Study of the No-touch Saphenous Vein Graft
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
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 25%. 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 25%. 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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: "no-touch" saphenous vein as I-graft Coronary bypass surgery according to the I-graft method. Proximal anastomosis to RIMA. |
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.
|
| Active Comparator: "no-touch" saphenous vein as conventional free graft Coronary artery bypass grafting using the free conduit technique. Proximal anastomosis to aorta. |
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.
|
Outcome Measures
Primary Outcome Measures
- Patency of "no-touch" saphenous vein graft [12 months after surgery]
Assessment of the patency of coronary shunts
Secondary Outcome Measures
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients with coronary artery disease requiring three-vessel myocardial revascularization
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Patient consent to the study
Exclusion Criteria:
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The diameter of the target arteries for conduits of the internal mammary arteries is less than 1 mm
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Hemodynamically significant atherosclerosis of the subclavian arteries in the first segment
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Stenosis of the right coronary artery less than 90%
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Concomitant pathology requiring additional simultaneous surgical correction
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Lack of HAV
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COPD with FEV1 <60%
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BMI >35
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Prior heart surgery
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Oncological diseases with a life expectancy of less than 5 years
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ACS
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CKD stage 4 and higher
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The diameter of the SVG is less than 2 mm or its varicose expansion is more than 6 mm
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CLTI IIb and more.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | NMCR named after academician E.N. Meshalkin of the Ministry of Health of rhe Russian | Novosibirsk | Novosibirsk Region | Russian Federation | 630055 |
Sponsors and Collaborators
- Meshalkin Research Institute of Pathology of Circulation
Investigators
- Principal Investigator: Dmitry Khvan, Ph.D., NMCR named after academician E.N. Meshalkin of the Ministry of Health of rhe Russian
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Super-SVG