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

Study Overview
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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.

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

Conditions
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Vascular Diseases, Kidney Diseases

Intervention / Treatment
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* Device: Advance PTX
* Device: Advance LP (Low Profile)
* Drug: Paclitaxel (PTX)


Participation Criteria
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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 Exclusion Criteria: Thrombosed access In stent restenosis Pregnancy Age less than 18 years

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Drug Eluting Balloon (DEB)<br>Percutaneous Angioplasty in dysfunctional arteriovenous access, using Drug Eluting Balloon Technology. Drug: Paclitaxel (PTX). Name of Device: Advance PTX | Device: Advance PTX<br>* PTA in Dysfunctional Haemodialysis Access<br>Drug: Paclitaxel (PTX)<br>* Paclitaxel (PTX)<br>|
| Placebo Comparator: Plain Old Balloon Angioplasty (POBA)<br>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)<br>* Plain Old Balloon Angioplasty (POBA)<br>|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Drug-eluting balloon, Angioplasty, Haemodialysis, Fistula, Stenosis, Paclitaxel