PAVE-2
Research type
Research Study
Full title
Paclitaxel or sirolimus coated balloons used for ArterioVEnous fistulas - 2 (PAVE-2 trial) A double-blind randomised controlled clinical trial to determine the efficacy of paclitaxel or sirolimus coated balloons in arteriovenous fistulas for haemodialysis
IRAS ID
323715
Contact name
Michael Robson
Contact email
Sponsor organisation
King's College London
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
4 years, 11 months, 30 days
Research summary
In order to perform haemodialysis, access to blood vessels is needed. The best way of doing this is by making what is called an ‘arteriovenous fistula’. This is when a surgeon joins an artery and a vein together. The fistula can have needles inserted into it so that blood can go to and from the dialysis machine. Fistulas have a limited life and may become narrow in places. This can lead to a blood clot (which is called a thrombosis). When this happens, the patient may need to come into hospital so that a temporary dialysis line can be inserted into a large vein in the neck or groin. The narrowing is usually treated by inflating a balloon specifically designed to be used inside blood vessels, called an angioplasty balloon. In about half of the cases the narrowing can happen again during the next year so the balloon treatment has to be repeated. Balloons have been used to apply drugs to the inside of the arteriovenous fistula as this will cause fewer side effects than if the drugs were taken as tablets or via an injection. This project is going to compare outcomes of patients in three large groups and plan to include 642 people from at least 20 UK hospitals. Patients who agree to take part will be allocated by chance into one of the three groups. Fistulas will be treated with (1) paclitaxel-coated balloons (2) sirolimus coated balloons or (3) uncoated balloons. We will compare the outcomes for each of the two groups treated with paclitaxel or sirolimus coated balloons with the control group who were treated with uncoated balloons. We will follow up for 1 year and see how long it takes for the fistula to block or for the patient to need another balloon treatment.
REC name
London - Hampstead Research Ethics Committee
REC reference
23/LO/0625
Date of REC Opinion
17 Jul 2023
REC opinion
Favourable Opinion