The eMESH 1 Feasibility Study (eMESH 1)

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.

Study Overview

• Status: Unknown
• Conditions: Atherosclerosis of Autologous Vein Coronary Artery Bypass Graft(s)
• Intervention / Treatment: Device: eSVS Mesh treated saphenous vein graft; Other: Control saphenous vein graft

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Czech Republic
  • Prague, Czech Republic
    • Recruiting
    • General University Hospital
    • Contact: Jaroslav Lindner, MD; Phone Number: +420 224 962 709
    • Principal Investigator: Jaroslav Lindner, MD
  • Prague, Czech Republic
    • Recruiting
    • Hospital Na Homolce
    • Contact: Ivo Skalsky, MD; Phone Number: +420257273209
    • Principal Investigator: Ivo Skalsky, MD
  • Prague, Czech Republic
    • Active, not recruiting
    • University Hospital Královské Vinohrady
• France
  • Limoges, France
    • Recruiting
    • C.H.U. Dupuytren
    • Principal Investigator: Marc Laskar, MD
  • Pessac, France
    • Recruiting
    • Bordeaux University Hospital
    • Principal Investigator: Louis Labrousse, Prof. Dr.
• Italy
  • Ancona, Italy
    • Recruiting
    • Lancisi Hospital
    • Contact: Giuseppe Rescigno, MD
    • Principal Investigator: Giuseppe Rescigno, MD
  • Massa, Italy
    • Recruiting
    • Heart Hospital - G. Monasterio Tuscany Foundation for Health & Research
    • Principal Investigator: Marco Solinas, MD
    • Sub-Investigator: Michele Murzi, MD
• Netherlands
  • Eindhoven, Netherlands
    • Recruiting
    • Catharina Ziekenhuis
    • Principal Investigator: Erwin Tan, MD
• Switzerland
  • Bern, Switzerland, 3010
    • Recruiting
    • University Hospital of Bern
    • Principal Investigator: Lars Englberger, Dr.
• United Kingdom
  • London, United Kingdom, SW3 6NP
    • Recruiting
    • Royal Brompton Hospital
    • Principal Investigator: Anthony DeSouza, MD
• United States
  • Georgia
    • Atlanta, Georgia, United States, 30308
      • Recruiting
      • Emory University Hospital Midtown
      • Principal Investigator: Omar Lattouf, MD
    • Gainesville, Georgia, United States, 30501
      • Recruiting
      • Northeast Georgia Heart Center
      • Principal Investigator: Alan Wolfe, MD
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Recruiting
      • Mayo Clinic / St. Mary's Hospital
      • Principal Investigator: Lyle Joyce, MD
  • New Jersey
    • Ridgewood, New Jersey, United States, 07450
      • Recruiting
      • The Valley Hospital
      • Principal Investigator: Juan Grau, MD
      • Contact: Kimberly Michel, RN; Phone Number: 2745 201-447-8000
  • New York
    • New York, New York, United States, 10075
      • Recruiting
      • Lenox Hill Hospital
      • Contact: Nirav Patel, MD
      • Principal Investigator: Nirav Patel, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MACE	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).	30 days
SVG patency determined by angiography	Angiographic patency rate of the enrolled grafts defined as < 50% stenosis.	6 months
Technical success implanting eSVS Mesh	Technical success defined as successful placement of the eSVS Mesh on the saphenous vein and surgical implantation of the SVG.	intra-operative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MACCE and mediastinitis	MACE, MACCE, MI and all mortality rates through five years, mediastinitis rate through 6 months.	5 years
SVG patency determined by angiography	Angiographic patency rate of the enrolled grafts defined as < 75%.	6 months
Plaque burden	Plaque burden of the enrolled grafts as assessed by IVUS imaging (IVUS Sub-Study).	6 months

Collaborators and Investigators

• Sponsor: Kips Bay Medical, Inc.
• Investigators: Principal Investigator: Lars Englberger, MD, University of Bern; Principal Investigator: John Puskas, MD, Emory University

Study record dates

Study Major Dates

• Study Start: August 1, 2012
• Primary Completion (Anticipated): December 1, 2015
• Study Completion (Anticipated): June 1, 2020

Study Registration Dates

• First Submitted: August 21, 2012
• First Submitted That Met QC Criteria: August 28, 2012
• First Posted (Estimate): August 30, 2012

Study Record Updates

• Last Update Posted (Estimate): February 19, 2015
• Last Update Submitted That Met QC Criteria: February 17, 2015
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Keywords: CABG; SVG; nitinol mesh; external saphenous vein graft support
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis
• Other Study ID Numbers: 11016 (DAIDS ES Registry Number)