The eSVS® Mesh Randomized Post-Market Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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.

Conditions
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Coronary Artery Disease, Myocardial Ischemia, Coronary Disease, Heart Diseases, Cardiovascular Diseases, Arteriosclerosis, Arterial Occlusive Diseases, Vascular Diseases

Intervention / Treatment
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* Device: eSVS® Mesh


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: SVG + eSVS Mesh vs Control SVG<br>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<br>* 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.<br>* Other names: external Saphenous Vein Support Mesh;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patency of external Saphenous Vein Support (eSVS) Mesh Saphenous Vein Graft (SVG) versus Control SVG | Patency of eSVS Mesh and Control SVGs assessed by spiral CT or angiography at 3-6 months following surgery. | 3-6 Months | 
| Patency and percent stenosis of the eSVS Mesh and Control Saphenous Vein Grafts | Patency and percent stenosis of the eSVS Mesh and Control SVGs assessed by angiography at 24 months following surgery | 24 Months | 
| The occurrence of any Major Adverse Cardiac Event (MACE) | 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. | 3-6 months post implant |