Study of the No-touch Saphenous Vein Graft

Meshalkin Research Institute of Pathology of Circulation

Status: Enrolling

Conditions: Graft Failure; Coronary Artery Disease; Surgery; Coronary Artery Stenosis; Cardiac Ischemia

Treatments: Procedure: Сoronary bypass surgery by the method of free conduit; Procedure: Сoronary bypass surgery according to the I-graft method

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT05757947

Super-SVG

Details and patient eligibility

About

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.

Full 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.

Enrollment: 106 estimated patients

Sex: All

Ages: 25 to 70 years old

Volunteers: No Healthy Volunteers

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%
• 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%

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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106 participants in 2 patient groups

"no-touch" saphenous vein as I-graft

Active Comparator group

Description:

Coronary bypass surgery according to the I-graft method. Proximal anastomosis to RIMA.

Treatment:

Procedure: Сoronary bypass surgery according to the I-graft method

"no-touch" saphenous vein as conventional free graft

Active Comparator group

Description:

Coronary artery bypass grafting using the free conduit technique. Proximal anastomosis to aorta.

Treatment:

Procedure: Сoronary bypass surgery by the method of free conduit