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Restenosis Following Paclitaxel Eluting Balloon Angioplasty of Hemodialysis Access Stenosis

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. Identifier: NCT01001676
Recruitment Status : Completed
First Posted : October 27, 2009
Last Update Posted : November 17, 2014
Information provided by (Responsible Party):
University Health Network, Toronto

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 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 or disease Intervention/treatment Phase
Renal Failure Device: Percutaneous Transluminal Angioplasty (PTA) Device: Paclitaxel Eluting Balloon Angioplasty Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Local Delivery of Paclitaxel for Prevention of Restenosis in Hemodialysis Access
Study Start Date : February 2012
Actual Primary Completion Date : July 2014
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Angioplasty Dialysis
Drug Information available for: Paclitaxel

Arm Intervention/treatment
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)

Primary Outcome Measures :
  1. Primary patency [ Time Frame: at 6 months ]

Secondary Outcome Measures :
  1. Transonic blood flows [ Time Frame: monthly for up to 6 months ]

Information from the National Library of Medicine

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

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

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 identifier (NCT number): NCT01001676

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Canada, Ontario
University Health Network
Toronto, Ontario, Canada, M5G 2N2
Sponsors and Collaborators
University Health Network, Toronto
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Principal Investigator: Kong Teng Tan, BCh MB University Health Network, Toronto
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Responsible Party: University Health Network, Toronto Identifier: NCT01001676    
Other Study ID Numbers: ktt1
First Posted: October 27, 2009    Key Record Dates
Last Update Posted: November 17, 2014
Last Verified: January 2012
Keywords provided by University Health Network, Toronto:
renal failure
Dialysis access
Intimal hyperplasia
Additional relevant MeSH terms:
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Renal Insufficiency
Kidney Diseases
Urologic Diseases
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action