NCT00794014已完成不适用
Optimal Strategy for Side Branch Stenting in Coronary Bifurcation Lesion
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 258
- 试验地点
- 1
- 主要终点
- Target vessel failure (TVF)
研究概览
简要总结
The purpose of this study is to establish the optimal strategy for side branch stenting in coronary bifurcation lesion.
详细描述
The purpose of this study is to evaluate the relative efficacy and safety of conservative strategy compared to aggressive strategy for side branch stenting in coronary bifurcation lesion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Parent vessel diameter stenosis > 75%
- •Parent vessel diameter stenosis 50% - 75% with angina and/or objective evidence of ischemia in the non-invasive stress test
- •The reference diameter of both branches more than 2.3 mm by visual estimation
排除标准
- •Cardiogenic shock
- •ST-elevation myocardial infarction within 48 hours of symptom onset
- •Left ventricular dysfunction (echocardiographic left ventricular ejection fraction < 25%)
- •Graft vessels
- •Patients who have to receive clopidogrel due to other conditions
- •Patients who have to receive warfarin, cilostazol or other antiplatelet therapy
- •Hypersensitivity to clopidogrel or aspirin
- •Expectant survival less than 1 year
- •Women who plan to become pregnant
- •Patients with bleeding diathesis (coagulopathy, thrombocytopenia or platelet dysfunction, Gastrointestinal or genitourinary bleeding within the prior 3 months)
- •Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period.
研究组 & 干预措施
Aggressive strategy
Experimental
干预措施: Aggressive strategy (Procedure)
Conservative strategy
Experimental
干预措施: Conservative strategy (Procedure)
结局指标
主要结局
Target vessel failure (TVF)
时间窗: 12 months
composite of cardiac death, myocardial infarction, target vessel revascularization
次要结局
- the incidence of binary angiographic restenosis in the main branch and side branch(9 months)
- Cardiac death(12 months)
- Myocardial infarction (MI)(12 months)
- Target vessel revascularization (TVR)(12 months)
- Target lesion revascularization (TLR)(12 months)
- Stent thrombosis(12 months)
- Periprocedural enzyme elevation(during the hospitalization)
研究者
Hyeon-Cheol Gwon
Professor
Samsung Medical Center
研究点 (1)
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