Atherosclerosis of Autologous Vein Coronary Artery Bypass Graft(s) Clinical Trial
— eMESH 1Official title:
A Multi-center, International Study of External Saphenous Vein Support Using eSVS® Mesh in CABG Surgery: The eMESH I Study
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.
| Status | Recruiting |
| Enrollment | 120 |
| Est. completion date | June 2020 |
| Est. primary completion date | December 2015 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 21 Years to 85 Years |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| Czech Republic | General University Hospital | Prague | |
| Czech Republic | Hospital na Homolce | Prague | |
| Czech Republic | University Hospital Kralovske Vinohrady | Prague | |
| France | C.H.U. Dupuytren | Limoges | |
| France | Bordeaux University Hospital | Pessac | |
| Italy | Lancisi Hospital | Ancona | |
| Italy | Heart Hospital - G. Monasterio Tuscany Foundation for Health & Research | Massa | |
| Netherlands | Catharina Ziekenhuis | Eindhoven | |
| Switzerland | University Hospital of Bern | Bern | |
| United Kingdom | Royal Brompton Hospital | London | |
| United States | Emory University Hospital Midtown | Atlanta | Georgia |
| United States | Northeast Georgia Heart Center | Gainesville | Georgia |
| United States | Lenox Hill Hospital | New York | New York |
| United States | The Valley Hospital | Ridgewood | New Jersey |
| United States | Mayo Clinic / St. Mary's Hospital | Rochester | Minnesota |
| Lead Sponsor | Collaborator |
|---|---|
| Kips Bay Medical, Inc. |
United States, Czech Republic, France, Italy, Netherlands, Switzerland, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | |
| Primary | SVG patency determined by angiography | Angiographic patency rate of the enrolled grafts defined as < 50% stenosis. | 6 months | |
| Primary | 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 | MACCE and mediastinitis | MACE, MACCE, MI and all mortality rates through five years, mediastinitis rate through 6 months. | 5 years | |
| Secondary | SVG patency determined by angiography | Angiographic patency rate of the enrolled grafts defined as < 75%. | 6 months | |
| Secondary | Plaque burden | Plaque burden of the enrolled grafts as assessed by IVUS imaging (IVUS Sub-Study). | 6 months |