The eMESH 1 Feasibility Study

Status unconfirmed · Phase 1/Phase 2

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

In brief

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.

Key facts

Study ID

NCT01676376

Run by

Kips Bay Medical, Inc.

People needed

120

Starts

2012-08-01

Expected to finish

2020-06-01

Last updated by the study team

2015-02-19

Who can join

Age: 21 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• Emory University Hospital Midtown — Atlanta, Georgia, United States (enrolling)
• Northeast Georgia Heart Center — Gainesville, Georgia, United States (enrolling)
• Mayo Clinic / St. Mary's Hospital — Rochester, Minnesota, United States (enrolling)
• The Valley Hospital — Ridgewood, New Jersey, United States (enrolling)
• Lenox Hill Hospital — New York, New York, United States (enrolling)
• General University Hospital — Prague, Czechia (enrolling)
• Hospital na Homolce — Prague, Czechia (enrolling)
• Royal Brompton Hospital — London, United Kingdom (enrolling)
• C.H.U. Dupuytren — Limoges, France (enrolling)
• Bordeaux University Hospital — Pessac, France (enrolling)
• Lancisi Hospital — Ancona, Italy (enrolling)
• Heart Hospital - G. Monasterio Tuscany Foundation for Health & Research — Massa, Italy (enrolling)
• Catharina Ziekenhuis — Eindhoven, Netherlands (enrolling)
• University Hospital of Bern — Bern, Switzerland (enrolling)
• University Hospital Kralovske Vinohrady — Prague, Czechia

Full record on ClinicalTrials.gov

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