NCT06787651

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

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Second Hospital of Jilin University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

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.

Conditions

• Coronary Artery Bypass Grafting
• Coronary Artery Disease
• Saphenous Vein
• Graft Patency

Interventions

Type	Name	Description
PROCEDURE	RIMA-SVG	Saphenous vein grafts (SVGs) are connected to the right internal mammary artery (RIMA)
PROCEDURE	Ao-SVG	The ascending aorta is clamped, and SVGs are anastomosed to the aorta.

Timeline

• Start date: 2025-02-01
• Primary completion: 2026-06-01
• Completion: 2026-07-30
• First posted: 2025-01-22
• Last updated: 2025-08-06

Locations

1 site across 1 country: China