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The eMESH 1 Feasibility Study

NCT01676376 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2015-02-19

No results posted yet for this study

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.

Conditions

  • Atherosclerosis of Autologous Vein Coronary Artery Bypass Graft(s)

Interventions

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.

Sponsors & Collaborators

  • Kips Bay Medical, Inc.

    lead INDUSTRY

Principal Investigators

  • Lars Englberger, MD · University of Bern

  • John Puskas, MD · Emory University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-08-31
Primary Completion
2015-12-31
Completion
2020-06-30

Countries

  • United States
  • Czechia
  • France
  • Italy
  • Netherlands
  • Switzerland
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01676376 on ClinicalTrials.gov