Coronary Artery Disease Clinical Trial
Official title:
Post-market Study to Evaluate Post-implant Patency Rates of the eSVS Mesh in the Treatment of Saphenous Vein Graphs During Coronary Artery Bypass Grafting Versus Saphenous Vein Grafts Without the eSVS Mesh Via Coronary Angiography and Duplex Ultra-Sonography Results
The purpose of this study is to evaluate patency rates of the eSVS Mesh Saphenous Vein Graph (SVG) and control SVG at six and twenty-four months via coronary angiography and analyses of Duplex Sonography Results and coronary angiography and major cardiovascular or cerebrovascular event (MACCE)-Rate as well as analysis of preoperative great saphenous vein (GSV) duplex sonography and intra-operative GSV harvesting findings and procedure.
This Study will enroll up to 100 patients total. Patients will be enrolled upon meeting certain inclusion criteria, including GSV duplex-sonography results and consent. They will be enrolled based on their clinically indicated requirement for coronary artery bypass grafting with use of their saphenous vein graft. The study will be prospective, randomized repeated measure controlled trial based on the patient's ability to receive both control and eSVS Mesh treatment. Graft patency, MACCE at 6 and 24 months after meshed and non meshed GSV graft implantation will be measured and the findings and qualification of GSV in preoperative duplex sonography will be compared with intraoperative findings while GSV harvesting in order to evaluate the safety of the eSVS mesh and the role of preoperative GSV duplex sonography. ;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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