Comparing two methods for using saphenous vein in heart bypass surgery
Comparison Between the Saphenous Vein as Y-composite Graft Based on the Left Internal Thoracic Artery Versus Aortocoronary Conduit for Coronary Artery Bypass Grafting: A Prospective Randomized Controlled Trial
NA · Seoul National University Hospital · NCT05704296
This study is testing two different ways to use a vein from the leg in heart bypass surgery to see which method works better for patients.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 290 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Seoul National University Hospital (other) |
| Locations | 1 site (Seoul) |
| Trial ID | NCT05704296 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of two different grafting techniques for coronary artery bypass grafting (CABG) using the saphenous vein. Patients will be randomized to receive either a Y-composite graft with the left internal thoracic artery or an aortocoronary conduit. The study aims to assess the morphologic changes of the saphenous vein graft and its patency at one year through intravascular ultrasound and angiography. The trial will involve routine sternotomy and follow-up evaluations to determine clinical outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults over 19 years old who are scheduled for CABG involving the left internal thoracic artery and saphenous vein graft.
Not a fit: Patients with severe comorbidities, those requiring other surgical procedures, or those with unsuitable grafts will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the long-term success rates of CABG procedures by identifying the optimal use of saphenous vein grafts.
How similar studies have performed: Previous studies have shown promising results with the 'No touch saphenous vein' technique, but this specific comparison of graft configurations is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * A patient who is going to receive coronary artery bypass grafting * Older than 19 years * Coronary artery bypass grafting is going to be performed with left internal thoracic artery and saphenous vein graft Exclusion Criteria: * Other concomitant procedures (e.g. valve or aorta surgery) is planned * Patients with severe comorbidities which limit the life expectancy of them below 1 year (e.g. terminal cancer) * Patients whose left internal thoracic artery or saphenous vein is not available due to the low quality, severe injury, or absence of the graft * Patients whose ascending aorta is not suitable to aortocoronary anastomosis (e.g. ascending aorta aneurysm, porcelain aorta) * Emergency operation * Patients who have connective tissue disease * Reoperative coronary artery bypass grafting
Where this trial is running
Seoul
- Seoul National University Hospital — Seoul, South Korea (RECRUITING)
Study contacts
- Principal investigator: Ho Young Hwang, MD, PhD — Seoul National University Hospital
- Study coordinator: Ho Young Hwang, MD, PhD
- Email: scalpel@snu.ac.kr
- Phone: 00-82-10-4004-3673
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Coronary Artery Disease, coronary artery bypass grafting, saphenous vein, coronary angiography