(Paclitaxel assisted balloon Angioplasty of Venous Stenosis in haEmodialysis access)
The PAVE Trial is a randomised controlled trial (people taking part are put into one or other group at random – see below). It aims to preserve arteriovenous fistulae (AVF), used for haemodialysis. We plan to start recruiting haemodialysis patients in October 2015.
Vascular access for haemodialysis
Haemodialysis requires access to the circulation (blood stream) and the best option for this is an AVF, which is made by surgically joining an artery and a vein. However, these AVFs have a limited life and may develop narrowed segments. This can lead to thrombosis (blockage), which may result in admission to hospital and the insertion of temporary dialysis lines which are prone to infection. The standard treatment for the narrowed segments is to use a special balloon to stretch the segment. This is done in the X-ray department. Unfortunately, the narrowing can return.
The aim of the PAVE trial is to test whether using a drug-coated balloon can delay the return of the narrowing and keep the AVF in use for longer.
The trial is funded through the National Institute for Health Research (NIHR), with the balloons provided by a company called Bard. King’s College London together with Guy’s and St Thomas’ NHS Foundation Trust co-ordinate the trial.
If you take part in the trial you will be randomly placed into one of two groups. Immediately after treatment with the standard balloon that is normally used, one group will receive another treatment with the drug-coated balloon and the other group will receive another treatment with a balloon which is not drug-coated. You will then be followed up for at least one year.
The two groups can then be compared to see if the AVFs of people in one group last longer than those in the other group. The trial will gather evidence of the safety and potential benefit of using the drug-coated balloon. The outcome of the trial will be evidence to identify the best method to use, so that we can safely improve patients’ quality of life on dialysis.
We will recruit 211 haemodialysis patients, from six kidney units across the UK. The chief investigator is Dr Michael Robson, the lead surgeon is Mr Francis Calder, and the lead radiologist is Dr Narayan Karunanithy. These three doctors are all based at Guy’s hospital. There is a safety committee of experts who will check the data and ensure that no patient is placed at risk.
For more information about the PAVE trial, please contact Vikki Semik, the PAVE Clinical Trial Manager, at firstname.lastname@example.org.