The eMESH 1 Feasibility Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Kips Bay Medical, Inc.
Sponsor:
Information provided by (Responsible Party):
Kips Bay Medical, Inc.
ClinicalTrials.gov Identifier:
NCT01676376
First received: August 21, 2012
Last updated: February 27, 2014
Last verified: February 2014

August 21, 2012
February 27, 2014
August 2012
December 2014   (final data collection date for primary outcome measure)
  • MACE [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    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).
  • SVG patency determined by angiography [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Angiographic patency rate of the enrolled grafts defined as < 50% stenosis.
  • Technical success implanting eSVS Mesh [ Time Frame: intra-operative ] [ Designated as safety issue: No ]
    Technical success defined as successful placement of the eSVS Mesh on the saphenous vein and surgical implantation of the SVG.
Not Provided
Complete list of historical versions of study NCT01676376 on ClinicalTrials.gov Archive Site
  • MACCE and mediastinitis [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    MACE, MACCE, MI and all mortality rates through five years, mediastinitis rate through 6 months.
  • SVG patency determined by angiography [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Angiographic patency rate of the enrolled grafts defined as < 75%.
  • Plaque burden [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Plaque burden of the enrolled grafts as assessed by IVUS imaging (IVUS Sub-Study).
Not Provided
Not Provided
Not Provided
 
The eMESH 1 Feasibility Study
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.

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Atherosclerosis of Autologous Vein Coronary Artery Bypass Graft(s)
  • Device: eSVS Mesh treated saphenous vein graft
    During coronary artery bypass graft surgery, one SVG will be randomized to be treated with eSVS Mesh and implanted in the right or left coronary system.
  • Other: Control saphenous vein graft
    During coronary artery bypass graft surgery, one SVG will be randomized to be the control (no eSVS Mesh) and implanted in the right or left coronary system.
  • Active Comparator: eSVS Mesh treated saphenous vein graft
    Each subject will be randomized to an eSVS Mesh treated SVG to the right or left coronary system.
    Intervention: Device: eSVS Mesh treated saphenous vein graft
  • Sham Comparator: Control saphenous vein graft
    Each subject will be randomized to an untreated (no eSVS Mesh) SVG to the right or left coronary system.
    Intervention: Other: Control saphenous vein graft
  • Active Comparator: Single Vessel Treatment
    Each subject with receive one SVG with eSVS Mesh either to the right or left coronary system.
    Intervention: Device: eSVS Mesh treated saphenous vein graft
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
120
December 2019
December 2014   (final data collection date for primary outcome measure)

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.
Both
21 Years to 80 Years
No
Contact: Rebecca Wetterling 763-235-3540 clinical@kipsbaymedical.com
United States,   France,   Italy,   Netherlands,   Switzerland,   United Kingdom
 
NCT01676376
11016
Yes
Kips Bay Medical, Inc.
Kips Bay Medical, Inc.
Not Provided
Principal Investigator: Lars Englberger, MD University of Bern
Principal Investigator: John Puskas, MD Emory University
Kips Bay Medical, Inc.
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP