NCT06177743招募中不适用
Evaluation of Effectiveness and Safety of Coroflex ISAR NEO Stent in Routine Clinical Practice; A Multicenter, Prospective Observational Study
Seung-Jung Park22 个研究点 分布在 2 个国家目标入组 1,000 人开始时间: 2025年1月9日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,000
- 试验地点
- 22
- 主要终点
- the 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 the effectiveness and safety of Coroflex ISAR NEO stents in comparison to other drug-eluting stents (DES) in real-world practice.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients ≥ 19 years old
- •Patients receiving Coroflex ISAR NEO 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
the composite of death, nonfatal myocardial infarction (MI), or ischemic-driven Target- Vessel Revascularization (TVR)
时间窗: 12 months
the composite of death, nonfatal myocardial infarction (MI), or ischemic-driven Target- Vessel Revascularization (TVR) at 12 months post procedure. A composite endpoint is an endpoint that is a combination of multiple clinical endpoints. An event is considered to have occurred if any one of several different events is observed.
次要结局
- the event rate of all cause death(5 years)
- the event rate of cardiac death(5 years)
- the event rate of myocardial infarction(5 years)
- the composite event rate of death, or myocardial infarction (MI)(5 years)
- the composite event rate of cardiac death, or myocardial infarction (MI)(5 years)
- the event rate of Target- Vessel Revascularization (TVR)(5 years)
- the event rate of Target- lesion Revascularization (TLR)(5 years)
- the event rate of stent thrombosis(5 years)
- the event rate of stroke(5 years)
- the event rate of Procedural success(5 days)
研究者
Seung-Jung Park
professor
Asan Medical Center
研究点 (22)
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相似试验
Unknown
4 期
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