Multicenter Randomised Prospective Study for External Support Mesh VEST of Venous Coronary Grafts on the Right Territory: Mid-term Clinically Driven Re-rivascularization Events Comparison Between Sites Treated with VEST, Sites Treated with Bare Vein, Sites Treated with Other Conduits and De Novo Lesions on the Native Vessels
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Ri-revascularization of grafted territory
研究概览
简要总结
Multicentre randomised prospective study aimed at verifying medium-term patency of venous grafts on the right coronary artery territory, by clinical and/or instrumental follow-up with particular attention to clinically driven re-revascularisation events regarding the site of new lesions (granularly comparing sites already treated with VEST, sites treated with bare vein, sites treated with other conduits, de novo lesions on the native).
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •combined or isolated interventions
- •adequate vein calibre
- •adequate graft flowmetry
排除标准
- •inability to implant due to calibre disparity or inadequate flowmetry
研究组 & 干预措施
Vested vein
Usage of External mesh support (VEST) around the venous graft
干预措施: CABG (Procedure)
Unvested vein
Normally harvested and preserved "naked" vein used as a graft
干预措施: CABG (Procedure)
结局指标
主要结局
Ri-revascularization of grafted territory
时间窗: Till end of study (at least three years)
Incidence of coronary ri-revascaularization by either angioplasty or surgical bypass concerning the grafted territory due to graft failure
次要结局
- Major Cardiovascular and Cerebrovascular Events (MACCE)(Till end of study (at least three years))