A Multi-center, International Study of External Saphenous Vein Support Using eSVS® Mesh in CABG Surgery: The eMESH I Study
Trial status: Open for Enrollment
Why is this study being done?
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.
Who is eligible to participate?
- 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).
- 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.