NCT03103620已完成不适用
Safety And Effectiveness Evaluation Of COBRA PzF™ Coronary Stent System: A French Observational Postmarketing Registry
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,027
- 试验地点
- 15
- 主要终点
- MACE
研究概览
简要总结
A multi-center, prospective, consecutive enrolled, observational registry. The population being studied includes all patients undergoing treatment of "de novo" lesions in native coronary vessels, saphenous vein graft and/or arterial bypass conduits with the COBRA PzF coronary stent system. The registry will primarily assess the rate of MACE (cardiac death, myocardial infarction and clinically driven target lesion revascularization.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Patient has given oral consent to participate in the registry Patient is implanted with a COBRA PzF stent Target lesion(s) is/are "de novo"
排除标准
- •Pregnancy Age <18 years Refusal or inability to give oral consent
结局指标
主要结局
MACE
时间窗: 12 months
Composite clinical endpoint of cardiac death, myocardial infarction, and clinically driven target lesion revascularization
次要结局
- Stent thrombosis(12 months)
- TVR and TLR(12 months)
- DAPT(12 months)
研究者
研究点 (15)
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