Study of the No-touch Saphenous Vein Graft

Multicenter Clinical Trial of Myocardial Revascularization Using I-conduit and No-touch Saphenous Vein Graft

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.

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 25%. 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 25%. 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.

Revascularization of the right coronary artery basin will be performed using "no-touch" SVG and the formation of an anastomosis of the stump of the right internal mammary artery and end-to-end saphenous vein graft.

Revascularization of the right coronary artery basin will be performed using "no-touch" SVG and anastomosis of the saphenous vein graft to aorta.

Estimated percentage of participants with major adverse cardiac events at 6 and 12 months post-surgery

Estimated percentage of participants with wound complications, development of wound infection, postoperative neurological complications at the sampling site at 6 and 12 months after surgery

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 HAV 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.