Restenosis Following Paclitaxel Eluting Balloon Angioplasty of Hemodialysis Access Stenosis

November 14, 2014 updated by: University Health Network, Toronto

Local Delivery of Paclitaxel for Prevention of Restenosis in Hemodialysis Access

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2N2
        • University Health Network

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • Passeo-18 Lux (Biotronik)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Primary patency
Time Frame: at 6 months
at 6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Transonic blood flows
Time Frame: monthly for up to 6 months
monthly for up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Health Network, Toronto

Investigators

  • Principal Investigator: Kong Teng Tan, BCh MB, University Health Network, Toronto

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (Actual)

July 1, 2014

Study Completion (Actual)

July 1, 2014

Study Registration Dates

First Submitted

October 26, 2009

First Submitted That Met QC Criteria

October 26, 2009

First Posted (Estimate)

October 27, 2009

Study Record Updates

Last Update Posted (Estimate)

November 17, 2014

Last Update Submitted That Met QC Criteria

November 14, 2014

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ktt1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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