NCT01348373已完成不适用
Evaluation of Effectiveness and Safety of the GENOUS STENT in ST-Segment Elevation Myocardial Infarction
Seung-Jung Park16 个研究点 分布在 1 个国家目标入组 464 人开始时间: 2010年5月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 464
- 试验地点
- 16
- 主要终点
- composite of death, nonfatal myocardial infarction (MI), or ischemic-driven Target- Vessel Revascularization (TVR)
研究概览
简要总结
The objective of this study is to evaluate effectiveness and safety of GENOUS EPC-coated stent in patients with STEMI with other drug-eluting stents (DESs).
详细描述
This study is a non-randomized, prospective, open-label registry to compare the efficacy and safety of GENOUS stent in STEMI patients with other-type DESs.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •STEMI Patients requiring primary PCI.
- •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), or ischemic-driven Target- Vessel Revascularization (TVR)
时间窗: 12 months post procedure
次要结局
- TVR(yearly up to 5 years)
- Death (all cause and cardiac)(yearly up to 5 years)
- MI(yearly up to 5 years)
- Composite of death or MI(yearly up to 5 years)
- Composite of cardiac death or MI(yearly up to 5 years)
- Target-lesion revascularization (TLR)(6 months)
- Stent thrombosis (ARC criteria)(yearly up to 5 years)
- Procedural success (defined as achievement of a final diameter stenosis of <30% by visual estimation, without the occurrence of death, Q-wave MI, or urgent revascularization during the index hospitalization)(in-hospital)
研究者
Seung-Jung Park
MD,PhD, Chairman,Heart Institute, Asan Medical Center,University of Ulsan,College of Medicine
CardioVascular Research Foundation, Korea
研究点 (16)
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