A Randomised Controlled Trial to Compare Angiographic Patency of Radial Artery Versus Saphenous Vein Used as Free Aorto-coronary Grafts in Coronary Revascularization
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 142
- 试验地点
- 2
- 主要终点
- Patency Rates
研究概览
简要总结
The purpose of this study is to determine whether the radial artery (artery in the arm) or saphenous vein (vein in the leg), when used as bypass grafts for coronary artery bypass surgery, have a greater patency rate (degree of opening)at 5 years after surgery.
详细描述
Arteries differ from veins both in morphology and physiology. Thus the way they behave as in vivo conduits when used in coronary artery bypass grafting is also likely to be different. This may partly explain the predisposition of veins used as coronary conduits to accelerated atherosclerosis in comparison with the internal mammary artery grafts. There are presently few data describing the properties of the radial artery as an in-vivo coronary conduit over the longer-term.
The study will compare angiographic patency of the radial artery or saphenous vein graft anastomosed to the native left circumflex coronary territory at 3 months and 5 years after surgery. A substudy will compare 5-year post-surgery diameter and blood flow of in-vivo radial artery and saphenous vein grafts in response to endothelium-dependent and non-endothelium-dependent stimuli when patients attend for their scheduled follow-up angiogram.
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
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •on waiting list for clinically-indicated myocardial revascularization surgery
- •aged 40-70 years
- •significant stenosis (≥70%) in the circumflex territory as identified on preoperative angiograms
- •negative Allen's test (defined as the return of palmar circulation within 5 seconds of releasing ulnar artery compression)
- •willing to give written informed consent
排除标准
- •poor left ventricular (LV) function (LV ejection fraction <25%)
- •severe diffuse peripheral vascular disease or bilateral varicose venous disease
- •inability to comply with the angiographic follow-up at 3 months or/and 5 years
研究组 & 干预措施
Saphenous vein
Saphenous vein aortocoronary bypass graft
干预措施: Coronary artery bypass graft (CABG) surgery (Procedure)
Radial artery
Radial artery aortocoronary bypass graft
干预措施: Coronary artery bypass graft (CABG) surgery (Procedure)
结局指标
主要结局
Patency Rates
时间窗: 5 years
Angiographic patency rates of radial artery and long saphenous vein grafts at follow-up angiography
Mean Diameter of the Study Graft (Saphenous Vein or Radial Artery)
时间窗: 5 year follow-up
Diameter response of the study vessel (saphenous vein or radial artery graft) to acetylcholine, measured using quantitative coronary angiography from the coronary angiogram.
次要结局
- Blood Flow Volume(5 years)