Study of the No-touch Saphenous Vein Graft

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Coronary Artery Disease, Coronary Artery Stenosis, Graft Failure, Cardiac Ischemia, Surgery

Intervention / Treatment
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* Procedure: Сoronary bypass surgery according to the I-graft method
* Procedure: Сoronary bypass surgery by the method of free conduit


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: no-touch saphenous vein as I-graft<br>Coronary bypass surgery according to the I-graft method. Proximal anastomosis to RIMA. | Procedure: Сoronary bypass surgery according to the I-graft method<br>* 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.<br>|
| Active Comparator: no-touch saphenous vein as conventional free graft<br>Coronary artery bypass grafting using the free conduit technique. Proximal anastomosis to aorta. | Procedure: Сoronary bypass surgery by the method of free conduit<br>* Revascularization of the right coronary artery basin will be performed using no-touch SVG and anastomosis of the saphenous vein graft to aorta.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patency of no-touch saphenous vein graft | Assessment of the patency of coronary shunts | 12 months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence of angina pectoris | Estimated percentage of participants with symptomatic angina at 6 and 12 months after surgery | 6 and 12 months after after surgery | 
| MACE | Estimated percentage of participants with major adverse cardiac events at 6 and 12 months post-surgery | 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 | 6 and 12 months after after surgery | 
| Survival rate | Estimated percentage of participants who died at 6 and 12 months after surgery | 6 and 12 months after after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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no-touch saphenous vein graft; CABG