Clinical trial NCT05757947: Study of the No-touch Saphenous Vein Graft
Official title: Multicenter Clinical Trial of Myocardial Revascularization Using I-conduit and No-touch Saphenous Vein Graft
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Coronary Artery Disease
Coronary Artery Stenosis
Graft Failure
Cardiac Ischemia
Surgery
Keywords: no-touch saphenous vein graft; CABG
Lead sponsor: Meshalkin Research Institute of Pathology of Circulation
Sponsor class: NETWORK
First posted: 2023-03-07
Enrollment: 106
Sex: ALL
Minimum age (years): 25
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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%

Primary outcomes:
measure: Patency of "no-touch" saphenous vein graft
timeFrame: 12 months after surgery
Secondary outcomes:
measure: Recurrence of angina pectoris
timeFrame: 6 and 12 months after after surgery
measure: MACE
timeFrame: 6 and 12 months after after surgery
measure: Complications of the conduit fence site
timeFrame: 6 and 12 months after after surgery
measure: Survival rate
timeFrame: 6 and 12 months after after surgery
Other outcomes:
Locations:
city: Novosibirsk
country: Russian Federation
facility: NMCR named after academician E.N. Meshalkin of the Ministry of Health of rhe Russian
state: Novosibirsk Region
Study officials:
affiliation: NMCR named after academician E.N. Meshalkin of the Ministry of Health of rhe Russian
name: Dmitry Khvan, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: