The eSVS® Mesh Randomized Post-Market Study
|ClinicalTrials.gov Identifier: NCT01462721|
Recruitment Status : Terminated
First Posted : October 31, 2011
Last Update Posted : February 28, 2014
|Condition or disease||Intervention/treatment||Phase|
|Coronary Artery Disease Myocardial Ischemia Coronary Disease Heart Diseases Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases||Device: eSVS® Mesh||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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.|
|Study Start Date :||October 2011|
|Actual Primary Completion Date :||February 2013|
|Actual Study Completion Date :||February 2013|
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.
- Patency of external Saphenous Vein Support (eSVS) Mesh Saphenous Vein Graft (SVG) versus Control SVG [ Time Frame: 3-6 Months ]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 ]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 ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01462721
|University Hospital of Kiel|
|Kiel, Germany, 24105|
|Study Director:||Randy LaBounty||Kips Bay Medical, Inc.|