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

NCT ID: NCT06787651

Last Updated: 2025-08-06

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-01
• Study Completion Date: 2026-07-30

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

RIMA-SVG Group

Saphenous vein grafts (SVGs) will be connected to the right internal mammary artery (RIMA).

Group Type: EXPERIMENTAL

RIMA-SVG

Intervention Type: PROCEDURE

Saphenous vein grafts (SVGs) are connected to the right internal mammary artery (RIMA)

Ao-SVG Group

SVGs will be connected directly to the ascending aorta.

Group Type: ACTIVE_COMPARATOR

Ao-SVG

Intervention Type: PROCEDURE

The ascending aorta is clamped, and SVGs are anastomosed to the aorta.

Interventions

RIMA-SVG

Saphenous vein grafts (SVGs) are connected to the right internal mammary artery (RIMA)

Intervention Type: PROCEDURE

Ao-SVG

The ascending aorta is clamped, and SVGs are anastomosed to the aorta.

Intervention Type: PROCEDURE

Other Intervention Names

RIMA; Ao

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Second Hospital of Jilin University

OTHER

Sponsor Role: lead

Responsible Party

Kexiang Liu, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

kexiang liu, Ph.D.

Role: STUDY_DIRECTOR

Second Hospital of Jilin University

Locations

the Second Hospital of Jilin University

Changchun, Jilin, China

Countries

China

References

Wei R, Huang M, Jiang N, Zhang R, He T, Zhu C, Wang W, Piao H, Yu S, Zhu Z, Wang T, Liu K. RIMA-SVG versus Ao-SVG in coronary artery bypass grafting: protocol for a prospective, randomised, double-blind, non-inferiority and single-centre trial. BMJ Open. 2025 Sep 28;15(9):e104578. doi: 10.1136/bmjopen-2025-104578.

Reference Type: DERIVED

PMID: 41022447 (View on PubMed)

Other Identifiers

JDEYXXGWK460

Identifier Type: -

Identifier Source: org_study_id