Drug Coated Balloons vs Plain Balloons for the Management of Dysfunctional Dialysis Fistula

Study Overview
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Brief Summary
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Compare the effectiveness of drug-coated balloons to plain balloon angioplasty in reducing stenosis rates in dialysis arteriovenous fistulas (AVFs).

Detailed Description
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Objectives of the Study: Hypothesis: Drug-coated balloons improve functional and patency outcomes of failing/dysfunctional hemodialysis fistulas compared to plain uncoated balloons Aim of the Study: Compare the effectiveness of drug-coated balloons to plain balloon angioplasty in reducing stenosis rates in dialysis AVFs. Specific Objectives: Primary functional endpoint: Access circuit patency based on functional criteria at 12 month. Primary safety endpoint: Peri procedural complication rate Secondary endpoints: Technical success (<30% residual stenosis without postdilation) Access circuit dysfunction free survival (Time to event) based on functional criteria Target lesion restenosis free survival (Time to event) (in case of new lesion causes circuit dysfunction)

Official Title
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Drug Coated Balloons vs Plain Balloons for the Management of Dysfunctional Dialysis Fistula

Conditions
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Dysfunctional Dialysis Arteriovenous Fistula

Intervention / Treatment
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* Device: Vessel preparation with angioplasty
* Device: Plain balloon angioplasty
* Device: Drug coated balloon angioplasty


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Inclusion criteria >18 year old Dysfunctional dialysis fistula Radiocephalic Brachiocephalic Brachiobasilic Clinical criteria for diagnosis of dysfunctional fistula: Swelling of the fistula limb Prolonged bleeding after withdrawing access needles Abnormal pulsations or weak thrill. Functional criteria for the diagnosis of dysfunctional criteria: Arteriovenous fistula is unable to deliver dialysis blood flow (Qb) of equal to or more than 300 ml/min and/or access recirculation of more than 10% on at least two occasions, A rising trend of venous pressure or excessive negative arterial pressure, and/or unable to deliver a Kt/v of 1.2 or more. Non-thrombosed Exclusion Criteria: Dysfunctional arteriovenous (AV) grafts Thrombosed fistulas Intra-stent stenosis Stenoses not responding to balloon angioplasty and requiring stenting. Stenosis less than 50% Surgical intervention that excludes the treatment segment from the access circuit Systemic or local (to the fistula) infection treated for less than 10 days prior to the study procedure Location of isolated stenosis central to the thoracic inlet. Women who are breastfeeding, pregnant or are intending to become pregnant Known hypersensitivity or contraindication to contrast medium which cannot be adequately premeditated. Sensitivities to heparin, aspirin, other anticoagulant/antiplatelet therapies, and/or paclitaxel

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
Interventional Model Description: Open label randomized clinical trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Drug coated balloon angioplasty<br>Vessel preparation with Pre dilatation Vessel treatment with Drug-coated balloon | Device: Vessel preparation with angioplasty<br>* Vessel preparation with Pre dilatation: All lesions to be predilated with high pressure balloons until waist is obliterated. At least two minutes dilatation. Balloon sizing: not to exceed the average diameter of adjacent normal appearing non-aneurysmal segments by more than 25%. Multiple lesions: To be treated with single balloon if possible. To be treated with multiple inflation if cannot be covered with single balloon.<br>Device: Drug coated balloon angioplasty<br>* Lutonix® Drug Coated Balloon: The balloon is coated with a specialized formulation that includes the drug, paclitaxel. The paclitaxel coating is evenly distributed across the working length of the balloon at a surface concentration of 2 μg/mm2. The key functional characteristic of the formulation is to allow for release of paclitaxel to the tissue of the vascular wall during inflation. Inflation to nominal pressure for at least 1 minute. Balloon size: similar to the predilation balloon. New drug coated balloon will be required for each lesion.<br>|
| Active Comparator: Plain balloon angioplasty<br>Vessel preparation with Pre dilatation Vessel treatment with additional Plain balloon angioplasty: | Device: Vessel preparation with angioplasty<br>* Vessel preparation with Pre dilatation: All lesions to be predilated with high pressure balloons until waist is obliterated. At least two minutes dilatation. Balloon sizing: not to exceed the average diameter of adjacent normal appearing non-aneurysmal segments by more than 25%. Multiple lesions: To be treated with single balloon if possible. To be treated with multiple inflation if cannot be covered with single balloon.<br>Device: Plain balloon angioplasty<br>* Plain balloon angioplasty Vessel treatment with additional Plain balloon angioplasty: Inflation to nominal pressure for at least 1 minute. Balloon size: similar to predilation balloon.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AVF circuit patency | Dialysis adequacy to be assessed based on functional criteria | 12 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical success | <30% residual stenosis without postdilation | intra procedural | 
| Access circuit dysfunction free survival | Time to event based on functional criteria | 12 month | 
| Target lesion restenosis free survival | Time to event in case of new lesion causes circuit dysfunction | 12 month | 
| Number of participants with treatment-related adverse events | Number of participants with treatment-related adverse events as assessed by the Society of Interventional Radiology Clinical Practice Guidelines | 12 month following the procedure |