Mid-term Patency of Radial Artery and No Touch Saphenous Vein as Grafts in CABG; A Randomised Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 108
- 试验地点
- 2
- 主要终点
- Functional grafts defined as opened or closed.
研究概览
简要总结
The aim of the study is to evaluate the patency in different kinds of vessels used as graft material in coronary artery bypass grafting.
The hypothesis is that vein grafts harvested with a pedicle of surrounding tissue have the same, or better, patency compared to radial grafts and that skeletonisation of the left internal mammary artery does not effect the patency for this graft.
详细描述
Patients undergoing coronary artery bypass grafting are included in the study.
Each patient receive a radial artery graft and a vein graft harvested with a pedicle of surrounding tissue to the right and left side of the heart respectively. The left internal mammary artery is used for the left anterior descending artery in a skeletonised or non-skeletonised fashion.
The evaluation is made with angiography up to 5 years after surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Isolated coronary artery disease embracing all three main branches of the coronary artery tree.
排除标准
- •Kidney insufficiency (Creatinine > 120 µmol/L)
- •War-farin anticoagulation therapy
- •Ejection fraction < 40%
- •Repeat operation
- •Other concurrent sur-gery
- •Signs of reduced circulation in non-dominant hand
- •Other severe illness, or if the patient declines to participate.
结局指标
主要结局
Functional grafts defined as opened or closed.
时间窗: Up to 5 years after surgery.
次要结局
- Degree of stenosis in implanted grafts.(Up to 5 years after surgery.)