Multicenter Clinical Trial of Myocardial Revascularization Using I-conduit and No-touch Saphenous Vein Graft
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Coronary Artery Disease
- Sponsor
- Meshalkin Research Institute of Pathology of Circulation
- Enrollment
- 106
- Locations
- 1
- Primary Endpoint
- Patency of "no-touch" saphenous vein graft
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
Authors hypothesize that "no-touch" saphenous vein as I graft is superior over conventional "no-touch" saphenous vein as free graft in the incidence of graft patency.
Detailed Description
A multicenter single blind prospective randomized superiority study is conducted. Our hypothesis is that there is difference in the incidence of "no-touch" saphenous vein graft patency using it as the conventional free graft (group C) and I graft (group I) for myocardial revascularization more than 28%. If there is truly difference between groups, then total 106 patients for both groups are required to be 90% sure that the upper limit of a one-sided 95% confidence interval would reveal a difference in favour of the "no-touch" saphenous vein I graft of 28%. The blinding process is applied to a patient, who is informed about received harvesting method of saphenous vein, but don't know the type of the graft cofiguration. The study was approved by Institutional Review Board. Depending on a type of the procedure, the patients are divided into two groups: conventional free graft (group C) 53 patients and I graft (group I) 53 patients. Randomization is conducted befor operation by using accidental sampling.
Investigators
Dmitry Khvan
candidate of medical sciences, senior researcher, сardiovascular surgeon of the NMRC named after academician E.N. Meshalkin of the Ministry of Health of Russian Federation
Meshalkin Research Institute of Pathology of Circulation
Eligibility 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%
- •Prior heart surgery
- •Oncological diseases with a life expectancy of less than 5 years
- •CKD stage 4 and higher
- •The diameter of the SVG is less than 2 mm or its varicose expansion is more than 6 mm
Outcomes
Primary Outcomes
Patency of "no-touch" saphenous vein graft
Time Frame: 12 months after surgery
Assessment of the patency of coronary shunts
Secondary Outcomes
- MACE(6 and 12 months after after surgery)
- Complications of the conduit fence site(6 and 12 months after after surgery)
- Recurrence of angina pectoris(6 and 12 months after after surgery)
- Survival rate(6 and 12 months after after surgery)