Evaluation of Effectiveness and Safety of Everolimus-Eluting Stents in Routine Clinical Practice
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 3,000
- 试验地点
- 1
- 主要终点
- Composite of death, nonfatal myocardial infarction (MI), and Target Vessel Revascularization (TVR)
研究概览
简要总结
The objective of this study is to evaluate effectiveness and safety of everolimus-eluting stents (XIENCE, Abbott) in the "real world" daily practice as compared with first-generation drug-eluting stents (sirolimus-eluting stents).
详细描述
This study is a non-randomized, open-label registry to compare the efficacy and safety of everolimus-eluting stents versus sirolimus-eluting stents in patients with coronary artery disease.
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
- •Patients received XIENCE stents
- •The patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethics Committee of the respective clinical site.
排除标准
- •Patients with a mixture of other DESs
- •Terminal illness with life expectancy <1 year.
- •Patients with cardiogenic shock
结局指标
主要结局
Composite of death, nonfatal myocardial infarction (MI), and Target Vessel Revascularization (TVR)
时间窗: at 12 months after PCI
composite of death, nonfatal myocardial infarction (MI), or ischemic driven Target Vessel Revascularization (TVR). Individual events are to be assessed as secondary.
次要结局
- All Death(1month ,6 month and 12 months,2year,3year,4 year and 5year)
- Cardiac death(1month ,6 month and 12 months,2year,3year,4 year and 5year)
- MI(1month ,6 month and 12 months,2year,3year,4 year and 5year)
- Composite of death or MI(1month ,6 month and 12 months,2year,3year,4 year and 5year)
- Composite of cardiac death or MI(1month ,6 month and 12 months,2year,3year,4 year and 5year)
- TVR(1month ,6 month and 12 months,2year,3year,4 year and 5year)
- Target-lesion revascularization (TLR)(1month ,6 month and 12 months,2year,3year,4 year and 5year)
- Stent thrombosis (ARC criteria)(1month ,6 month and 12 months,2year,3year,4 year and 5year)
- Procedural success(at discharge)
研究者
Seung-Jung Park
MD,PhD, Chairman,Heart Institute, Asan Medical Center,University of Ulsan,College of Medicine
CardioVascular Research Foundation, Korea