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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| "no-touch" saphenous vein as I-graft | Active Comparator | Coronary bypass surgery according to the I-graft method. Proximal anastomosis to RIMA. |
|
| "no-touch" saphenous vein as conventional free graft | Active Comparator | Coronary artery bypass grafting using the free conduit technique. Proximal anastomosis to aorta. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Сoronary bypass surgery according to the I-graft method | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Patency of "no-touch" saphenous vein graft | Assessment of the patency of coronary shunts | 12 months after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence of angina pectoris | Estimated percentage of participants with symptomatic angina at 6 and 12 months after surgery | 6 and 12 months after after surgery |
| MACE | Estimated percentage of participants with major adverse cardiac events at 6 and 12 months post-surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dmitry Khvan, Ph.D. | Contact | +79069090505 | dmhvan@mail.ru |
| Name | Affiliation | Role |
|---|---|---|
| Dmitry Khvan, Ph.D. | NMCR named after academician E.N. Meshalkin of the Ministry of Health of rhe Russian | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NMCR named after academician E.N. Meshalkin of the Ministry of Health of rhe Russian | Recruiting | Novosibirsk | Novosibirsk Oblast | 630055 | Russia |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D023921 | Coronary Stenosis |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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|
| Сoronary bypass surgery by the method of free conduit | Procedure | Revascularization of the right coronary artery basin will be performed using "no-touch" SVG and anastomosis of the saphenous vein graft to aorta. |
|
| 6 and 12 months after after surgery |
| Complications of the conduit fence site | 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 | 6 and 12 months after after surgery |
| Survival rate | Estimated percentage of participants who died at 6 and 12 months after surgery | 6 and 12 months after after surgery |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |