NCT00916695Unknown4 期
Everolimus-Eluting Stent in the Treatment of Bifurcation Lesions: Comparison of Main Vessel Stent to Main Vessel and Side Branch Stent
Spanish Society of Cardiology4 个研究点 分布在 1 个国家目标入组 332 人开始时间: 2009年6月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 332
- 试验地点
- 4
- 主要终点
- Comparison of the rate of binary angiographic restenosis (in main vessel and side branch) in the simple versus complex strategy groups
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of the treatment of true bifurcation lesions with the XIENCE V stent using the simple strategy (stent in main vessel and provisional T-stenting in the side branch) compared to the complex strategy (stent in main vessel and T-stenting in the side branch).
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
- •Patients over 18 years old.
- •True Bifurcation lesion (Medina classification 1-1-1), in at least one main coronary vessel. Diameter of main vessel between 2,5-4mm, and diameter of side branch 2mm or greater.
排除标准
- •Significant left main stenosis.
- •ST elevation myocardial infarction < 48 h.
- •Thrombus burden target lesion.
- •Ejection Fraction < 30%.
- •Severe Renal Insufficiency (creatinine > 3 mg/dl).
结局指标
主要结局
Comparison of the rate of binary angiographic restenosis (in main vessel and side branch) in the simple versus complex strategy groups
时间窗: 9 months
次要结局
- Combined rate of events (cardiac death, myocardial infarction and TLR)(8 months)
研究者
研究点 (4)
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