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

This study has been terminated.
(poor recruitment)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01200914
First Posted: September 14, 2010
Last Update Posted: May 12, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Dheeraj Rajan, University Health Network, Toronto
  Purpose

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.


Condition Intervention
Renal Failure Device: GORE VIABAHN® Endoprosthesis with Heparin Bioactive Surface Procedure: PTA alone without use of the GORE VIABAHN

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Placement of Covered Stents to Treat Hemodialysis Access Stenosis in the Cephalic Arch and Central Veins

Resource links provided by NLM:


Further study details as provided by Dheeraj Rajan, University Health Network, Toronto:

Primary Outcome Measures:
  • Target lesion primary patency at 3, 6, and 12 months [ Time Frame: 1 year ]

Secondary Outcome Measures:
  • 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 [ Time Frame: 1 year ]

Enrollment: 14
Study Start Date: January 2011
Study Completion Date: April 2015
Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 'PTA without use of the GORE VIABAHN'
Subjects randomized to 'PTA alone without use of the GORE VIABAHN' will receive the standard of care treatment which is Percutaneous Transluminal Angioplasty without the use of the 'GORE VIABAHN® Endoprosthesis with Heparin Bioactive Surface'
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'
Experimental: PTA with covered stent
Subjects randomized to PTA with covered stent will receive Percutaneous Transluminal Angioplasty followed by the delivery of a 'GORE VIABAHN® Endoprosthesis with Heparin Bioactive Surface' .
Device: GORE VIABAHN® Endoprosthesis with Heparin Bioactive Surface
The 'GORE VIABAHN® Endoprosthesis with Heparin Bioactive Surface' will be deployed at the brachiocephalic stenosis.
Other Name: Covered stent

Detailed Description:
This is a randomized, prospective, unblinded study with 1:1 randomization. Both groups will undergo PTA of stenotic lesion and patients will be randomized such that 50% will receive a covered stent in addition to the PTA. Patients will be followed at 3, 6, and 12 months post-procedure. Follow-up will be conducted with either angiographic and/or transonic measurements.
  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01200914


Locations
Canada, Ontario
Universtiy Health Network
Toronto, Ontario, Canada, M5G 2N2
Sponsors and Collaborators
University Health Network, Toronto
Investigators
Principal Investigator: Dheeraj Rajan, M.D. Physician
  More Information

Publications:

Responsible Party: Dheeraj Rajan, Head and Associate Professor, Division of Vascular & Interventional Radiology, University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT01200914     History of Changes
Other Study ID Numbers: GORE-001
First Submitted: September 10, 2010
First Posted: September 14, 2010
Last Update Posted: May 12, 2016
Last Verified: May 2016

Keywords provided by Dheeraj Rajan, University Health Network, Toronto:
Hemodialysis
Fistula
Angiograph
Angiogram

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Calcium heparin
Heparin
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action