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

NCT06787651 | Active Not Recruiting DMC

• 1 other identifier: JDEYXXGWK460
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Coronary Artery Bypass Grafting; Saphenous Vein Graft; Graft Patency; Major Adverse Cardiovascular Events; Right Internal Mammary Artery; Neurological complications; left internal mammary artery; Surgical site infection event

Outcome Measures

Primary Outcomes (1)

• 1-Year Graft Patency

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

  1 year post-surgery

Secondary Outcomes (5)

• 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

Study Arms (2)

RIMA-SVG Group

EXPERIMENTAL

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

Procedure: RIMA-SVG

Ao-SVG Group

ACTIVE COMPARATOR

SVGs will be connected directly to the ascending aorta.

Procedure: Ao-SVG

Interventions

RIMA-SVG PROCEDURE

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

Also known as: RIMA

RIMA-SVG Group

Ao-SVG PROCEDURE

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

Also known as: Ao

Ao-SVG Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Second Hospital of Jilin University: lead

Study Sites (1)

the Second Hospital of Jilin University

Changchun, Jilin, 130000, China

Location

Related Publications (1)

• 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.

  PMID: 41022447 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• kexiang liu, Ph.D.

  Second Hospital of Jilin University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The surgical team is unblinded during the procedure, but patients and investigators remain blinded throughout the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants are randomly assigned to two groups based on surgical technique (RIMA-SVG vs. Ao-SVG)

Study Record Dates

• First Submitted: January 16, 2025
• First Posted: January 22, 2025
• Study Start: February 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): July 30, 2026
• Last Updated: August 6, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will be shared via request from the corresponding author starting 6 months after study completion and publication.
• Access Criteria: Access to the de-identified individual participant data will be granted to qualified researchers whose proposed use of the data has been reviewed and approved by the trial's principal investigator and data access committee. Applicants must submit a detailed research proposal outlining the scientific rationale, intended analyses, and data protection measures. A data use agreement must be signed prior to data release to ensure compliance with ethical and legal standards.

Locations

CN (1)