The eSVS (TM) Mesh External Saphenous Vein Support Trial

Study Overview
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Brief Summary
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Prospective, multi-center, randomized, controlled (patients as their own control) trial on an external mesh device (eSVS™, Kips Bay Medical) supporting saphenous vein grafts for coronary bypass graft surgery in patients with multi-vessel coronary heart disease.

Detailed Description
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The objective of the eSVS™ Mesh Saphenous Vein Support Trial is to prospectively evaluate the clinical safety and efficacy of the eSVS™ Mesh for the treatment of Saphenous Vein Graft (SVG) Coronary artery bypass grafting (CABG) versus SVG CABG without an eSVS™ Mesh. The eSVS™ Mesh External Saphenous Vein Support Trial is a prospective, multi-center, randomized, controlled trial enrolling up to 120 patients with multi-vessel coronary artery disease who require SVG CABG of the Right Coronary Artery and the Circumflex Artery due to atherosclerotic coronary artery disease. Patients will serve as their own control (patients will be randomized to either: SVG+eSVS™ Mesh at Right Coronary Artery and SVG at Circumflex Artery or SVG at Right Coronary Artery and SVG+eSVS™ Mesh at Circumflex Artery). Clinical follow-up assessments consisting of a physical exam, laboratory testing, medication review, and adverse event monitoring for all enrolled patients will be performed at 30 days, 6 months and 12 months. In addition, the 12 month follow-up assessment will include angiography. The investigational device being evaluated in this clinical trial is an External Saphenous Vein Support device, the eSVS™ Mesh. The eSVS™ Mesh is an extravascular prosthesis consisting of a highly flexible, semi-compliant knitted nitinol mesh tube that is placed over the patient's saphenous vein graft (SVG) during coronary artery bypass grafting (CABG). The eSVS™ Mesh is designed to: provide radial support to the vein to prevent graft dilatation reduce the vein graft diameter to more closely match target coronary artery diameter provide a more uniform lumen improve blood flow characteristics mitigate the development of intimal hyperplasia and graft stenosis The eSVS™ Mesh has compliance characteristics comparable to native internal thoracic arteries. Since the eSVS™ Mesh vascular prosthesis is made of nitinol, it is highly kink resistant.

Official Title
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The eSVS(TM)Mesh External Saphenous Vein Support Trial

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Device: eSVS, saphenous vein supporting mesh


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: require on-pump SVG CABG of the Right Coronary Artery and the Circumflex Artery due to atherosclerotic coronary artery disease, with ≥ 75% stenosis in each of these vessels have appropriately sized and accessible target coronary arteries, with a minimum diameter of 1.5 mm and a lack of calcification at the anastomotic site are able to give their informed written consent are ≥ 21 years of age Exclusion Criteria: no appropriate target coronary vessel discreet attachment of each SVG to the aorta is not possible (non-consecutive or jump grafts are excluded) concomitant non-CABG cardiac procedure prior peripheral vascular or cardiac surgery prior stroke history of atrial fibrillation diffuse peripheral vascular disease age > 80 LVEF < 30% at time of enrollment Insulin-dependent diabetes concurrent participation in another trial concomitant life-threatening disease likely to limit life expectancy to less than 2 years contra-indications to on-pump CABG with cardioplegic arrest (calcified aorta, calcified coronaries, small target vessels) emergency CABG surgery inability to tolerate or comply with normal post-surgical drug regimen (antiplatelet plus statin) taking warfarin or clopidogrel at the time of surgery inability to comply with required follow-ups, including angiography imaging methods patient is pregnant or intends on becoming pregnant in the next 12 months

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 80 Years

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Either the Circumflex Coronary Artery or the Right Coronary Artery will receive the mesh supported vein graft and the native saphenous vein as second and control graft. | Device: eSVS, saphenous vein supporting mesh<br>* Surgical coronary artery bypass grafting to the right coronary artery and the circumflex coronary artery with saphenous vein grafts, one will be supported by the eSVS(TM).<br>* Other names: eSVS™; Kips Bay Medical;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Efficacy Endpoint: The primary endpoint of the trial is percent stenosis of Study Vessels, assessed by angiography at 12 months following surgery |  | 12 months | 
| Primary Safety Endpoint: The occurrence of the composite of total mortality, stroke, MI (Q wave and non-Q wave), or coronary revascularization (i.e. coronary artery bypass surgery or percutaneous coronary intervention) at 30 days post surgery |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The occurrence of the composite of total mortality, stroke, MI (Q wave and non-Q wave), or coronary revascularization (i.e. coronary artery bypass surgery or percutaneous coronary intervention) at discharge, 6 months and 12 months post surgery |  | 12 months | 
| Per-patient incidence of vein graft failure/occlusion |  | 12 months | 
| Per-graft incidence of vein graft failure/occlusion |  | 12 months | 
| Rates of graft failure due to characterization of anastomotic site failure vs. graft failure |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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multi-vessel, therapy, surgery, CABG