascularization at 6 months and 2 years(6 months and 2 years)
- Death, post-procedural MI and cerebrovascular accidents at 6 months and 2 years(6 months and 2 years)