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

Sponsor

Skane University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT05173857

Collaborator

(none)

Enrollment

Arms

Actual Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Vascular Diseases Kidney Diseases	Device: Advance PTX Device: Advance LP (Low Profile) Drug: Paclitaxel (PTX)	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

42 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

Drug Eluting Balloon (DEB) vs Plain Old Balloon Angioplasty (POBA) for the Treatment of Failing Dialysis Access. A Prospective Randomized Trial

Actual Study Start Date :

Mar 1, 2014

Actual Primary Completion Date :

Jul 31, 2017

Actual Study Completion Date :

Jul 31, 2018

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Drug Eluting Balloon (DEB) Percutaneous Angioplasty in dysfunctional arteriovenous access, using Drug Eluting Balloon Technology. Drug: Paclitaxel (PTX). Name of Device: Advance PTX	Device: Advance PTX PTA in Dysfunctional Haemodialysis Access Drug: Paclitaxel (PTX) Paclitaxel (PTX)
Placebo Comparator: 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)	Device: Advance LP (Low Profile) Plain Old Balloon Angioplasty (POBA)

Arm

Intervention/Treatment

Active Comparator: Drug Eluting Balloon (DEB)

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

Device: Advance PTX

PTA in Dysfunctional Haemodialysis Access

Drug: Paclitaxel (PTX)

Paclitaxel (PTX)

Placebo Comparator: 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)

Device: Advance LP (Low Profile)

Plain Old Balloon Angioplasty (POBA)

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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