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

January 6, 2011 updated by: American Access Care

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

140

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • New York
      • Bronx, New York, United States, 10461
        • Recruiting
        • American Access Care of Bronx
        • Contact:
        • Principal Investigator:
          • Abigail Falk, Dr.
      • Flushing, New York, United States, 11366
        • Recruiting
        • American Access Care of Queens
        • Contact:
          • Kiran Jotwani, MD
          • Phone Number: 718-820-9729
        • Principal Investigator:
          • Kiran Jotwani, MD
      • White Plains, New York, United States, 10601
        • Recruiting
        • Access Care Physicians of New York
        • Contact:
        • Principal Investigator:
          • Claudio Cantu, RPA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Hemodialysis patient with a mature forearm or upper arm access that was created > 2 months before enrollment in study.
  2. The patient is ≥ 18 years of age.
  3. The patient has a reasonable expectation of remaining on hemodialysis for 12 months.
  4. The patient or his/her legal guardian understands the study and is willing and able to comply with follow-up requirements.
  5. The patient or his/her legal guardian is willing to provide informed consent.
  6. The patient has lesions that meet the angiographic inclusion / exclusion criteria and induce clinical, hemodynamic or functional abnormality.

Exclusion Criteria:

  1. The patient has a known or suspected systemic infection.
  2. The patient has a known or suspected infection of the hemodialysis access and / or bacteremia.
  3. The patient is currently taking maintenance immunosuppressant medication such as rapamycin, mycophenolate or mycophenolic acid, prednisone (>10 mg per day), cyclosporine, tacrolimus, or cyclophosphamide.
  4. The patient has known bleeding disorder (e.g., hemophilia or von Willebrand's disease).
  5. The patient has known sensitivity to heparin.
  6. The patient is scheduled for a live donor kidney transplant.
  7. The patient is enrolled in another investigational study or another access maintenance trial
  8. The patient has comorbid conditions that may limit their ability to comply with the follow-up requirements
  9. Life expectancy is ≤ 24 months.
  10. The patient has an untreatable allergy to radiographic contrast material.
  11. The patient is pregnant.
  12. In the opinion of the operating physician, the patient's hemodialysis access circuit is unsuitable for endovascular treatment.
  13. The patient's access is planned to be abandoned within 1 year.
  14. The patient has indwelling catheters (dialysis, pacemakers, ports).
  15. The patient has a central vein stent that would lead to jailing of the internal jugular vein.
  16. The patient experiences angioplasty-induced venous rupture.
  17. The patient has a flow limiting dissection after angioplasty.
  18. The patient's hemodialysis access is thrombosed.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Percutaneous Transluminal Angioplasty (PTA) alone
Intervention: Procedure: PTA alone without use of the GORE VIABAHN
Other: PTA alone without use of the GORE VIABAHN
PTA alone with no stent used
Experimental: PTA with covered stent
GORE VIABAHN® Endoprosthesis with Heparin Bioactive Surface
Device: GORE VIABAHN® Endoprosthesis with Heparin Bioactive Surface
Covered stent produced by GORE VIABAHN
Other Names:
  • Covered stent

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary patency at 3, 6, and 12 months
Time Frame: 1 year
Target lesion primary patency at 3, 6, and 12 months
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Secondary patency at 3, 6, and 12 months
Time Frame: 1 year
Target lesion secondary patency at 3, 6, and 12 months, access circuit primary and secondary patency at 3, 6, and 12 months, anatomic, clinical, and procedural success. Adverse events through 1 month
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

American Access Care

Investigators

  • Principal Investigator: Abigail Falk, Dr., American Access Care Physician
  • Study Chair: Claudio Cantu, RPA, American Access Care Center Operations Manager

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (Anticipated)

October 1, 2011

Study Registration Dates

First Submitted

December 1, 2010

First Submitted That Met QC Criteria

January 6, 2011

First Posted (Estimate)

January 7, 2011

Study Record Updates

Last Update Posted (Estimate)

January 7, 2011

Last Update Submitted That Met QC Criteria

January 6, 2011

Last Verified

January 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GORE-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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