Randomised Clinical Trial Comparing Drug-coated Balloon to Plain Balloon for All Peripheral AVF Stenosis

This is a blinded randomized controlled trial recruiting 94 patients with AVF stenosis who will be randomized in a 1:1 ratio to either drug-coated balloon (Ranger) or conventional balloon. All peripheral AVF stenoses will be treated with the allocated balloon type.

The primary outcome measure is 6-month access circuit patency.

Inclusion criteria

• Failing AVF with at least 1 AVF stenosis presenting with any clinical, physiological or haemodynamic abnormalities. Both de novo and recurrent stenosis are accepted.
• AVF has been used successfully for at least 1 month (non-mature AVF are not allowed).
• Less than 30% residual stenosis after angioplasty.
• ≥ 21 years old
• Informed and valid consent given.

Exclusion criteria

• Thrombosed AVFs
• Haemodynamically significant central vein stenosis
• Target lesion not treatable with the available sizes of drug eluting balloon (up to 8mm)
• Contraindication to antiplatelet therapy
• Coagulopathy or thrombocytopenia that cannot be managed adequately with periprocedural transfusion.
• Allergy / contraindication to paclitaxel.
• Acute infection over proposed puncture site.
• Women who are breastfeeding, pregnant * or planning on becoming pregnant during study.
• Participant with medical conditions, which in the opinion of the investigator may cause noncompliance with protocol.
• Currently participating in an investigational drug, biologic or device trial that may have an impact on the dialysis access or previous enrolment in this study.