Study of the No-touch Saphenous Vein Graft
- Conditions
- Coronary Artery StenosisGraft FailureCardiac IschemiaCoronary Artery DiseaseSurgery
- Interventions
- Procedure: 小oronary bypass surgery by the method of free conduitProcedure: 小oronary bypass surgery according to the I-graft method
- Registration Number
- NCT05757947
- Lead Sponsor
- Meshalkin Research Institute of Pathology of Circulation
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 106
- Patients with coronary artery disease requiring three-vessel myocardial revascularization
- Patient consent to the study
- 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%
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description "no-touch" saphenous vein as conventional free graft 小oronary bypass surgery by the method of free conduit Coronary artery bypass grafting using the free conduit technique. Proximal anastomosis to aorta. "no-touch" saphenous vein as I-graft 小oronary bypass surgery according to the I-graft method Coronary bypass surgery according to the I-graft method. Proximal anastomosis to RIMA.
- Primary Outcome Measures
Name Time Method Patency of "no-touch" saphenous vein graft 12 months after surgery Assessment of the patency of coronary shunts
- Secondary Outcome Measures
Name Time Method MACE 6 and 12 months after after surgery Estimated percentage of participants with major adverse cardiac events at 6 and 12 months post-surgery
Complications of the conduit fence site 6 and 12 months after after 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
Recurrence of angina pectoris 6 and 12 months after after surgery Estimated percentage of participants with symptomatic angina at 6 and 12 months after surgery
Survival rate 6 and 12 months after after surgery Estimated percentage of participants who died at 6 and 12 months after surgery
Trial Locations
- Locations (1)
NMCR named after academician E.N. Meshalkin of the Ministry of Health of rhe Russian
馃嚪馃嚭Novosibirsk, Novosibirsk Region, Russian Federation