Coronary Artery Bypass GraftingNCT06787651
Comparison of RIMA-SVG and Ao-SVG Techniques in Coronary Artery Bypass Grafting
A study testing RIMA-SVG and Ao-SVG in people with Coronary Artery Bypass Grafting and Coronary Artery Disease, run by Second Hospital of Jilin University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Coronary Artery Bypass Grafting, Coronary Artery Disease, Saphenous Vein
- What is being tested?
- RIMA-SVG and Ao-SVG
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2025to 30 Jul 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Being tested
- RIMA-SVG, Ao-SVG
- 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
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RIMA-SVGProcedure or surgery
Also called RIMA
Saphenous vein grafts (SVGs) are connected to the right internal mammary artery (RIMA)
Ao-SVGProcedure or surgery
Also called Ao
The ascending aorta is clamped, and SVGs are anastomosed to the aorta.
| Study group | Role | What they receive |
|---|---|---|
| RIMA-SVG Group | Experimental | Saphenous vein grafts (SVGs) will be connected to the right internal mammary artery (RIMA). Receives: Procedure: RIMA-SVG |
| Ao-SVG Group | Active comparator | SVGs will be connected directly to the ascending aorta. Receives: Procedure: Ao-SVG |
What is being measured
The primary outcome is the main question the study is designed to answer.
1-Year Graft Patency
The patency of saphenous vein grafts (SVGs) will be assessed 1 year post-surgery using coronary CT angiography
Measured: 1 year post-surgery
Secondary outcomes (5)
Perioperative complications
Incidence of Perioperative complications related to CABG, including myocardial infarction, arrhythmias and other major adverse events.
Measured: 2 weeks post-surgery
Neurological Complications
Incidence of neurological complications, including stroke within 1 year after CABG.
Measured: 1 year post-surgery
All-Cause Mortality
Incidence of MACCE, including cardiovascular death, non-fatal myocardial infarction, Incidence of death from any cause within 1 year after CABG.
Measured: 1 year post-surgery
Major Adverse Cardiovascular Events (MACE)
Incidence of MACCE, including cardiovascular death, non-fatal myocardial infarction, and target vessel revascularization, within 1 year after CABG.after CABG.
Measured: 1 year post-surgery
Surgical site infection event
Incidence of surgical site infection event during hospitalization and within 1 year
Measured: 1 year post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2025
- Study start1 Feb 2025
- Primary completion1 Jun 2026 (estimated)
- Study completion30 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery Bypass GraftingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomly assigned to two groups based on surgical technique (RIMA-SVG vs. Ao-SVG)
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Hospital of Jilin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kexiang Liu, MD, Second Hospital of Jilin University
- Investigators
- kexiang liu, Ph.D., Study director, Second Hospital of Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06787651
- Sponsor's protocol ID
- JDEYXXGWK460
- Status last verified
- Aug 2025
- First submitted
- 16 Jan 2025
- Last updated
- 6 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) underlying the primary and secondary outcomes of the study-including baseline characteristics, graft patency results, perioperative complications, and 12-month clinical outcomes-will be made available upon reasonable request. Data will be shared with qualified researchers following study completion and publication, subject to approval by the trial steering committee and in accordance with ethical and data protection guidelines.
Publications
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.
PubMed 41022447