A retrospective, single-arm, multi-center, observational, post-market clinical follow-up study to evaluate the safety and performance of FlexyRap Cobalt Chromium Rapamycin Eluting CoronaryStent System in patients with de novo coronary artery disease under real-world settings.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 500
- 试验地点
- 5
- 主要终点
- Target Lesion Failure which is defined as a composite of cardiovascular death, target vessel myocardial
研究概览
简要总结
A retrospective, single-arm, multi-center, observational, post-market clinical follow-up study to evaluate the safety and performance of FlexyRap Cobalt Chromium Rapamycin Eluting Coronary Stent System in patients with de novo coronary artery disease under real-world settings. The clinical endpoints are target lesion failure, cardiovascular death, target vessel myocardial infarction, clinically-driven target lesion revascularisation (CD-TLR), stent thrombosis (ST), target vessel failure (TVF), target vessel revascularization at 12 months, 3 years, 5 years follow-up. Total Number of 500 patients will be enrolled who have been implanted with FlexyRap Cobalt Chromium Rapamycin Eluting Coronary Stent .
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •All patients implanted with FlexyRap Cobalt Chromium Rapamycin Eluting Coronary Stent System.
排除标准
- •Patients who are not implanted with FlexyRap Cobalt Chromium Rapamycin Eluting Coronary Stent System.
结局指标
主要结局
Target Lesion Failure which is defined as a composite of cardiovascular death, target vessel myocardial
时间窗: 12 Months
infarction (TV-MI) and clinically driven target lesion revascularization
时间窗: 12 Months
次要结局
- Cardiovascular Death(Target Vessel Myocardial Infarction)