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

Not Applicable

Completed

• Conditions: Vascular Diseases; Kidney Diseases
• Interventions: Device: Advance PTX; Device: Advance LP (Low Profile); Drug: Paclitaxel (PTX)

• Registration Number: NCT05173857
• Lead Sponsor: Skane University Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-03-01
• Primary Completion: 2017-07-31
• Study Completion: 2018-07-31
• Study First Submitted: 2021-11-10
• Status Verified: 2021-12
• Study First Submitted QC: 2021-12-29
• Last Update Submitted: 2021-12-29
• Study First Posted: 2021-12-30
• Last Update Posted: 2022-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Drug Eluting Balloon (DEB)	Advance PTX	Percutaneous Angioplasty in dysfunctional arteriovenous access, using Drug Eluting Balloon Technology. Drug: Paclitaxel (PTX). Name of Device: Advance PTX
Drug Eluting Balloon (DEB)	Paclitaxel (PTX)	Percutaneous Angioplasty in dysfunctional arteriovenous access, using Drug Eluting Balloon Technology. Drug: Paclitaxel (PTX). Name of Device: Advance PTX
Plain Old Balloon Angioplasty (POBA)	Advance LP (Low Profile)	Percutaneous Angioplasty in dysfunctional arteriovenous access, using Plain Old Balloon Angioplasty. Drug: None. Name of Device: Advance LP (Low Profile)

Primary Outcome Measures

Name	Time	Method
Stenosis or occlusion in treated vascular access	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)
Freedom from restenosis in treated vascular access	12 months	Freedom from Restenosis and Target Lesion Revascularization (TLR) during 12 months follow up
Number of Participants with a vascular access in full clinical use for haemodialysis at 12 months	12 months	Functional status of vascular access.