NCT01392846已完成不适用
Evaluation of Effectiveness and Safety of Resolute Integrity DES in Routine Clinical Practice; A Multicenter Prospective Observational Cohort Study (IRIS-Integrity)
Seung-Jung Park23 个研究点 分布在 1 个国家目标入组 3,000 人开始时间: 2011年7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
- 3,000
- 试验地点
- 23
- 主要终点
- composite of death, nonfatal myocardial infarction (MI), or target- Vessel Revascularization (TVR)
研究概览
简要总结
This is a prospective, observational, cohort study to evaluate the relative efficacy and safety of Resolute Integrity stent compared to other (drug eluting stents) DES.
详细描述
Consecutive Percutaneous Coronary Intervention patients receiving Resolute Integrity stent will be compared with other concurrent Drug Eluting Stents.
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
- •Patients with significant coronary artery disease and receiving Resolute Integrity stent.
- •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 presented with cardiogenic shock
结局指标
主要结局
composite of death, nonfatal myocardial infarction (MI), or target- Vessel Revascularization (TVR)
时间窗: 12 months post procedure
次要结局
- Stroke(12 months and yearly up to 5 years)
- Target-lesion revascularization(12 months and yearly up to 5 years)
- Stent thrombosis(12 months and yearly up to 5 years)
- Procedural success(at day 1)
- Death (all cause and cardiac)(12 months and yearly up to 5 years)
- Myocardial Infarction(12 months and yearly upto 5 years)
- Composite of death or MI(12 months and yearly upto 5 years)
- Composite of cardiac death or MI(12 months and yearly up to 5 years)
- Target Vessel Revascularization(12 months and yearly up to 5 years)
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 (23)
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