Clinical Randomized Controlled Trial of the New Method of Selective Coronary Venous Bypass Graft on Improving Curative Effects in Patients With Diffuse Coronary Artery Disease
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 320
- 试验地点
- 1
- 主要终点
- The patency rate of bridge vessels and selective coronary vein
研究概览
简要总结
Apply a new operation method of Left Internal Mammary Artery (LIMA)-Greater Saphenous Vein (GSV)-SCVBG to the treatment of patients with diffuse coronary artery disease,through clinical randomized controlled study,compared with patients of bilateral internal mammary artery (BIMA)-SCVBG and evaluate both of therapeutic effects and prognosis.
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
- — 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with right coronary artery diffuse lesions:Right coronary artery lumen≤1mm，Lesion lengths ≥20mm or multiple segment lesions.
- •Patients of coronary artery bypass grafting (CABG) that can't be treated through endarterectomy.
- •Patients ≤ 70 years old.
- •All enrolled patients must being signed the informed consent.
排除标准
- •Severe heart failure(ejection fraction under 35%) or non coronary atherosclerotic heart disease patients such as combined with severe valvular heart disease.
- •Patients with acute myocardial infarction.
- •Assistant examinations indicate that the bridge vessels can't be used；The left subclavian artery stenosis and/or LIMA lesions；RIMA lesions；varicosis of both great saphenous vein.
研究组 & 干预措施
LIMA-GSV-SCVBG Group
Experimental group: The intervention：we apply a new operation on the patients with diffuse coronary artery disease(DCAD), we choose LIMA-GSV composited Y graft and anastomose the GSV with selective coronary vein.
干预措施: A method of operation: LIMA-GSV-SCVBG (Procedure)
BIMA-SCVBG Group
The other group：The intervention: We choose bilateral internal mammary artery composited LIMA-Right Mammary Internal Artery（RIMA） y graft， and anastomose the RIMA with selective coronary vein.
干预措施: BIMA-SCVBG (Procedure)
结局指标
主要结局
The patency rate of bridge vessels and selective coronary vein
时间窗: 1-3 years
We will assess the patency rate during a follow-up of 1 year, and continue to follow up to 3 years after the end of the project
次要结局
- Main adverse cardiovascular and cerebrovascular events(1-3 years)
- Wound complications(1-3 years)
研究者
Yang Yu
Professor；Chief Physician；
Beijing Anzhen Hospital