DEB-after-Cutting Balloon-PTA in Dialysis Fistula Stenosis

Study Overview
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Brief Summary
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The incidence of hemodynamically relevant dialysis fistula stenoses/obstructions after 1 year is between 60-90% (from 62.5 to 91% radiocephalic, brachiocephalic 70-84%, PTFE shunts 62-87%), necessitating a therapeutic measure to preserve dialysis access during this period in 1/3 of the patients. This therapeutic measure is a dilatation of the stenosis using a standard PTA balloon (POBA, plain old balloon angioplasty with a primary technical success rate of 50-79% [2-4].In turn, in 21-50% of the cases an insufficient PTA result is obtained (so-called POBA-resistant stenosis). In these cases, predilatation with a so-called cutting balloon (carrying with small knives on its surface) is performed, leading to a success rate of 89%. However, a problem is the high incidence of restenosis, which is about 40% for recurrent stenosis and over 10% in de novo stenosis. The use of drug-coated balloon (DCB) in non-POBA resistant stenoses lead to a reduction in the restenosis rate of 35% to 5%. However, the effect of DCB in POBA resistant stenoses is unknown. Therefore, the aim of this study is to evaluate the clinical benefit of the combined use of a cutting balloon and a drug-coated balloon in POBA resistant dialysis fistula stenoses compared to the sole use of a cutting balloon.

Official Title
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Prospective, Randomized Trial on the Clinical Utility of Drug-coated Balloons After Angioplasty of Plain Old Balloon-resistent Dialysis Fistula Stenosis Using Cutting Ballons

Conditions
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Renal Insufficiency

Intervention / Treatment
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* Device: Angioplasty with drug-coated balloon
* Device: Angioplasty with plain old balloon


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: dialysis fistula dysfunction requiring cutting balloon angioplasty Exclusion Criteria: missing informed consent or unable to consent age < 18 years pregnancy

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 |
| --- | --- |
| Placebo Comparator: POBA-after-Cutting Balloon<br>After cutting balloon angioplasty, subsequent angioplasty is performed using a standard, non-coated balloon (plain old balloon, POBA). | Device: Angioplasty with plain old balloon<br>* Angioplasty with plain old balloon Sterling (BostonScientific, Switzerland)<br>* Other names: balloon Sterling;|
| Active Comparator: DCB-after-Cutting Balloon<br>After cutting balloon angioplasty, subsequent angioplasty is performed using a drug-coated balloon (DCB) | Device: Angioplasty with drug-coated balloon<br>* Angioplasty with drug-coated balloon Elutax (Aachen Resonance, Germany)<br>* Other names: drug-coated balloon Elutax;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to worsening of dialysis fistula function [days] |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in lumen 12 months after PTA [mm] | aka late lumen loss | one year | 
| Change in dialysis flow [ml/min.] |  | one year | 
| Change in dialysis fistula flow [ml/min.] |  | one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dialysis