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.
Device: eSVS® Mesh
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Full eligibility criteria for NCT01462721
Ages eligible for Study
Genders eligible for Study
Accepts Healthy Volunteers
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
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
All locations for NCT01462721
University Hospital of Kiel
Kiel, Germany, 24105
View full eligibility
Tris trial is registered with FDA with number: NCT01462721. The sponsor of the trial is Kips Bay Medical, Inc. and it is looking for 12 volunteers for the current phase.
Official trial 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.
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