Status:

COMPLETED

Restenosis Following Paclitaxel Eluting Balloon Angioplasty of Hemodialysis Access Stenosis

Lead Sponsor:

University Health Network, Toronto

Conditions:

Renal Failure

Eligibility:

All Genders

18+ years

Phase:

PHASE2

Brief Summary

Introduction: Narrowing of the draining vein occurs in \>50% of hemodialysis fistula and left untreated will lead to loss of access. The narrowing is due to excessive growth of tissue in the vessel wa...

Eligibility Criteria

Inclusion

  • Hemodialysis access located in the forearm or upper arm
  • Patient with clinical or hemodynamic evidence of graft dysfunction
  • Hemodialysis access is \> 3 months old

Exclusion

  • Intervention of the vascular access circuit within the past 30 days
  • Thrombosed/clotted access
  • Evidence of systemic infection or a local infection associated with the graft
  • Positive pregnancy test within 7 days before enrolment
  • Patient is scheduled for a kidney transplant

Key Trial Info

Start Date :

February 1 2012

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

July 1 2014

Estimated Enrollment :

32 Patients enrolled

Trial Details

Trial ID

NCT01001676

Start Date

February 1 2012

End Date

July 1 2014

Last Update

November 17 2014

Active Locations (1)

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1

University Health Network

Toronto, Ontario, Canada, M5G 2N2