Minimally Invasive Coronary Artery Bypass Grafting Achieving Complete Revascularization of Multivessel Coronary Artery Disease Via Inferior Part-Sternotomy (The ACRIS-MICABG Trial)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 260
- 主要终点
- Complete revascularization rate immediately after surgery
研究概览
简要总结
To verify the effectiveness and safety of minimally invasive coronary artery bypass grafting for complete revascularization of multivessel coronary artery disease via inferior part-sternotomy, We aim to randomize 260 patients undergoing isolated Coronary artery bypass grafting (CABG) to compare the ratios of complete revascularization between inferior part-sternotomy CABG and full median sternotomy CABG from 9 hospitals in China.
详细描述
Coronary artery bypass grafting (CABG) has always been the gold standard for surgical treatment of coronary artery disease (CAD), especially for left main (LM) coronary disease, patients with high SYNTAX scores, and diabetes mellitus. By minimally invasive strategy, patients recover significantly faster in the early post-operative period. However, a prospective randomized controlled trials is needed to compare the ratios of complete revascularization between inferior part-sternotomy CABG and full median sternotomy CABG.
Objectives:
To verify the effectiveness and safety of minimally invasive coronary artery bypass grafting for complete revascularization of multivessel coronary artery disease via inferior part-sternotomy.
Study design:
This is a prospective, multicenter, open-label, randomized controlled trial. We aim to randomize 260 patients undergoing isolated CABG to compare the ratios of complete revascularization between inferior part-sternotomy CABG and full median sternotomy CABG from 9 hospitals in China. We consecutively screen patients during the study enrollment period and seek informed consent from all eligible patients. Patients who give informed consent are randomly assigned to undergo inferior part-sternotomy CABG or full median sternotomy CABG by a central randomization system. An expert group composed of three doctors with CABG qualifications will develop a plan achieving complete revascularization by coronary angiography images before the operation, including the number and location of proximal and distal anastomoses. The actual bypass procedure will be recorded and compared with the preoperative plan. We will follow-up participants until 10 years after the operation. To reduce the variation among surgeons, we require that all CABG are performed by qualified surgeons. The surgeons in this study needs to have experience in at least 100 cases of full median sternotomy CABG, and at least 5 cases of inferior part-sternotomy CABG.The ethics committees at all 9 participating hospitals approved this study.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who undergo primary isolated open-chest CABG with multi-vessel coronary disease(left main artery disease with right coronary artery disease,or three-vessel disease)
排除标准
- •Single vessel disease, double vessel disease, left main artery disease without right coronary artery disease.
- •Concomitant cardiac surgeries(i.e. valve repair or replacement, Maze surgery, left ventricular repair due to ventricular aneurysm).
- •Emergent CABG.
- •Left ventricular ejection fraction(EF≤35%).
- •Severe atherosclerosis of the ascending aorta.
- •Subjects tend to choose surgical approach (via full median sternotomy/inferior part-sternotomy) .
- •Malignant tumor or other severe systemic diseases.
- •Severe renal insufficiency (i.e. creatinine >200 μmol/L).
- •Contraindications for dual antiplatelet therapy, such as active gastroduodenal ulcer.
- •Participant of other ongoing clinical trials.
结局指标
主要结局
Complete revascularization rate immediately after surgery
时间窗: Immediately after surgery
Most surgical groups have adopted the functional definition in their studies. We therefore elected to use a functional definition for complete revascularization in the present study. The coronary vascular tree was divided into 3 separate territories: the left anterior descending artery (LAD), the circumflex artery, and the right coronary artery (RCA).Functional completeness of revascularization is defined as all viable myocardial territories are reperfused, as at least one bypass graft for every diseased primary arterial territory
次要结局
- The harvest time of left Internal mammary artery (LIMA)(During surgery)
- Overall operation time(During surgery)
- Intraoperative real-time blood flow at each anastomosis(During surgery)
- The rate of major adverse cardiac or cerebrovascular events (MACCE) at 5-7 days, 1 year, 3 years, 5 years, and 10 years after surgery(1week after the surgery；10 years after surgery)
- Aortic cross-clamp time(During surgery)
- The total amount of postoperative chest tube drainage(Up to 4 weeks)
- The graft patency rate by CTA at 5-7 days, 1 year, 3 years, 5 years, and 10 years after surgery(1week after the surgery；10 years after surgery)