NCT01676376

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.

Trial Health

50
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Aug 2012

Longer than P75 for phase_1

Geographic Reach
7 countries

15 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

August 21, 2012

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 30, 2012

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
4.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
Last Updated

February 19, 2015

Status Verified

February 1, 2015

Enrollment Period

3.3 years

First QC Date

August 21, 2012

Last Update Submit

February 17, 2015

Conditions

Atherosclerosis of Autologous Vein Coronary Artery Bypass Graft(s)

Keywords

CABGSVGnitinol meshexternal saphenous vein graft support

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (3)

  • MACCE and mediastinitis

    5 years

  • SVG patency determined by angiography

    6 months

  • Plaque burden

    6 months

Study Arms (3)

eSVS Mesh treated saphenous vein graft

ACTIVE COMPARATOR

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

Control saphenous vein graft

SHAM COMPARATOR

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

Other: Control saphenous vein graft

Single Vessel Treatment

ACTIVE COMPARATOR

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

Device: eSVS Mesh treated saphenous vein graft

Interventions

eSVS Mesh treated saphenous vein graftDEVICE

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.

Single Vessel TreatmenteSVS Mesh treated saphenous vein graft
Control saphenous vein graftOTHER

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.

Control saphenous vein graft

Eligibility Criteria

Age21 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Emory University Hospital Midtown

Atlanta, Georgia, 30308, United States

RECRUITING

Northeast Georgia Heart Center

Gainesville, Georgia, 30501, United States

RECRUITING

Mayo Clinic / St. Mary's Hospital

Rochester, Minnesota, 55905, United States

RECRUITING

The Valley Hospital

Ridgewood, New Jersey, 07450, United States

RECRUITING

Lenox Hill Hospital

New York, New York, 10075, United States

RECRUITING

General University Hospital

Prague, Czechia

RECRUITING

Hospital na Homolce

Prague, Czechia

RECRUITING

University Hospital Kralovske Vinohrady

Prague, Czechia

ACTIVE NOT RECRUITING

C.H.U. Dupuytren

Limoges, France

RECRUITING

Bordeaux University Hospital

Pessac, France

RECRUITING

Lancisi Hospital

Ancona, Italy

RECRUITING

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

Massa, Italy

RECRUITING

Catharina Ziekenhuis

Eindhoven, Netherlands

RECRUITING

University Hospital of Bern

Bern, 3010, Switzerland

RECRUITING

Royal Brompton Hospital

London, SW3 6NP, United Kingdom

RECRUITING

Study Officials

  • Lars Englberger, MD

    University of Bern

    PRINCIPAL INVESTIGATOR

  • John Puskas, MD

    Emory University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rebecca Wetterling

CONTACT

763-235-3540clinical@kipsbaymedical.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 21, 2012

First Posted

August 30, 2012

Study Start

August 1, 2012

Primary Completion

December 1, 2015

Study Completion

June 1, 2020

Last Updated

February 19, 2015

Record last verified: 2015-02

Locations

NL(1)CZ(3)FR(2)IT(2)US(5)CH(1)GB(1)