NCT01348360已完成不适用
Evaluation of Effectiveness and Safety of NOBORI Stent in Routine Clinical Practice; A Multicenter, Prospective, Observational Study
Seung-Jung Park25 个研究点 分布在 1 个国家目标入组 2,000 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
- 2,000
- 试验地点
- 25
- 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 Nobori stent in the "real world" daily practice as compared with first-generation drug-eluting stents (sirolimus- or paclitaxel-eluting stents).
详细描述
This study is a non-randomized, prospective, open-label registry to compare the efficacy and safety of NOBORI stents versus first-generation DES 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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients receiving NOBORI 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), or ischemic-driven Target- Vessel Revascularization (TVR)
时间窗: 12 months post procedure
次要结局
- Death (all cause and cardiac)(yearly up to 5 years)
- MI(yearly up to 5 years)
- TVR(yearly up to 5 years)
- Target-lesion revascularization (TLR)(yearly up to 5 years)
- Stent thrombosis (ARC criteria)(yearly up to 5 years)
- Composite of death or MI(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)(At discharge from the index hospitalization)
- Composite of cardiac death or MI(yearly and up to 5 years)
研究者
Seung-Jung Park
MD, PhD
CardioVascular Research Foundation, Korea
研究点 (25)
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