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

NCT01271881 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2011-01-07

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

  • Hemodialysis

Interventions

OTHER

PTA alone without use of the GORE VIABAHN

PTA alone with no stent used

DEVICE

GORE VIABAHN® Endoprosthesis with Heparin Bioactive Surface

Covered stent produced by GORE VIABAHN

Sponsors & Collaborators

  • American Access Care

    lead OTHER

Principal Investigators

  • Abigail Falk, Dr. · American Access Care Physician

  • Claudio Cantu, RPA · American Access Care Center Operations Manager

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-10-31
Primary Completion
2011-10-31

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 NCT01271881 on ClinicalTrials.gov