The eMESH 1 Feasibility Study

Study Overview
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Brief Summary
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Multi-center, dual cohort (randomized and single vessel) study designed to demonstrate feasibility, initial safety and performance of the Kips Bay Medical, Inc. eSVS® Mesh as an external vein support device for use over saphenous vein grafts during coronary artery bypass surgery. In the Randomized Cohort, each study subject will receive a SVG without Mesh (control) and a SVG with the eSVS Mesh (treatment). In the Single Vessel Cohort, each study subject will receive one SVG with the eSVS Mesh.

Official Title
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A Multi-center, International Study of External Saphenous Vein Support Using eSVS® Mesh in CABG Surgery: The eMESH I Study

Conditions
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Atherosclerosis of Autologous Vein Coronary Artery Bypass Graft(s)

Intervention / Treatment
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* Device: eSVS Mesh treated saphenous vein graft
* Other: Control saphenous vein graft


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Randomized Cohort: Requires CABG surgery with a SVG to the right coronary artery (RCA) system AND the left circumflex artery (LCX) system with a ≥ 70% stenosis in each of the two systems. Single Vessel Cohort: Requires CABG surgery with a SVG to the RCA system or the LCX system with a > 70% stenosis in the system. Medial sternotomy with cardiopulmonary bypass (CPB) during surgery. Both saphenous vein graft length are adequate for planned intervention, vein outer diameter is between 3.6 mm and 7.0 mm and double wall thickness less than 1.4 mm. Agreement to post-procedure follow-up contact and testing (including follow-up coronary angiogram). Exclusion Criteria: Concomitant non-CABG cardiac procedure. Prior cardiac surgery (does not include percutaneous procedures). Cerebrovascular or transient ischemia attack within 30 days of the CABG procedure. Age > 85 years. Left ventricular ejection fraction ≤ 35%. Creatinine > 133 μmol/L (1.5 mg/dL) prior to CABG procedure or on chronic dialysis. STEMI within 7 days or total CK > 2 times the upper limit of normal prior to the CABG procedure. Both enrolled grafts will feed non-viable myocardial territory. Diffuse atherosclerotic disease (> 70%) distal to either of the enrolled target coronary arteries. Randomized Cohort: By visual estimate, the target coronary artery diameter of both the right coronary system and left circumflex system must be within 1.5mm of each other. Planned endarterectomy of the target coronary artery.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 85 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: eSVS Mesh treated saphenous vein graft<br>Each subject will be randomized to an eSVS Mesh treated SVG to the right or left coronary system. | Device: eSVS Mesh treated saphenous vein graft<br>* During coronary artery bypass graft surgery, one SVG will be randomized to be treated with eSVS Mesh and implanted in the right or left coronary system.<br>|
| Sham Comparator: Control saphenous vein graft<br>Each subject will be randomized to an untreated (no eSVS Mesh) SVG to the right or left coronary system. | Other: Control saphenous vein graft<br>* During coronary artery bypass graft surgery, one SVG will be randomized to be the control (no eSVS Mesh) and implanted in the right or left coronary system.<br>|
| Active Comparator: Single Vessel Treatment<br>Each subject with receive one SVG with eSVS Mesh either to the right or left coronary system. | Device: eSVS Mesh treated saphenous vein graft<br>* During coronary artery bypass graft surgery, one SVG will be randomized to be treated with eSVS Mesh and implanted in the right or left coronary system.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MACE | The rate of major adverse coronary events (MACE) defined as the rate of the composite of total mortality, MI (Q wave and non Q wave), and/or coronary target vessel revascularization (percutaneous coronary intervention or CABG). | 30 days | 
| SVG patency determined by angiography | Angiographic patency rate of the enrolled grafts defined as < 50% stenosis. | 6 months | 
| Technical success implanting eSVS Mesh | Technical success defined as successful placement of the eSVS Mesh on the saphenous vein and surgical implantation of the SVG. | intra-operative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MACCE and mediastinitis | MACE, MACCE, MI and all mortality rates through five years, mediastinitis rate through 6 months. | 5 years | 
| SVG patency determined by angiography | Angiographic patency rate of the enrolled grafts defined as < 75%. | 6 months | 
| Plaque burden | Plaque burden of the enrolled grafts as assessed by IVUS imaging (IVUS Sub-Study). | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CABG, SVG, nitinol mesh, external saphenous vein graft support