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 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
106
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.
NMCR named after academician E.N. Meshalkin of the Ministry of Health of rhe Russian
Novosibirsk, Novosibirsk Oblast, Russia
RECRUITINGPatency of "no-touch" saphenous vein graft
Assessment of the patency of coronary shunts
Time frame: 12 months after surgery
Recurrence of angina pectoris
Estimated percentage of participants with symptomatic angina at 6 and 12 months after surgery
Time frame: 6 and 12 months after after surgery
MACE
Estimated percentage of participants with major adverse cardiac events at 6 and 12 months post-surgery
Time frame: 6 and 12 months after after surgery
Complications of the conduit fence site
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
Time frame: 6 and 12 months after after surgery
Survival rate
Estimated percentage of participants who died at 6 and 12 months after surgery
Time frame: 6 and 12 months after after surgery
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.