The eMESH 1 Feasibility Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 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: August 19, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention Phase
Atherosclerosis of Autologous Vein Coronary Artery Bypass Graft(s)
Device: eSVS Mesh treated saphenous vein graft
Other: Control saphenous vein graft
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multi-center, International Study of External Saphenous Vein Support Using eSVS® Mesh in CABG Surgery: The eMESH I Study

Resource links provided by NLM:


Further study details as provided by Kips Bay Medical, Inc.:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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).


Estimated Enrollment: 120
Study Start Date: August 2012
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.
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.
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: Single Vessel Treatment
Each subject with receive one SVG with eSVS Mesh either to the right or left coronary system.
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.

  Eligibility

Ages Eligible for Study:   21 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01676376

Contacts
Contact: Rebecca Wetterling 763-235-3540 clinical@kipsbaymedical.com

Locations
United States, Georgia
Emory University Hospital Midtown Recruiting
Atlanta, Georgia, United States, 30308
Principal Investigator: John Puskas, MD         
Northeast Georgia Heart Center Recruiting
Gainesville, Georgia, United States, 30501
Principal Investigator: Alan Wolfe, MD         
United States, Minnesota
Mayo Clinic / St. Mary's Hospital Recruiting
Rochester, Minnesota, United States, 55905
Principal Investigator: Lyle Joyce, MD         
United States, New York
Lenox Hill Hospital Recruiting
New York, New York, United States, 10075
Contact: Nirav Patel, MD         
Principal Investigator: Nirav Patel, MD         
United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Joseph Sabik, MD         
Principal Investigator: Joseph Sabik, MD         
United States, Texas
St. Luke's Hospital / Texas Heart Institute Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Ross Reul, MD         
France
C.H.U. Dupuytren Recruiting
Limoges, France
Principal Investigator: Marc Laskar, MD         
Bordeaux University Hospital Recruiting
Pessac, France
Principal Investigator: Louis Labrousse, Prof. Dr.         
Italy
Lancisi Hospital Recruiting
Ancona, Italy
Contact: Giuseppe Rescigno, MD         
Principal Investigator: Giuseppe Rescigno, MD         
Heart Hospital - G. Monasterio Tuscany Foundation for Health & Research Recruiting
Massa, Italy
Principal Investigator: Marco Solinas, MD         
Sub-Investigator: Michele Murzi, MD         
Netherlands
Catharina Ziekenhuis Recruiting
Eindhoven, Netherlands
Principal Investigator: Erwin Tan, MD         
Switzerland
University Hospital of Bern Recruiting
Bern, Switzerland, 3010
Principal Investigator: Lars Englberger, Dr.         
United Kingdom
Royal Brompton Hospital Recruiting
London, United Kingdom, SW3 6NP
Principal Investigator: Anthony DeSouza, MD         
Sponsors and Collaborators
Kips Bay Medical, Inc.
Investigators
Principal Investigator: Lars Englberger, MD University of Bern
Principal Investigator: John Puskas, MD Emory University
  More Information

Additional Information:
No publications provided

Responsible Party: Kips Bay Medical, Inc.
ClinicalTrials.gov Identifier: NCT01676376     History of Changes
Other Study ID Numbers: 11016
Study First Received: August 21, 2012
Last Updated: August 19, 2014
Health Authority: Switzerland: Swissmedic
United States: Food and Drug Administration
France: Institutional Ethical Committee
Italy: Ethics Committee
England: NHS Health Research Authority

Keywords provided by Kips Bay Medical, Inc.:
CABG
SVG
nitinol mesh
external saphenous vein graft support

Additional relevant MeSH terms:
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 26, 2014