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临床试验/NCT06787651
NCT06787651进行中(未招募)不适用

Comparison of RIMA-SVG and Ao-SVG Techniques in Coronary Artery Bypass Grafting : A Prospective Randomized Double-Blind Study on Graft Patency and Clinical Outcomes

Second Hospital of Jilin University1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2025年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
300
试验地点
1
主要终点
1-Year Graft Patency

研究概览

简要总结

This randomized, double-blind, single-center clinical trial was divided into two groups, RIMA-SVG and Ao-SVG, according to the surgical method. The purpose was to evaluate the effect of the RIMA-SVG surgical method in improving saphenous vein graft (SVG) patency and reducing clinical complications. A total of 300 patients will be enrolled and randomly assigned to two surgical method groups: RIMA-SVG Group (150 patients): SVGs are connected to the right internal mammary artery (RIMA). Ao-SVG Group (150 patients): The aorta is clamped, and SVGs are connected to the ascending aorta (Ao).All patients will undergo CABG on a beating heart with sequential vein grafts to bypass at least two or more coronary vessels. The primary outcome is 1-year graft patency. The secondary outcomes include neurological complications, mortality, major adverse cardiovascular events (MACE), and surgical site infection event.

详细描述

This randomized, double-blind, single-center clinical trial was divided into two groups, RIMA-SVG and Ao-SVG, according to the surgical method. The purpose was to evaluate the effect of the RIMA-SVG surgical method in improving saphenous vein graft (SVG) patency and reducing clinical complications. A total of 300 patients undergoing CABG on a beating heart will be randomized into two surgical technique groups: RIMA-SV Group (150 patients): SVGs are anastomosed to the right internal mammary artery (RIMA). Ao-SVG Group (150 patients): The ascending aorta is clamped, and SVGs are anastomosed to the aorta. All patients will undergo CABG via median sternotomy, and the left internal mammary artery (LIMA) will be used to bypass the left anterior descending artery (LAD). SVGs will be sequentially grafted to the circumflex artery, diagonal branch, and right coronary artery. The primary outcome is 1-year graft patency, assessed by coronary CT angiography and classified using the FitzGibbon grading system. Secondary outcomes include all-cause mortality, major adverse cardiovascular events (MACE), neurological complications, and surgical site infection event. Patients will be followed at 12 months for clinical evaluations and imaging assessments. Inclusion criteria include patients aged 18 to 80 years undergoing planned CABG with at least two sequential saphenous vein grafts and who are able to provide written informed consent. Exclusion criteria include additional cardiac surgeries, severe subclavian artery stenosis, unsuitable SVGs (e.g. bilateral varicosities), history of intracranial hemorrhage, active bleeding, malignancy, or emergency surgery. Randomization will be computer-generated, and all aspects of the study will remain blinded to ensure unbiased assessments.

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
Double (Participant, Investigator)

盲法说明

The surgical team is unblinded during the procedure, but patients and investigators remain blinded throughout the study.

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

入选标准

  • Patients aged 18 to 80 years.
  • Scheduled for their first planned coronary artery bypass grafting (CABG) with at least two sequential saphenous vein grafts (SVGs).
  • Able and willing to provide written informed consent.

排除标准

  • Patients unable to provide written informed consent.
  • Patients requiring other cardiac surgeries (e.g. valve replacement, congenital heart defect surgery, or aortic dissection repair).
  • Patients with severe stenosis of the left or right subclavian artery.
  • Patients for whom aortic clamping is infeasible due to calcification of the ascending aorta.
  • Patients with bilateral SVG varicosities unsuitable for grafting.
  • Patients with active malignancy.
  • Patients with active bleeding or a history of bleeding tendency.
  • Patients with previous intracranial hemorrhage, ischemic stroke within 14 days preoperatively, or severe carotid artery stenosis.
  • Patients with severe hepatic dysfunction.
  • Patients requiring emergency surgery.

结局指标

主要结局

1-Year Graft Patency

时间窗: 1 year post-surgery

The patency of saphenous vein grafts (SVGs) will be assessed 1 year post-surgery using coronary CT angiography

次要结局

  • Perioperative complications(2 weeks post-surgery)
  • Neurological Complications(1 year post-surgery)
  • All-Cause Mortality(1 year post-surgery)
  • Major Adverse Cardiovascular Events (MACE)(1 year post-surgery)
  • Surgical site infection event(1 year post-surgery)

研究者

发起方
Second Hospital of Jilin University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Kexiang Liu, MD

Principal Investigator

Second Hospital of Jilin University

研究点 (1)

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