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

Skane University Hospital

Status: Completed

Conditions: Kidney Diseases; Vascular Diseases

Treatments: Device: Advance PTX; Device: Advance LP (Low Profile); Drug: Paclitaxel (PTX)

Study type: Interventional

Funder types: Other

Identifiers

NCT05173857

TF1

Details and patient eligibility

About

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.

Enrollment: 42 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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42 participants in 2 patient groups, including a placebo group

Drug Eluting Balloon (DEB)

Active Comparator group

Description:

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

Treatment:

Device: Advance PTX

Drug: Paclitaxel (PTX)

Plain Old Balloon Angioplasty (POBA)

Placebo Comparator group

Description:

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

Treatment:

Device: Advance LP (Low Profile)