Comparison of Total Arterial Revascularization of Y-Graft Versus In-Situ Configuration Using Bilateral Internal Thoracic Arteries
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 880
- 试验地点
- 2
- 主要终点
- Freedom from MACCE
研究概览
简要总结
Total arterial revascularisation with in-situ confihuration of BITA is superior than y-graft in patients underwent CABG.
详细描述
The main hypothesis of the trial is that in-situ configuration of bilateral internal thoracic arteries is superior than Y-graft configuration for MACCE (mortality, myocardial infarction, repeat revascularization, stroke) during mid-term follow-up in patients with CAD who is shedueled for CABG.
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
- •Coronary Artery Disease
- •Stable angina
- •The need for revascularization of anterior descending and obtuse margin arteries accoring to the 2018 ESC/EACTS Guidelines on myocardial revascularization
- •Informed Consent Form
排除标准
- •The diameter of the target arteries is less than 1 mm
- •Stenosis of the subclavian arteries more than 60%
- •STEMI less than 3 month
- •Previous cardiac surgery
- •COPD with FEV1 <60%
- •Concomitant pathology that requires simultaneous surgical treatment
- •Cancer with life expectancy less than 5 years
研究组 & 干预措施
Y-Graft
The group includes patients who underwent CABG in Y-Graft Configuration.
干预措施: Y-Graft (Procedure)
In-Situ
The group includes patients who underwent CABG in In-Situ Configuration.
干预措施: In-Situ (Procedure)
结局指标
主要结局
Freedom from MACCE
时间窗: 5 years
Composite MACCE (mortality, myocardial infarction, repeated revascularization, stroke)
次要结局
- Treadmill stress test(5 years)
- Graft patency(5 years)
- Quality of life (SF-36)(5 years)
研究者
Dmitry Sirota
Head of the surgery of aorta and coronary arteries department
Meshalkin Research Institute of Pathology of Circulation