The eSVS® Mesh Randomized Post-Market Study

Post-market Study to Evaluate Post-implant Patency Rates of the External Saphenous Vein Support (eSVS®) Mesh in the Treatment of Saphenous Vein Grafts (SVGs) During Coronary Artery Bypass Grafting (CABG) Versus SVGs Without the eSVS Mesh.

The purpose of this study is to evaluate patency rates of the external Saphenous Vein Support (eSVS) Mesh Saphenous Vein Grafts (SVG) and Control SVG at 3-6 months and 24 months.

The study will enroll up to 200 patients at up to 6 sites. Patients will be enrolled upon meeting entrance criteria, including obtaining written informed consent. Eligible patients must be clinically indicated for coronary artery bypass grafting (CABG) using autologous saphenous vein grafts (SVG). The study is a prospective, randomized, repeated measure controlled trial based on each patient receiving one control SVG and one external Saphenous Vein Support (eSVS) Mesh treated SVG. Each patient will be their own control.

Inclusion Criteria:

• Patient has been diagnosed with multi-vessel coronary artery disease
• Requires Saphenous Vein Graft (SVG) Coronary Artery Bypass Graft (CABG) surgery of the Right Coronary Artery (RCA) and the Circumflex Artery (Cx) systems due to atherosclerotic coronary artery disease
• SVGs (eSVS Mesh AND Control) meet size requirements as outlined in eSVS Mesh Instructions for Use
• eSVS Mesh implant procedure can be performed as outlined in the eSVS Mesh Instructions for Use
• Are able to give their informed consent

Exclusion Criteria:

• Not able to give informed consent
• No appropriate target coronary vessels
• SVGs (eSVS Mesh or Control) do not meet size requirements as outlined in eSVS Mesh Instructions for Use
• eSVS Mesh implant procedure cannot be performed as outlined in the eSVS Mesh Instructions for Use
• Inability to tolerate or comply with normal post-surgical drug regimen
• Inability to comply with required follow-up coronary angiography/CT