Coronary Artery Bypass Grafting Clinical Trial
Official title:
Sealing Moderate Coronary Saphenous VEin Graft Lesions With Paclitaxel-Eluting Stents as a New Approach to MainTaining VeIn Graft Patency and Reducing Cardiac Events
Hypothesis: Sealing moderate SVG lesions with paclitaxel-eluting stents reduces cardiac
events (death, myocardial infarction, target vessel revascularization) over the duration of
follow-up.
Primary objective: To evaluate the efficacy of stenting moderate SVG lesions with
paclitaxel-eluting stents on reducing the first occurrence of the composite of cardiac
death, myocardial infarction or repeat revascularization related to the target SVG over the
duration of follow-up (minimun of 2-year follow-up.
This is a prospective, multicenter, randomized study assessing the efficacy of stenting moderate SVG lesions (30% to 60% by visual estimation) with paclitaxel-eluting stents in the prevention of SVG atherosclerosis progression and cardiac events at follow-up. Patients with previous coronary bypass surgery with SVG implantation undergoing coronary angiography by clinical indication will be screened. If the patient has a moderate lesion at any level of the SVGs it will be includable in the study. After inclusion, the patients will be randomized to either stenting the moderate SVG lesion with the taxus stent or standard medical treatment. Following this procedure, all patients will have follow-up visits by telephone or clinic at 30 days, 180 days, 1 year, and yearly until the common study end date. The duration of the study will be approximately 4 years with a minimun of 2-year follow-up. ;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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