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Status:

TERMINATED

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

Lead Sponsor:

University Health Network, Toronto

Conditions:

Renal Failure

Eligibility:

All Genders

18+ years

Phase:

NA

Brief 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 ...

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...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

January 1 2011

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

April 1 2015

Estimated Enrollment :

14 Patients enrolled

Trial Details

Trial ID

NCT01200914

Start Date

January 1 2011

End Date

April 1 2015

Last Update

May 12 2016

Active Locations (1)

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1

Universtiy Health Network

Toronto, Ontario, Canada, M5G 2N2