PAVE trial v1.0
Research type
Research Study
Full title
Paclitaxel assisted balloon Angioplasty of Venous stenosis in haEmodialysis access: The PAVE Trial. A multicentre double-blind randomised controlled trial in haemodialysis patients with a stenosis in a native arteriovenous fistula.
IRAS ID
176799
Contact name
Michael Robson
Contact email
Sponsor organisation
King's College London
Duration of Study in the UK
3 years, 11 months, 30 days
Research summary
When kidney function is not sufficient to sustain life, dialysis or transplantation is required. For haemodialysis, access to the circulation is required. The best method is via an arteriovenous fistula (AVF), made by surgically joining an artery and a vein. The fistulae commonly develop narrowed segments which can lead to thrombosis (blockage), and often a need for hospital admission and insertion of temporary dialysis lines. These temporary lines are prone to infection. The narrowed segments are treated in the xray department with a special balloon which is inflated to stretch the narrowed segment. However, the narrowing can return and around 60% of patients need a repeat procedure during the first year. There is evidence that in narrowed arteries in the legs and heart, using a balloon coated with certain drugs can inhibit the biological processes that cause narrowing after balloon treatment. In this project we plan to employ drug-coated balloons in AVF used for haemodialysis. The research will include haemodialysis patients with a narrowed fistula from several NHS hospitals. Patients will receive the drug-coated balloon treatment after a narrowed fistula has been dilated with a normal balloon. We will compare the outcomes in patients that were treated with the paclitaxel-coated balloon and the control group who were treated with an uncoated balloon. The main assessment of outcome will be the time taken for the narrowing to recur, preventing the fistula from being used or necessitating another procedure. We will collect blood samples for future mechanistic studies that may help to develop tests that predict the response to treatment and suggest the best therapeutic option for a specific patient. We anticipate that we will recruit participants for 2 years and the study will finish when the last patient has completed at least 1 year of follow-up.
REC name
London - Chelsea Research Ethics Committee
REC reference
15/LO/0638
Date of REC Opinion
12 May 2015
REC opinion
Further Information Favourable Opinion