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Drug Eluting Balloon (DEB) vs Plain Old Balloon Angioplasty (POBA) in the Treatment of Failing Dialysis Access

Primary Purpose

Vascular Diseases, Kidney Diseases

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Advance PTX
Advance LP (Low Profile)
Paclitaxel (PTX)
Sponsored by
Skane University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vascular Diseases focused on measuring Haemodialysis, Fistula, Stenosis, Paclitaxel, Drug-eluting balloon, Angioplasty

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Active dialysis with a mature upper extremity dysfunctional haemodialysis access
  • Primary stenosis or nonstented restenosis in a native AV fistula or at graft-venous location
  • Adult (>18 years)
  • Target vessel diameter 3-8mm

Exclusion Criteria:

  • Thrombosed access
  • In stent restenosis
  • Pregnancy
  • Age less than 18 years

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    Drug Eluting Balloon (DEB)

    Plain Old Balloon Angioplasty (POBA)

    Arm Description

    Percutaneous Angioplasty in dysfunctional arteriovenous access, using Drug Eluting Balloon Technology. Drug: Paclitaxel (PTX). Name of Device: Advance PTX

    Percutaneous Angioplasty in dysfunctional arteriovenous access, using Plain Old Balloon Angioplasty. Drug: None. Name of Device: Advance LP (Low Profile)

    Outcomes

    Primary Outcome Measures

    Freedom from restenosis in treated vascular access
    Freedom from Restenosis and Target Lesion Revascularization (TLR) during 12 months follow up
    Stenosis or occlusion in treated vascular access
    Treated Denovo Stenosis or Occlusion during 12 months follow up, i.e a new stenosis >50%, not treated before in the study, and at another location in the vascular access circuit (upper arm haemodialysis access)
    Number of Participants with a vascular access in full clinical use for haemodialysis at 12 months
    Functional status of vascular access.

    Secondary Outcome Measures

    Full Information

    First Posted
    November 10, 2021
    Last Updated
    December 29, 2021
    Sponsor
    Skane University Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05173857
    Brief Title
    Drug Eluting Balloon (DEB) vs Plain Old Balloon Angioplasty (POBA) in the Treatment of Failing Dialysis Access
    Official Title
    Drug Eluting Balloon (DEB) vs Plain Old Balloon Angioplasty (POBA) for the Treatment of Failing Dialysis Access. A Prospective Randomized Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    March 1, 2014 (Actual)
    Primary Completion Date
    July 31, 2017 (Actual)
    Study Completion Date
    July 31, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Skane University Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Background Conventional percutaneous transluminal angioplasty is still considered standard treatment for treatment of dysfunctional haemodialysis fistulas and grafts. The most important drawback with this treatment is frequent restenosis leading to a high number of secondary procedures. There is conflicting evidence in the literature regarding primary or secondary treatment with drug eluting balloons (DEB). These balloons deliver Paclitaxel locally, which acts as an antiproliferative drug and may improve treatment outcomes. Methods This study was conducted as a prospective 1:1 randomized single centre clinical trial. Participants had primary or re-stenotic lesions in native upper extremity arteriovenous fistulas or at the graft-venous anastomosis. Patients were randomized to direct primary dilatation, with either a standard balloon or a DEB. The primary effectiveness endpoints were freedom from target lesion revascularization (TLR), access circuit revascularization or thrombosis, functional status of access circuit at 12 months. Secondary endpoints were procedural complications, procedural success, follow up survival and time to target lesion revascularization.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Vascular Diseases, Kidney Diseases
    Keywords
    Haemodialysis, Fistula, Stenosis, Paclitaxel, Drug-eluting balloon, Angioplasty

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    42 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Drug Eluting Balloon (DEB)
    Arm Type
    Active Comparator
    Arm Description
    Percutaneous Angioplasty in dysfunctional arteriovenous access, using Drug Eluting Balloon Technology. Drug: Paclitaxel (PTX). Name of Device: Advance PTX
    Arm Title
    Plain Old Balloon Angioplasty (POBA)
    Arm Type
    Placebo Comparator
    Arm Description
    Percutaneous Angioplasty in dysfunctional arteriovenous access, using Plain Old Balloon Angioplasty. Drug: None. Name of Device: Advance LP (Low Profile)
    Intervention Type
    Device
    Intervention Name(s)
    Advance PTX
    Intervention Description
    PTA in Dysfunctional Haemodialysis Access
    Intervention Type
    Device
    Intervention Name(s)
    Advance LP (Low Profile)
    Intervention Description
    Plain Old Balloon Angioplasty (POBA)
    Intervention Type
    Drug
    Intervention Name(s)
    Paclitaxel (PTX)
    Intervention Description
    Paclitaxel (PTX)
    Primary Outcome Measure Information:
    Title
    Freedom from restenosis in treated vascular access
    Description
    Freedom from Restenosis and Target Lesion Revascularization (TLR) during 12 months follow up
    Time Frame
    12 months
    Title
    Stenosis or occlusion in treated vascular access
    Description
    Treated Denovo Stenosis or Occlusion during 12 months follow up, i.e a new stenosis >50%, not treated before in the study, and at another location in the vascular access circuit (upper arm haemodialysis access)
    Time Frame
    12 months
    Title
    Number of Participants with a vascular access in full clinical use for haemodialysis at 12 months
    Description
    Functional status of vascular access.
    Time Frame
    12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Active dialysis with a mature upper extremity dysfunctional haemodialysis access Primary stenosis or nonstented restenosis in a native AV fistula or at graft-venous location Adult (>18 years) Target vessel diameter 3-8mm Exclusion Criteria: Thrombosed access In stent restenosis Pregnancy Age less than 18 years

    12. IPD Sharing Statement

    Learn more about this trial

    Drug Eluting Balloon (DEB) vs Plain Old Balloon Angioplasty (POBA) in the Treatment of Failing Dialysis Access

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