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Restenosis Following Paclitaxel Eluting Balloon Angioplasty of Hemodialysis Access Stenosis

This study is not yet open for participant recruitment.
Verified January 2012 by University Health Network, Toronto
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT01001676
First received: October 26, 2009
Last updated: January 13, 2012
Last verified: January 2012
History of Changes
  Purpose

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 wall (intimal hyperplasia). The standard treatment is balloon dilatation. However, narrowing will inevitably recur in 2-3 months hence requiring further dilatation. Intimal hyperplasia also occurs in the heart and leg circulation. The drug paclitaxel has been used with great success in preventing intimal hyperplasia in these vessels following balloon dilatation. Administer locally, paclitaxel inhibits excess tissue growth in the vessel wall. The investigators believe that this drug will have similar effect in hemodialysis access..

Objective: To assess the effect of paclitaxel in hemodialysis access with narrowing. Paclitaxel is delivered by a paclitaxel-coated balloon. This balloon dilates the narrow segment and simultaneously delivers paclitaxel to the vessel wall.

Methodology: Patients with narrowed hemodialysis access are dilated with the paclitaxel-coated balloon or conventional balloon in randomized manner. The patency of the two groups are evaluated and compared at 6 months follow-up.

Potential benefit: Decrease number of balloon dilatations and hence hospital admissions, improve dialysis fistula function, and decrease overall economic cost.


Condition Intervention Phase
Renal Failure
 Device: Percutaneous Transluminal Angioplasty (PTA)
Device: Paclitaxel Eluting Balloon Angioplasty
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Local Delivery of Paclitaxel for Prevention of Restenosis in Hemodialysis Access

Resource links provided by NLM:

MedlinePlus related topics: Angioplasty Dialysis
Drug Information available for: Paclitaxel
U.S. FDA Resources

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

Primary Outcome Measures:
  • Primary patency [ Time Frame: at 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Transonic blood flows [ Time Frame: monthly for up to 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: February 2012
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Conventional Balloon Angioplasty Device: Percutaneous Transluminal Angioplasty (PTA)
Angioplasty with the use of Conventional balloon
Experimental: Drug Eluting Balloon Angioplasty Device: Paclitaxel Eluting Balloon Angioplasty
Angioplasty with the use of paclitaxel eluting balloon
Other Name: Passeo-18 Lux (Biotronik)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01001676

Contacts
Contact: Kong Teng Tan, BCh MB (416)340-4800 ext 6166 kongteng.tan@uhn.ca
Contact: Iris Zhong (416)946-4501 ext 4816 iris.zhong@uhn.ca

Locations
Canada, Ontario
University Health Network
Toronto, Ontario, Canada, M5G 2N2
Sponsors and Collaborators
University Health Network, Toronto
Investigators
Principal Investigator: Kong Teng Tan, BCh MB University Health Network, Toronto
  More Information

No publications provided

Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT01001676     History of Changes
Other Study ID Numbers: ktt1
Study First Received: October 26, 2009
Last Updated: January 13, 2012
Health Authority: Canada: Health Canada

Keywords provided by University Health Network, Toronto:
renal failure
Restenosis
Dialysis access
 Paclitaxel
Angioplasty
Intimal hyperplasia

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Paclitaxel
Tubulin Modulators
Antimitotic Agents
 Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 17, 2013