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Covered Stents to Treat Hemodialysis Access Stenoses in the Cephalic Arch and Central Veins

NCT01200914 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2016-05-12

No results posted yet for this study

Summary

Balloon angioplasty is used to open up a narrowing that forms in hemodialysis fistula. Two areas of particular problems are the terminal portion of the cephalic vein near the shoulder and the central veins in the chest. Although angioplasty is standard of care the treated narrowed segments of vein mostly renarrow within 3 months requiring retreatment to keep your dialysis access functional. Recently there has been introduction of a new technology called a covered stent graft. Initial studies suggest that placing this device across the area of narrowing leads to dialysis access staying open longer and needing less angioplasty treatments.

This study is designed to compare angioplasty (standard of care) versus using a covered stent graft. The investigators will then look at the dialysis records and future fistulograms to see if there is decreased flow through the fistula at 3, 6 and 12 months after the initial procedure.

Conditions

  • Renal Failure

Interventions

DEVICE

GORE VIABAHN® Endoprosthesis with Heparin Bioactive Surface

The 'GORE VIABAHN® Endoprosthesis with Heparin Bioactive Surface' will be deployed at the brachiocephalic stenosis.

PROCEDURE

PTA alone without use of the GORE VIABAHN

Subject will receive standard of care PTA alone at the brachiocephalic stenosis without deployment of the'GORE VIABAHN® Endoprosthesis with Heparin Bioactive Surface'

Sponsors & Collaborators

  • University Health Network, Toronto

    lead OTHER

Principal Investigators

  • Dheeraj Rajan, M.D. · Physician

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2015-04-30
Completion
2015-04-30

Countries

  • Canada

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 NCT01200914 on ClinicalTrials.gov