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

NCT05173857 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2022-01-14

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

Advance PTX

PTA in Dysfunctional Haemodialysis Access

DEVICE

Advance LP (Low Profile)

Plain Old Balloon Angioplasty (POBA)

DRUG

Paclitaxel (PTX)

Paclitaxel (PTX)

Sponsors & Collaborators

  • Skane University Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-01
Primary Completion
2017-07-31
Completion
2018-07-31

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05173857 on ClinicalTrials.gov