Drug Eluting Balloon Venoplasty in AV Fistula Stenosis

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)

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.

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.