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The eSVS® Mesh Post-Marketing Trial

NCT01520311 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2016-06-29

No results posted yet for this study

Summary

The purpose of this study is to evaluate patency rates of the eSVS Mesh Saphenous Vein Graph (SVG) and control SVG at six and twenty-four months via coronary angiography and analyses of Duplex Sonography Results and coronary angiography and major cardiovascular or cerebrovascular event (MACCE)-Rate as well as analysis of preoperative great saphenous vein (GSV) duplex sonography and intra-operative GSV harvesting findings and procedure.

Conditions

Interventions

DEVICE

eSVS Mesh

Patients with multi-vessel coronary artery disease who require SVG CABG of the Right Coronary Artery and the Circumflex Artery due to atherosclerotic Coronary Artery Disease will serve as their own control. They will be randomized to either an SVG+eSVS Mesh to the RCA and an SVG to the Cx or an SVG to the RCA and an SVG+eSVS Mesh to the Cx.

Sponsors & Collaborators

  • University Hospital, Basel, Switzerland

    collaborator OTHER

  • Kips Bay Medical, Inc.

    lead INDUSTRY

Principal Investigators

  • Oliver Reuthebuch, PD Dr. med · University Hospital Basel, Clinic for Cardiac Surgery

  • Devdas Inderbitzin, MD · University Hospital Basel, Clinic for Cardiac Surgery

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2015-09-30
Completion
2015-09-30

Countries

  • Switzerland

Study Locations

More Related Trials

Entities

Diseases

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 NCT01520311 on ClinicalTrials.gov