This is a multicentre double-blind randomised controlled clinical trial aiming to determine the efficacy of additional paclitaxel-coated or sirolimus-coated balloons on outcomes after a plain balloon fistuloplasty to preserve the patency of arteriovenous fistulae used for haemodialysis.
Patients receiving treatment with haemodialysis will be recruited from renal units throughout the UK and at least 20 sites are expected to participate. Please see protocol for full inclusion and exclusion criteria. Following a successful plain balloon fistuloplasty, participants will be randomised to further treatment with a paclitaxel-coated balloon, a sirolimus-coated balloon, or an uncoated control balloon. We will recruit 642 patients over a three-year period. Patients will remain in the trial and be followed up for one year. Participants will be asked to consent for data collection from the clinical records for a further 2 years.
The primary endpoint is time to end of target lesion primary patency. Secondary endpoints are time to end of access circuit primary patency, time to AVF abandonment, procedural success, number of thrombosis events, adverse events, intima-media thickness, stenosis at 3 months on ultrasound and patient quality of life assessed by EQ-5D/ POS-S Renal.