The eMESH 1 Feasibility Study

Last updated: February 17, 2015
Sponsor: Kips Bay Medical, Inc.
Overall Status: Active - Recruiting

Phase

1/2

Condition

Atherosclerosis

Treatment

N/A

Clinical Study ID

NCT01676376
11016
  • Ages 21-85
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 ofthe two systems.

  • Single Vessel Cohort: Requires CABG surgery with a SVG to the RCA system or the LCXsystem 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 outerdiameter 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-upcoronary angiogram).

Exclusion

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 CABGprocedure.

  • Both enrolled grafts will feed non-viable myocardial territory.

  • Diffuse atherosclerotic disease (> 70%) distal to either of the enrolled targetcoronary arteries.

  • Randomized Cohort: By visual estimate, the target coronary artery diameter of both theright coronary system and left circumflex system must be within 1.5mm of each other.

  • Planned endarterectomy of the target coronary artery.

Study Design

Total Participants: 120
Study Start date:
August 01, 2012
Estimated Completion Date:
June 30, 2020

Connect with a study center

  • General University Hospital

    Prague,
    Czech Republic

    Active - Recruiting

  • Hospital na Homolce

    Prague,
    Czech Republic

    Active - Recruiting

  • University Hospital Kralovske Vinohrady

    Prague,
    Czech Republic

    Site Not Available

  • C.H.U. Dupuytren

    Limoges,
    France

    Active - Recruiting

  • Bordeaux University Hospital

    Pessac,
    France

    Active - Recruiting

  • Brothers of Mercy Hospital

    Trier,
    Germany

    Site Not Available

  • Lancisi Hospital

    Ancona,
    Italy

    Active - Recruiting

  • Heart Hospital - G. Monasterio Tuscany Foundation for Health & Research

    Massa,
    Italy

    Active - Recruiting

  • Catharina Ziekenhuis

    Eindhoven,
    Netherlands

    Active - Recruiting

  • University Hospital of Bern

    Bern, 3010
    Switzerland

    Active - Recruiting

  • Royal Brompton Hospital

    London, SW3 6NP
    United Kingdom

    Active - Recruiting

  • Emory University Hospital Midtown

    Atlanta, Georgia 30308
    United States

    Active - Recruiting

  • Northeast Georgia Heart Center

    Gainesville, Georgia 30501
    United States

    Active - Recruiting

  • Mayo Clinic / St. Mary's Hospital

    Rochester, Minnesota 55905
    United States

    Active - Recruiting

  • The Valley Hospital

    Ridgewood, New Jersey 07450
    United States

    Active - Recruiting

  • Lenox Hill Hospital

    New York, New York 10075
    United States

    Active - Recruiting

  • Cleveland Clinic

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • St. Luke's Hospital / Texas Heart Institute

    Houston, Texas 77030
    United States

    Site Not Available

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