The eSVS® Mesh Randomized Post-Market Study
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.
Coronary Artery Disease
Arterial Occlusive Diseases
Device: eSVS® Mesh
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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.|
- Patency of external Saphenous Vein Support (eSVS) Mesh Saphenous Vein Graft (SVG) versus Control SVG [ Time Frame: 3-6 Months ] [ Designated as safety issue: No ]Patency of eSVS Mesh and Control SVGs assessed by spiral CT or angiography at 3-6 months following surgery.
- Patency and percent stenosis of the eSVS Mesh and Control Saphenous Vein Grafts [ Time Frame: 24 Months ] [ Designated as safety issue: No ]Patency and percent stenosis of the eSVS Mesh and Control SVGs assessed by angiography at 24 months following surgery
- The occurrence of any Major Adverse Cardiac Event (MACE) [ Time Frame: 3-6 months post implant ] [ Designated as safety issue: Yes ]The occurrence of the MACE composite of death, myocardial infarction (Q wave and non-Q wave), stroke, coronary revascularization (i.e. coronary artery bypass surgery or percutaneous coronary intervention), and at 3 to 6-months postimplant.
|Study Start Date:||October 2011|
|Study Completion Date:||February 2013|
|Primary Completion Date:||February 2013 (Final data collection date for primary outcome measure)|
SVG + eSVS Mesh vs Control SVG
Either the Circumflex Coronary Artery (Cx) or the Right Coronary Artery (RCA) will receive the mesh supported vein graft and the native saphenous vein as second and control graft.
Device: eSVS® Mesh
Patients with multi-vessel coronary artery disease who require saphenous vein graft (SVG) coronary artery bypass graft (CABG) surgery of the Right coronary Artery (RCA) and the Circumflex Artery (Cx) due to atherosclerotic coronary artery disease will serve as their own control. They will be randomized to either an SVG+eSVS Mesh to the RCA and an SVG to the Cx or an SVG to the RCA and an SVG+eSVS Mesh to the Cx.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01462721
|University Hospital of Kiel|
|Kiel, Germany, 24105|
|Study Director:||Randy LaBounty||Kips Bay Medical, Inc.|