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GORE VIABAHN ENDOPROSTHESIS Peripheral Vascular Disease Study

NCT00228384 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 148

Last updated 2012-06-04

Study results available
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Summary

To evaluate the performance of the GORE VIABAHN® Endoprosthesis compared to a bare nitinol stent for the treatment of superficial femoral artery (SFA) occlusive disease in long lesions.

Conditions

  • Peripheral Vascular Diseases

Interventions

DEVICE

GORE VIABAHN Endoprosthesis

Implantation

DEVICE

Bare Nitinol Stent

Implantation

Sponsors & Collaborators

  • W.L.Gore & Associates

    lead INDUSTRY

Principal Investigators

  • Gary Ansel, MD · Midwest Cardiology

  • Patrick Geraghty, MD · Washington University School of Medicine

  • Mark Mewissen, MD · St. Luke's Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-09-30
Primary Completion
2011-01-31
Completion
2011-01-31

Countries

  • United States

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 NCT00228384 on ClinicalTrials.gov