NCT05173857

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

Completed NA Last updated 14 January 2022

What this trial tests

NA trial testing Advance PTX in Vascular Diseases in 42 participants. Completed in 31 July 2018.

Timeline

1 March 2014

Primary endpoint
31 July 2017

31 July 2018

Quick facts

Lead sponsor	Skane University Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	42
Start date	1 March 2014
Primary completion	31 July 2017
Estimated completion	31 July 2018

Drugs / interventions tested

• Advance PTX
• Advance LP (Low Profile)
• Paclitaxel (PTX) — full drug profile →

Conditions studied

• Vascular Diseases — all drugs for Vascular Diseases →
• Kidney Diseases — all drugs for Kidney Diseases →

Sponsor

Skane University Hospital

Who can join

18 and older, any sex, with Vascular Diseases or Kidney Diseases. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Drug-eluting balloon (DEB) versus plain old balloon angioplasty (POBA) in the treatment of failing dialysis access: A prospective randomized trial.
   Fransson T, Gottsäter A, Abdulrasak M, Malina M, et al · · 2022 · cited 8× · PMID 35354342 · DOI 10.1177/03000605221081662