Drug Eluting Balloon Venoplasty in AV Fistula Stenosis

Study Overview
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Brief Summary
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DeVA is a single blinded, prospective, multicentre RCT designed to determine the safety and effectiveness of a drug eluting angioplasty balloon compared with a standard angioplasty balloon in patients with symptomatic native AV fistula stenosis.

Official Title
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Improving Outcomes in Fistula Intervention: A Prospective, Patient Blinded, Phase 3, Randomised Controlled Trial of Drug Eluting Balloons in the Angioplasty of Native Haemodialysis Access Arteriovenous Fistula Outflow Stenosis (DeVA)

Conditions
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Native Arteriovenous Fistula, Stenosis

Intervention / Treatment
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* Device: Drug eluting balloons
* Device: Non drug eluting balloons


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Arteriovenous (AV) fistulas with stenosis requiring percutaneous angioplasty identified on routine diagnostic imaging or causing clinical concern on dialysis. Fistula has been in use for at least 1 month and is > 6 weeks old Brachiocephalic AV fistula Brachiobasilic AV fistula Radiocephalic AV fistula (both proximal and distal) Participant >/=18 yrs old Index lesion is less then the length of the DEB, and the reference vessel diameter is appropriate for treatment with the size range of DEB (4mm - 8mm diameter) Participant is able to give valid informed consent Exclusion Criteria: Allergy to iodinated Intravenous contrast Allergy to Paclitaxel Prosthetic grafts Long or tandem lesions that cannot be treated with a single DEB Thrombosed Arterio-Venous fistulas Women who are breastfeeding, pregnant or intending to become pregnant Participants of child-bearing age who are unwilling to use a reliable form of contraception for the duration of the study.

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 |
| --- | --- |
| Experimental: Experimental<br>Drug eluting angioplasty balloons | Device: Drug eluting balloons<br> <br> |
| Active Comparator: Control<br>Non-drug eluting balloons | Device: Non drug eluting balloons<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patency | Primary end point is a composite of one or more of : >50% stenosis of index lesion requiring re-intervention Re-intervention of index lesion due to clinical indications without 50% re-stenosis Fistula failure | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical success | Defined as <30% residual stenosis using only the study balloon to which the patient was randomised | Time of baseline index intervention | 
| Assisted technical success of balloon angioplasty | Defined as <30% residual stenosis using adjunctive procedures in addition to study balloon | At time of baseline index intervention | 
| Successful use of fistula for dialysis | Defined as successful use of the fistula for dialysis using 2 needles on at least one occasion | In the 12 months following baseline index intervention | 
| Secondary patency of the access circuit |  | In the 12 months following baseline index intervention |