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GORE VIABAHN Endoprosthesis Versus Percutaneous Transluminal Angioplasty (PTA) to Revise AV Grafts in Hemodialysis

NCT00737672 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 293

Last updated 2014-10-21

Study results available
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Summary

The objective of the study is to establish efficacy and safety of the GORE VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface when used to revise arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis.

Conditions

  • Renal Failure
  • Hemodialysis

Interventions

DEVICE

GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface

Deployment of investigational stent graft at the venous anastomosis

PROCEDURE

Percutaneous Transluminal Angioplasty

Percutaneous Transluminal Angioplasty at the venous anastomosis

Sponsors & Collaborators

  • W.L.Gore & Associates

    lead INDUSTRY

Principal Investigators

  • Tom Vesely, MD · Vascular Access Center; Frontenac, MO

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-09-30
Primary Completion
2011-05-31
Completion
2013-06-30

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 NCT00737672 on ClinicalTrials.gov