The eMESH 1 Feasibility Study

Overview

About this 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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location	Status
Rochester, Minn. Mayo Clinic principal investigator Lyle Joyce, M.D., Ph.D.	Closed for enrollment

Mayo Clinic Location

Status

Rochester, Minn.

Mayo Clinic principal investigator

Lyle Joyce, M.D., Ph.D.

Closed for enrollment

More information

Publications

Publications are currently not available

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