NCT05488665招募中不适用
The COMPLETE Treatment of Bifurcation With Two-stent Techniques: Randomized Comparison of Crush Versus Culotte Technique
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 512
- 试验地点
- 1
- 主要终点
- Target lesion failure
研究概览
简要总结
In this COMPLETE randomized trial, using the contemporary second-generation drug-eluting stent, we aimed to test whether the crush technique is superior to the culotte technique for the treatment of bifurcation lesions in terms of 1-year target-lesion failure.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥19 years
- •De novo coronary lesions eligible for drug-eluting stent implantation
- •Medina 1,1,1 or 1,0,1 or 0,1,1 de novo bifurcation lesions (LM or non-LM) and those of main vessel or side branch can be covered by 2 stents
- •Reference vessel diameter of side branch ≥2.5 mm by visual estimation
排除标准
- •Current or potential pregnancy
- •Inability to follow the patient over the period of 1 year after enrollment, as assessed by the investigator
- •Subjects with ST elevation myocardial infarction <24 h from the onset of chest pain
- •Cardiogenic Shock
研究组 & 干预措施
Crush technique group
Experimental
Two stenting with the Crush technique
干预措施: Crush technique (Device)
Culotte technique group
Active Comparator
Two stenting with the Culotte technique
干预措施: Culotte technique (Device)
结局指标
主要结局
Target lesion failure
时间窗: 1 year
The composite of cardiovascular death, target vessel myocardial infarction or clinically driven target lesion revascularization
次要结局
- Target-vessel or non-target vessel myocardial infarction(1 year)
- Clinically driven target-lesion revascularization(1 year)
- Cardiovascular death(1 year)
- Target vessel myocardial infarction(1 year)
- All-cause of death(1 year)
- Definite or probable stent thrombosis(1 year)
研究者
研究点 (1)
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