Coronary Artery DiseaseNCT07057713
Total Arterial vs. Mixed Grafting in Left Coronary CABG
A study testing Total Arterial Grafting and Conventional Mixed Grafting in people with Coronary Artery Disease and Coronary Artery Bypass Grafting, run by Second Hospital of Jilin University at 1 site in China.
Trial summary
This is a prospective, randomized, double-blind controlled trial comparing the clinical efficacy of total arterial grafting (internal thoracic artery and radial artery) versus conventional mixed grafting (internal thoracic artery and great saphenous vein) in the left coronary artery system during coronary artery… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary Artery Disease, Coronary Artery Bypass Grafting, Arterial Graft
- What is being tested?
- Total Arterial Grafting and Conventional Mixed Grafting
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2026to 30 Dec 2027
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Diagnosed with multivessel coronary artery disease
- Indicated for elective coronary artery bypass grafting (CABG) involving ≥3 coronary vessels
- Right coronary artery stenosis >75%
- Able and willing to provide written informed consent
Who cannot join
- Scheduled for concurrent cardiac procedures (e.g., valve surgery, congenital heart disease repair, aortic dissection surgery, atrial fibrillation ablation)
- Severe stenosis of left or right subclavian artery
- Unsuitable saphenous veins (e.g., bilateral varicosities)
- Unsuitable radial artery as assessed preoperatively
- History of intracranial hemorrhage or ischemic stroke within the past 14 days
- Severe hepatic or renal insufficiency
- Acute myocardial infarction within 72 hours prior to surgery
- History of prior CABG or other cardiac surgery
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The Second Hospital of Jilin University
Changchun, Jilin, 130000
kexiang liu, Ph.D.
About this study
Official title: A Prospective, Randomized, Double-Blind Controlled Trial Comparing Total Arterial Grafting Versus Conventional Mixed Grafting in the Left Coronary Artery System During Coronary Artery Bypass Grafting (CABG)
This is a prospective, randomized, double-blind controlled trial comparing the clinical efficacy of total arterial grafting (internal thoracic artery and radial artery) versus conventional mixed grafting (internal thoracic artery and great saphenous vein) in the left coronary artery system during coronary artery bypass grafting (CABG). A total of 400 patients undergoing elective CABG at the Second Hospital of Jilin University will be enrolled and randomized into two groups. The primary endpoint is graft patency at 12 months postoperatively, evaluated by coronary angiography or CT angiography. Secondary outcomes include perioperative complications, major adverse cardiovascular events (MACE), and long-term clinical prognosis. The study aims to provide evidence-based guidance on optimal graft selection in CABG.
Read the detailed description
Coronary artery bypass grafting (CABG) remains a cornerstone treatment for multivessel coronary artery disease. The choice of conduit significantly affects long-term graft patency and patient outcomes. While the left internal thoracic artery (LITA) to the left anterior descending artery (LAD) is standard, the optimal strategy for other coronary territories-such as the circumflex and right coronary arteries-remains debated.
This prospective, randomized, double-blind controlled trial aims to evaluate the long-term clinical efficacy of total arterial grafting (LITA + radial artery) versus conventional mixed grafting (LITA + great saphenous vein) in the left coronary artery system. A total of 400 patients scheduled for elective CABG at the Second Hospital of Jilin University will be enrolled and randomly assigned to one of the two surgical strategies. The experimental group will receive total arterial grafts to the LAD and circumflex branches, while the control group will receive arterial graft to LAD and vein grafts to the circumflex.
The primary endpoint is graft patency at 12 months post-surgery, assessed via coronary angiography or CT angiography. Secondary outcomes include major adverse cardiovascular events (MACE), perioperative complications (e.g., myocardial infarction, atrial fibrillation, infection), and long-term changes in cardiac function (e.g., LVEF, NYHA class). All surgeries will be performed by the same experienced surgical team following standardized procedures.
Patients will be followed at 1, 6, and 12 months postoperatively. Data will be collected through the hospital electronic medical record system and analyzed with appropriate statistical methods, including Cox proportional hazards modeling and Kaplan-Meier survival curves. Ethical approval has been obtained, and informed consent will be required from all participants. This study is designed to provide high-level evidence to optimize graft selection strategies in CABG.
- Conditions
- Coronary Artery Disease, Coronary Artery Bypass Grafting, Arterial Graft, Graft Patency, Major Adverse Cardiovascular Events
- Being tested
- Total Arterial Grafting, Conventional Mixed Grafting
- 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.
Total Arterial GraftingProcedure or surgery
Also called LITA + Radial Artery Grafting
Coronary artery bypass grafting using only arterial conduits in the left coronary artery system. The left internal thoracic artery (LITA) is grafted to the LAD, and the radial artery is anastomosed to the obtuse marginal or diagonal branches. This approach avoids the use of saphenous vein grafts for the left coronary system.
Conventional Mixed GraftingProcedure or surgery
Also called Mixed Arterial-Venous Grafting
A standard coronary artery bypass grafting (CABG) procedure where the left internal thoracic artery (LITA) is grafted to the LAD, and saphenous vein grafts are used for the obtuse marginal or diagonal branches of the left coronary system. This approach represents the conventional mixed arterial-venous strategy.
| Study group | Role | What they receive |
|---|---|---|
| Total Arterial Grafting Group | Experimental | Patients in this group will undergo coronary artery bypass grafting (CABG) with total arterial grafts to the left coronary artery system. The left internal thoracic artery (LITA) will be grafted to the left anterior descending artery (LAD), and the radial artery will be anastomosed to the obtuse marginal or diagonal branches of the circumflex artery. The right coronary artery, if revascularized, will receive a conventional vein graft. Receives: Procedure: Total Arterial Grafting |
| Conventional Mixed Grafting Group | Active comparator | Patients in this group will receive conventional mixed grafting during CABG. The left internal thoracic artery (LITA) will be used for the LAD, while the great saphenous vein will be grafted to other branches of the left coronary artery system, such as the obtuse marginal or diagonal branches. The right coronary artery, if revascularized, will also be grafted using a vein. Receives: Procedure: Conventional Mixed Grafting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Graft Patency Rate
Graft patency will be assessed at 12 months after surgery by coronary angiography or coronary CT angiography. A patent graft is defined as one with <50% stenosis and continuous flow. The proportion of patients with all coronary artery grafts remaining patent will be calculated and compared between groups.
Measured: 12 months after surgery
Secondary outcomes (2)
Incidence of Major Adverse Cardiovascular Events
MACE includes cardiac death, nonfatal myocardial infarction, and the need for repeat revascularization. Events will be recorded during hospitalization and follow-up visits up to 12 months after surgery.
Measured: Within 12 months after surgery
Incidence of Perioperative Complications
Includes postoperative atrial fibrillation, stroke, wound infection, renal insufficiency, and reoperation for bleeding. Data will be collected during hospitalization.
Measured: Within 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2025
- Study start1 Aug 2026 (estimated)
- Primary completion1 Aug 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies 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
- Patients undergoing elective CABG will be randomized 1:1 to receive either total arterial grafting or conventional mixed grafting in the left coronary system.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 400 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, Principal investigator, Department of Cardiovascular Surgery, The Second Hospital of Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07057713
- Sponsor's protocol ID
- JDEYXWK208
- Status last verified
- Apr 2026
- First submitted
- 29 Jun 2025
- Last updated
- 23 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No