Cardiac Ischemia, Coronary Artery Disease, Coronary Artery Stenosis, Graft Failure, Surgery
Conditions
Keywords
no-touch saphenous vein graft; CABG
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.
Interventions
PROCEDUREСoronary 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.
PROCEDUREСoronary 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.
Sponsors
Meshalkin Research Institute of Pathology of Circulation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
25 Years to 70 Years
Healthy volunteers
No
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%
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patency of no-touch saphenous vein graft | 12 months after surgery | Assessment of the patency of coronary shunts |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence of angina pectoris | 6 and 12 months after after surgery | Estimated percentage of participants with symptomatic angina at 6 and 12 months after surgery |
| MACE | 6 and 12 months after after surgery | Estimated percentage of participants with major adverse cardiac events at 6 and 12 months post-surgery |
| Complications of the conduit fence site | 6 and 12 months after after surgery | 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 |
| Survival rate | 6 and 12 months after after surgery | Estimated percentage of participants who died at 6 and 12 months after surgery |
Countries
Russia
Contacts
Primary ContactDmitry Khvan, Ph.D.
Outcome results
None listed