Comparing two surgical techniques for 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

This study is testing which of two surgical methods for heart bypass surgery works better in keeping the grafts open and reducing complications for patients.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 300 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Second Hospital of Jilin University (Academic / other)
• Locations: 2 sites (Changchun, Jilin and 1 other locations)
• Trial ID: NCT06787651 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of two surgical methods, RIMA-SVG and Ao-SVG, in patients undergoing coronary artery bypass grafting (CABG). A total of 300 patients will be randomly assigned to either the RIMA-SVG group, where saphenous vein grafts are connected to the right internal mammary artery, or the Ao-SVG group, where grafts are connected to the ascending aorta. The primary outcome is the patency of the grafts after one year, while secondary outcomes include complications such as mortality and major adverse cardiovascular events. Patients will be monitored for 12 months post-surgery to assess their clinical outcomes and graft health.

Who should consider this trial

Good fit: Ideal candidates are patients aged 18 to 80 years scheduled for their first planned CABG with at least two sequential saphenous vein grafts.

Not a fit: Patients requiring additional cardiac surgeries or those with severe vascular or systemic conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved graft patency and reduced complications for patients undergoing coronary artery bypass grafting.

How similar studies have performed: Other studies have explored similar surgical techniques, but the specific comparison of RIMA-SVG and Ao-SVG in this context is relatively novel.

Eligibility criteria

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.

Where this trial is running

Changchun, Jilin and 1 other locations

• the Second Hospital of Jilin University — Changchun, Jilin, China (Recruiting)
• the Second Hospital of Jilin University — Changchun, Jilin, China (Recruiting)

Study contacts

• Study coordinator: kexiang liu, Ph.D.

Conditions Coronary Artery Bypass Grafting; Coronary Artery Disease; Saphenous Vein; Graft Patency; Saphenous Vein Graft; Major Adverse Cardiovascular Events; Right Internal Mammary Artery; Neurological complications