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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by University Health Network, Toronto
Sponsor:
Information provided by (Responsible Party):
Dheeraj Rajan, University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT01200914
First received: September 10, 2010
Last updated: January 17, 2014
Last verified: January 2014
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 University Health Network, Toronto:

Primary Outcome Measures:
  • Target lesion primary patency at 3, 6, and 12 months [ Time Frame: 1 year ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 140
Study Start Date: January 2011
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01200914

Contacts
Contact: Dheeraj Rajan, M.D. 416-340-4911/603-6276 Dheeraj.Rajan@uhn.on.ca

Locations
Canada, Ontario
Universtiy Health Network Recruiting
Toronto, Ontario, Canada, M5G 2N2
Contact: Dheeraj Rajan, MD    416-340-4911    dheeraj.rajan@uhn.ca   
Principal Investigator: Dheeraj Rajan, MD         
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
Study First Received: September 10, 2010
Last Updated: January 17, 2014
Health Authority: United States: Institutional Review Board
Canada: Health Canada

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

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Calcium heparin
Heparin
Anticoagulants
Cardiovascular Agents
Fibrin Modulating Agents
Fibrinolytic Agents
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014