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The eMESH 1 Feasibility Study (eMESH 1)

Primary Purpose

Atherosclerosis of Autologous Vein Coronary Artery Bypass Graft(s)

Status
Unknown status
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
eSVS Mesh treated saphenous vein graft
Control saphenous vein graft
Sponsored by
Kips Bay Medical, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atherosclerosis of Autologous Vein Coronary Artery Bypass Graft(s) focused on measuring CABG, SVG, nitinol mesh, external saphenous vein graft support

Eligibility Criteria

21 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Emory University Hospital MidtownRecruiting
  • Northeast Georgia Heart CenterRecruiting
  • Mayo Clinic / St. Mary's HospitalRecruiting
  • The Valley HospitalRecruiting
  • Lenox Hill HospitalRecruiting
  • General University HospitalRecruiting
  • Hospital na HomolceRecruiting
  • University Hospital Kralovske Vinohrady
  • C.H.U. DupuytrenRecruiting
  • Bordeaux University HospitalRecruiting
  • Lancisi HospitalRecruiting
  • Heart Hospital - G. Monasterio Tuscany Foundation for Health & ResearchRecruiting
  • Catharina ZiekenhuisRecruiting
  • University Hospital of BernRecruiting
  • Royal Brompton HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Sham Comparator

Active Comparator

Arm Label

eSVS Mesh treated saphenous vein graft

Control saphenous vein graft

Single Vessel Treatment

Arm Description

Each subject will be randomized to an eSVS Mesh treated SVG to the right or left coronary system.

Each subject will be randomized to an untreated (no eSVS Mesh) SVG to the right or left coronary system.

Each subject with receive one SVG with eSVS Mesh either to the right or left coronary system.

Outcomes

Primary Outcome Measures

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).
SVG patency determined by angiography
Angiographic patency rate of the enrolled grafts defined as < 50% stenosis.
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.

Secondary Outcome Measures

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

Full Information

First Posted
August 21, 2012
Last Updated
February 17, 2015
Sponsor
Kips Bay Medical, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01676376
Brief Title
The eMESH 1 Feasibility Study
Acronym
eMESH 1
Official Title
A Multi-center, International Study of External Saphenous Vein Support Using eSVS® Mesh in CABG Surgery: The eMESH I Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Unknown status
Study Start Date
August 2012 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
June 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kips Bay Medical, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atherosclerosis of Autologous Vein Coronary Artery Bypass Graft(s)
Keywords
CABG, SVG, nitinol mesh, external saphenous vein graft support

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
eSVS Mesh treated saphenous vein graft
Arm Type
Active Comparator
Arm Description
Each subject will be randomized to an eSVS Mesh treated SVG to the right or left coronary system.
Arm Title
Control saphenous vein graft
Arm Type
Sham Comparator
Arm Description
Each subject will be randomized to an untreated (no eSVS Mesh) SVG to the right or left coronary system.
Arm Title
Single Vessel Treatment
Arm Type
Active Comparator
Arm Description
Each subject with receive one SVG with eSVS Mesh either to the right or left coronary system.
Intervention Type
Device
Intervention Name(s)
eSVS Mesh treated saphenous vein graft
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Control saphenous vein graft
Intervention Description
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.
Primary Outcome Measure Information:
Title
MACE
Description
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).
Time Frame
30 days
Title
SVG patency determined by angiography
Description
Angiographic patency rate of the enrolled grafts defined as < 50% stenosis.
Time Frame
6 months
Title
Technical success implanting eSVS Mesh
Description
Technical success defined as successful placement of the eSVS Mesh on the saphenous vein and surgical implantation of the SVG.
Time Frame
intra-operative
Secondary Outcome Measure Information:
Title
MACCE and mediastinitis
Description
MACE, MACCE, MI and all mortality rates through five years, mediastinitis rate through 6 months.
Time Frame
5 years
Title
SVG patency determined by angiography
Description
Angiographic patency rate of the enrolled grafts defined as < 75%.
Time Frame
6 months
Title
Plaque burden
Description
Plaque burden of the enrolled grafts as assessed by IVUS imaging (IVUS Sub-Study).
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rebecca Wetterling
Phone
763-235-3540
Email
clinical@kipsbaymedical.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lars Englberger, MD
Organizational Affiliation
University of Bern
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
John Puskas, MD
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emory University Hospital Midtown
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Omar Lattouf, MD
Facility Name
Northeast Georgia Heart Center
City
Gainesville
State/Province
Georgia
ZIP/Postal Code
30501
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alan Wolfe, MD
Facility Name
Mayo Clinic / St. Mary's Hospital
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lyle Joyce, MD
Facility Name
The Valley Hospital
City
Ridgewood
State/Province
New Jersey
ZIP/Postal Code
07450
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kimberly Michel, RN
Phone
201-447-8000
Ext
2745
First Name & Middle Initial & Last Name & Degree
Juan Grau, MD
Facility Name
Lenox Hill Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10075
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nirav Patel, MD
First Name & Middle Initial & Last Name & Degree
Nirav Patel, MD
Facility Name
General University Hospital
City
Prague
Country
Czech Republic
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jaroslav Lindner, MD
Phone
+420 224 962 709
First Name & Middle Initial & Last Name & Degree
Jaroslav Lindner, MD
Facility Name
Hospital na Homolce
City
Prague
Country
Czech Republic
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ivo Skalsky, MD
Phone
+420257273209
First Name & Middle Initial & Last Name & Degree
Ivo Skalsky, MD
Facility Name
University Hospital Kralovske Vinohrady
City
Prague
Country
Czech Republic
Individual Site Status
Active, not recruiting
Facility Name
C.H.U. Dupuytren
City
Limoges
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marc Laskar, MD
Facility Name
Bordeaux University Hospital
City
Pessac
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Louis Labrousse, Prof. Dr.
Facility Name
Lancisi Hospital
City
Ancona
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Giuseppe Rescigno, MD
First Name & Middle Initial & Last Name & Degree
Giuseppe Rescigno, MD
Facility Name
Heart Hospital - G. Monasterio Tuscany Foundation for Health & Research
City
Massa
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marco Solinas, MD
First Name & Middle Initial & Last Name & Degree
Michele Murzi, MD
Facility Name
Catharina Ziekenhuis
City
Eindhoven
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Erwin Tan, MD
Facility Name
University Hospital of Bern
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lars Englberger, Dr.
Facility Name
Royal Brompton Hospital
City
London
ZIP/Postal Code
SW3 6NP
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anthony DeSouza, MD

12. IPD Sharing Statement

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The eMESH 1 Feasibility Study

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