NCT02708329已完成不适用
Results of T-provisional and Mini Crush Stenting in Patients With Bifurcation Lesions After Chronic Coronary Arteries Occlusions Recanalization: A Prospective Randomized Single-center Study.
Meshalkin Research Institute of Pathology of Circulation2 个研究点 分布在 1 个国家目标入组 146 人开始时间: 2011年1月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 146
- 试验地点
- 2
- 主要终点
- Target lesion failure
研究概览
简要总结
The aim is to compare the results of using T-provisional and Mini-Crush stenting techniques in patients with bifurcation lesions in the CTO segment.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients considered for coronary angioplasty with stenting due to Ischemic heart disease (Stable angina, Unstable angina, non-ST Myocardial Infarction).
- •Bifurcation side branch diameter >2 mm in CTO segment, verified by coronary angiography
- •Successful CTO recanalization
- •Signed, documented informed consent prior to admission to the study
排除标准
- •Age <18 years or >75 years
- •Left main artery bifurcation lesion
- •Reocclusion CTOs
- •Renal insufficiency (GFR/MDRD <30 ml/min)
- •Subject has a platelet count < 100,000 cells/mm3 or > 700,000 cells/mm
- •Known non-adherence to double anti-platelet therapy (DAPT)
- •LVEF <30%
- •Continuing bleeding
- •Acute coronary syndrome (ST-elevation Myocardial infarction)
- •Anamnesis of previous CABG
- •Pregnancy
结局指标
主要结局
Target lesion failure
时间窗: During 1 year after procedure
Primary outcome is defined as a composite endpoint of cardiac death, target vessel myocardial infarction and clinically indicated target lesion revascularization.
次要结局
- Major adverse cardiac and cerebrovascular events (MACCE)(During 1 year after procedure)
- Restenosis of main vessel/side branch(At 12-month follow-up)
研究者
研究点 (2)
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