Coronary Artery Disease Clinical Trial
Official title:
Multicenter Clinical Trial of Myocardial Revascularization Using I-conduit and No-touch Saphenous Vein Graft
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.
Status | Recruiting |
Enrollment | 106 |
Est. completion date | December 22, 2025 |
Est. primary completion date | April 1, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 25 Years to 70 Years |
Eligibility | 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% |
Country | Name | City | State |
---|---|---|---|
Russian Federation | NMCR named after academician E.N. Meshalkin of the Ministry of Health of rhe Russian | Novosibirsk | Novosibirsk Region |
Lead Sponsor | Collaborator |
---|---|
Meshalkin Research Institute of Pathology of Circulation |
Russian Federation,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Patency of "no-touch" saphenous vein graft | Assessment of the patency of coronary shunts | 12 months after surgery | |
Secondary | 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 | |
Secondary | MACE | Estimated percentage of participants with major adverse cardiac events at 6 and 12 months post-surgery | 6 and 12 months after after surgery | |
Secondary | 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 | |
Secondary | Survival rate | Estimated percentage of participants who died at 6 and 12 months after surgery | 6 and 12 months after after surgery |
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