Safety and Efficacy of Polymer-free Sirolimus-eluting Coronary Stents in Patients With Coronary Artery Disease.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 2,500
- 试验地点
- 1
- 主要终点
- target lesion failure (TLF)
研究概览
简要总结
The study aims to evaluate the safety and efficacy of polymer-free sirolimus-eluting coronary stent system (NANO plus) in patients with coronary artery disease . The primary endpoint is target lesion failure, a composite endpoint of cardiac death, target vessel related myocardial infarction and clinically-driven target lesion revascularization at 1 year follow-up.
详细描述
This is a prospective, multicenter, single arm clinical registry investigating the safety and efficacy of polymer-free sirolimus-eluting coronary stent system (NANO plus) in patients with coronary artery disease . In total, we plan to recruit 2500 patients in real world setting. The patients will be followed clinically at 1-, 6- month and 1-, 2-, 3-, 4-, 5-year. All clinical data will be collected and managed by statistical center, clinical endpoint adjudication committee.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-85 years old, male or non-pregnancy female;
- •Patients with coronary artery disease who match the indication of stent implantation;
- •Patients who can understand the nature of the study, agree to participate and accept clinical follow-up;
排除标准
- •Patients who can not tolerate the material or medication in this study;
- •Pregnancy or lactation women
- •Patients who had participated in another investigational drug or device trial that has not completed the primary endpoint;
- •Patients are, in the opinion of the investigator, unable to comply with the requirements of the study protocol
结局指标
主要结局
target lesion failure (TLF)
时间窗: 12 months
cardiac death, target vessel related myocardial infarction and/or clinically driven target lesion revascularization
次要结局
- cardiac death(1、6、12、24、36、48、60 months)
- Patient oriented composite endpoint(1、6、12、24、36、48、60 months)
- Target lesion failure(1、6、12、24、36、48、60 months)
- Target vessel revascularization(1、6、12、24、36、48、60 months)
- target lesion failure(1、6、24、36、48、60 months)
- all cause death(1、6、12、24、36、48、60 months)
- Myocardial infarction(1、6、12、24、36、48、60 months)
- Stent thrombosis(1、6、12、24、36、48、60 months)
- Target lesion revascularization(1、6、12、24、36、48、60 months)
研究者
Tao Ling
Professor
Xijing Hospital