NCT05757947

Study of the No-touch Saphenous Vein Graft

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 106 (estimated)
• Sponsor: Meshalkin Research Institute of Pathology of Circulation · Network
• Sex: All
• Age: 25 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Coronary Artery Disease
• Coronary Artery Stenosis
• Graft Failure
• Cardiac Ischemia
• Surgery

Interventions

Type	Name	Description
PROCEDURE	Сoronary bypass surgery according to the I-graft method	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.
PROCEDURE	Сoronary bypass surgery by the method of free conduit	Revascularization of the right coronary artery basin will be performed using "no-touch" SVG and anastomosis of the saphenous vein graft to aorta.

Timeline

• Start date: 2022-12-22
• Primary completion: 2025-04-01
• Completion: 2025-12-22
• First posted: 2023-03-07
• Last updated: 2024-02-08

Locations

1 site across 1 country: Russia