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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-01

Study Completion Date

2018-07-31

Brief Summary

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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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Detailed Description

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Conditions

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Vascular Diseases Kidney Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Drug Eluting Balloon (DEB)

Percutaneous Angioplasty in dysfunctional arteriovenous access, using Drug Eluting Balloon Technology.

Drug: Paclitaxel (PTX). Name of Device: Advance PTX

Group Type ACTIVE_COMPARATOR

Advance PTX

Intervention Type DEVICE

PTA in Dysfunctional Haemodialysis Access

Paclitaxel (PTX)

Intervention Type DRUG

Paclitaxel (PTX)

Plain Old Balloon Angioplasty (POBA)

Percutaneous Angioplasty in dysfunctional arteriovenous access, using Plain Old Balloon Angioplasty.

Drug: None. Name of Device: Advance LP (Low Profile)

Group Type PLACEBO_COMPARATOR

Advance LP (Low Profile)

Intervention Type DEVICE

Plain Old Balloon Angioplasty (POBA)

Interventions

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Advance PTX

PTA in Dysfunctional Haemodialysis Access

Intervention Type DEVICE

Advance LP (Low Profile)

Plain Old Balloon Angioplasty (POBA)

Intervention Type DEVICE

Paclitaxel (PTX)

Intervention Type DRUG

Eligibility Criteria

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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