No-touch Saphenous Vein Grafts vs Radial Artery Grafts; A Randomized Trial.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 108
- 试验地点
- 2
- 主要终点
- Graft patency
研究概览
简要总结
The investigators have developed a novel technique for saphenous vein graft harvesting for coronary artery bypass grafting (CABG) where the graft is harvested with a pedicle of surrounding tissue. A randomized trial has shown a significantly higher patency rate for vein grafts harvested with this new methode compared to conventional harvesting technique 8.5 years after surgery (90 vs 76 %). In 2004 the investigators started a prospective randomized trial comparing patency between vein grafts harvested with surrounding tissue and radial artery grafts. The result showed that vein grafts harvested with surrounding tissue had a significantly higher patency rate compared to radial artery grafts 3 years after surgery (98 vs 84 %). The present study is a long-term follow-up (8 years) of the patients included in the second randomized trial. The hypothesis is that vein grafts harvested with surrounding tissue have a significantly higher patency rate compared to radial artery grafts 8 years after surgery.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- — 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Three vessel coronary artery disease
排除标准
- •65 years or older
- •Elevated creatinine
- •Raynauds disease
- •Vein stripping
结局指标
主要结局
Graft patency
时间窗: 5 months
The grafts will be categorized as either "open" or "closed". A stenosis of the graft exceeding 70 % of the lumen diameter will be considered as "closed".
次要结局
未报告次要终点
研究者
Mats Dreifaldt
MD PhD
Region Örebro County