Multicenter Clinical Trial of Myocardial Revascularization Using I-conduit and No-touch Saphenous Vein Graft
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 106
- 试验地点
- 2
- 主要终点
- Patency of "no-touch" saphenous vein graft
研究概览
简要总结
Authors hypothesize that "no-touch" saphenous vein as I graft is superior over conventional "no-touch" saphenous vein as free graft in the incidence of graft patency.
详细描述
A multicenter single blind prospective randomized superiority study is conducted. Our hypothesis is that there is difference in the incidence of "no-touch" saphenous vein graft patency using it as the conventional free graft (group C) and I graft (group I) for myocardial revascularization more than 28%. If there is truly difference between groups, then total 106 patients for both groups are required to be 90% sure that the upper limit of a one-sided 95% confidence interval would reveal a difference in favour of the "no-touch" saphenous vein I graft of 28%. The blinding process is applied to a patient, who is informed about received harvesting method of saphenous vein, but don't know the type of the graft cofiguration. The study was approved by Institutional Review Board. Depending on a type of the procedure, the patients are divided into two groups: conventional free graft (group C) 53 patients and I graft (group I) 53 patients. Randomization is conducted befor operation by using accidental sampling.
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 (Participant)
入排标准
- 年龄范围
- 25 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with coronary artery disease requiring three-vessel myocardial revascularization
- •Patient consent to the study
排除标准
- •The diameter of the target arteries for conduits of the internal mammary arteries is less than 1 mm
- •Hemodynamically significant atherosclerosis of the subclavian arteries in the first segment
- •Stenosis of the right coronary artery less than 90%
- •Concomitant pathology requiring additional simultaneous surgical correction
- •Lack of IMA
- •COPD with FEV1 <60%
- •Prior heart surgery
- •Oncological diseases with a life expectancy of less than 5 years
- •CKD stage 4 and higher
- •The diameter of the SVG is less than 2 mm or its varicose expansion is more than 6 mm
- •CLTI IIb and more
- •Atherosclerosis of the brachiocephalic artery more than 50%
结局指标
主要结局
Patency of "no-touch" saphenous vein graft
时间窗: 12 months after surgery
Assessment of the patency of coronary shunts
次要结局
- MACE(6 and 12 months after after surgery)
- Complications of the conduit fence site(6 and 12 months after after surgery)
- Recurrence of angina pectoris(6 and 12 months after after surgery)
- Survival rate(6 and 12 months after after surgery)
研究者
Dmitry Khvan
candidate of medical sciences, senior researcher, сardiovascular surgeon of the NMRC named after academician E.N. Meshalkin of the Ministry of Health of Russian Federation
Meshalkin Research Institute of Pathology of Circulation