Comparing two methods of using saphenous vein grafts in heart surgery
Multicenter Clinical Trial of Myocardial Revascularization Using I-conduit and No-touch Saphenous Vein Graft
This study is testing if a new way of using saphenous vein grafts during heart surgery can help patients have better long-term success with their grafts compared to the traditional method.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 106 (estimated) |
| Ages | 25 Years to 70 Years |
| Sex | All |
| Sponsor | Meshalkin Research Institute of Pathology of Circulation Research network |
| Locations | 1 site (Novosibirsk, Novosibirsk Region) |
| Trial ID | NCT05757947 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of the 'no-touch' saphenous vein graft used as an I graft compared to its use as a conventional free graft in patients undergoing coronary artery bypass surgery. It is a multicenter, single-blind, prospective randomized study aiming to determine if the I graft method leads to better graft patency rates. A total of 106 patients will be randomly assigned to either the I graft or conventional free graft group, with outcomes assessed to see if there is a significant difference in graft success. The study has received Institutional Review Board approval and employs a blinding process to ensure unbiased results.
Who should consider this trial
Good fit: Ideal candidates are patients with coronary artery disease requiring three-vessel myocardial revascularization who consent to participate in the study.
Not a fit: Patients with significant comorbidities, prior heart surgery, or specific anatomical issues that disqualify them from the grafting methods will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve graft patency rates in coronary artery bypass surgery, leading to better long-term outcomes for patients with coronary artery disease.
How similar studies have performed: While this approach is innovative, similar studies have shown varying results, indicating that further investigation is warranted.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with coronary artery disease requiring three-vessel myocardial revascularization * Patient consent to the study Exclusion Criteria: * The diameter of the target arteries for conduits of the internal mammary arteries is less than 1 mm * Hemodynamically significant atherosclerosis of the subclavian arteries in the first segment * Stenosis of the right coronary artery less than 90% * Concomitant pathology requiring additional simultaneous surgical correction * Lack of IMA * COPD with FEV1 \<60% * BMI \>35 * Prior heart surgery * Oncological diseases with a life expectancy of less than 5 years * ACS * CKD stage 4 and higher * The diameter of the SVG is less than 2 mm or its varicose expansion is more than 6 mm * CLTI IIb and more * Atherosclerosis of the brachiocephalic artery more than 50%
Where this trial is running
Novosibirsk, Novosibirsk Region
- NMCR named after academician E.N. Meshalkin of the Ministry of Health of rhe Russian — Novosibirsk, Novosibirsk Region, Russian Federation (Recruiting)
Study contacts
- Principal investigator: Dmitry Khvan, Ph.D. — NMCR named after academician E.N. Meshalkin of the Ministry of Health of rhe Russian
- Study coordinator: Dmitry Khvan, Ph.D.
- Email: dmhvan@mail.ru
- Phone: +79069090505
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.