Comparison of RIMA-SVG and Ao-SVG Techniques in Coronary Artery Bypass Grafting

Not Applicable

Recruiting

• Conditions: Coronary Artery Bypass Grafting; Coronary Artery Disease; Graft Patency; Saphenous Vein

• Registration Number: NCT06787651
• Lead Sponsor: Second Hospital of Jilin University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2025-01-16
• Study First Submitted QC: 2025-01-16
• Study First Posted: 2025-01-22
• Study Start: 2025-02-11
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-11
• Last Update Posted: 2025-03-14
• Primary Completion: 2026-05
• Study Completion: 2026-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
1-Year Graft Patency	1 year post-surgery	The patency of saphenous vein grafts (SVGs) will be assessed 1 year post-surgery using coronary CT angiography

Secondary Outcome Measures

Name	Time	Method
Perioperative complications	2 weeks post-surgery	Incidence of Perioperative complications related to CABG, including myocardial infarction, arrhythmias and other major adverse events.
Neurological Complications	1 year post-surgery	Incidence of neurological complications, including stroke within 1 year after CABG.
All-Cause Mortality	1 year post-surgery	Incidence of MACCE, including cardiovascular death, non-fatal myocardial infarction, Incidence of death from any cause within 1 year after CABG.
Major Adverse Cardiovascular Events (MACE)	1 year post-surgery	Incidence of MACCE, including cardiovascular death, non-fatal myocardial infarction, and target vessel revascularization, within 1 year after CABG.after CABG.
Surgical site infection event	1 year post-surgery	Incidence of surgical site infection event during hospitalization and within 1 year

Trial Locations

Locations (1)

the Second Hospital of Jilin University; 🇨🇳 Changchun, Jilin, China