Study of the No-touch Saphenous Vein Graft

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Description

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.

Study Overview

Start Date
December 22, 2022
Completion Date
December 22, 2025
Enrollment
106
Date Posted
March 7, 2023
Accepts Healthy Volunteers?
No
Gender
All

Locations

Full Address
NMCR named after academician E.N. Meshalkin of the Ministry of Health of rhe Russian
Novosibirsk, Novosibirsk Region 630055, Russian Federation

Eligibility

Minimum Age (years)
25
Maximum Age (years)
70
Eligibility Criteria
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%

Study Contact Info

Study Contact Name
Dmitry Khvan, Ph.D.
Study Contact Email
Study Contact Phone

Contact Listings Owner Form

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Other Details

FDA Regulated Drug?
No
FDA Regulated Device?
No
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.
NCTid (if applicable)
NCT05757947