The eMESH 1 Feasibility Study

Status:	Recruiting
Conditions:	Cardiology
Therapuetic Areas:	Cardiology / Vascular Diseases
Healthy:	No
Age Range:	21 - 85
Updated:	10/14/2017
Start Date:	August 2012
End Date:	June 2020
Contact:	Rebecca Wetterling
Email:	clinical@kipsbaymedical.com
Phone:	763-235-3540

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.

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.

We found this trial at

sites

General University Hospital

1 Na Bojišti
Prague, 120 00

Principal Investigator: Jaroslav Lindner, MD

Phone: +420 224 962 709

from

Prague,