Clinical trial NCT06787651: Comparison of RIMA-SVG and Ao-SVG Techniques in Coronary Artery Bypass Grafting
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Lead sponsor: Second Hospital of Jilin University
Sponsor class: OTHER
First posted: 2025-01-22
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are randomly assigned to two groups based on surgical technique (RIMA-SVG vs. Ao-SVG)
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: 1-Year Graft Patency
timeFrame: 1 year post-surgery
Secondary outcomes:
measure: Perioperative complications
timeFrame: 2 weeks post-surgery
measure: Neurological Complications
timeFrame: 1 year post-surgery
measure: All-Cause Mortality
timeFrame: 1 year post-surgery
measure: Major Adverse Cardiovascular Events (MACE)
timeFrame: 1 year post-surgery
measure: Surgical site infection event
timeFrame: 1 year post-surgery
Other outcomes:
Locations:
city: Changchun
country: China
facility: the Second Hospital of Jilin University
state: Jilin
city: Changchun
country: China
facility: the Second Hospital of Jilin University
state: Jilin
Study officials:
affiliation: Second Hospital of Jilin University
name: kexiang liu, Ph.D.
role: STUDY_DIRECTOR
References: