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Completed

NCT Number: NCT05173857

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

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.

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Key information

Conditions

Vascular Diseases Cardiovascular Diseases Constriction, Pathologic Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Fistula Kidney Diseases Male Urogenital Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Advance PTX

Device

PTA in Dysfunctional Haemodialysis Access

Advance LP (Low Profile)

Device

Plain Old Balloon Angioplasty (POBA)

Paclitaxel (PTX)

Drug

Paclitaxel (PTX)

Primary outcomes

  1. Freedom from restenosis in treated vascular access

    Time frame: 12 months

    Freedom from Restenosis and Target Lesion Revascularization (TLR) during 12 months follow up

  2. Stenosis or occlusion in treated vascular access

    Time frame: 12 months

    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)

  3. Number of Participants with a vascular access in full clinical use for haemodialysis at 12 months

    Time frame: 12 months

    Functional status of vascular access.

Sponsors and collaborators

Lead sponsor

Skane University Hospital

Other

Registry information

Official study title

Drug Eluting Balloon (DEB) vs Plain Old Balloon Angioplasty (POBA) for the Treatment of Failing Dialysis Access. A Prospective Randomized Trial

Important dates

Study start
2014
Primary completion
2017
Study completion
2018
First posted
Dec 30, 2021
Registry last updated
Jan 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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