NCT01860274已完成不适用
External Mesh of Vein Grafts In Coronary Artery Bypass Grating: Early Patency and Clinical Outcome
Cardiochirurgia E.H.3 个研究点 分布在 1 个国家目标入组 102 人开始时间: 2015年9月6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
- 102
- 试验地点
- 3
- 主要终点
- Patency
研究概览
简要总结
The study hypothesis is that a meshed conduit made of safen vein allows a better patency at mid-long term than a safen vein alone.
To test this hypothesis the investigators plan a prospective, randomized study, comparing grafts to the diagonal, in cases of vessel diameter under 1.5mm. A control angiography will be performed one year after the operation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical Indication for elective Coronary Artery Bypass Grafting with at least one vein graft
- •Coronary artery with critical stenosis (over 70%)
排除标准
- 未提供
结局指标
主要结局
Patency
时间窗: 6 to 12 months
Patency of graft at CT Scan
次要结局
- Major Adverse Cardiac and Cerebrovascular Events (MACCE)(60 months)
- Vein graft lumen uniformity(6 to 12 months)
研究者
研究点 (3)
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