Drug Eluting balloon Venoplasty in Arterio-venous fistula stenosis: v1
Research type
Research Study
Full title
Improving Outcomes in Fistula Intervention: A prospective, patient blinded, phase 3, randomised controlled trial of Drug Eluting Balloons in the Angioplasty of Native Haemodialysis Access Arteriovenous Fistula Outflow Stenosis (DeVA)
IRAS ID
183505
Contact name
Robert Jones
Contact email
Sponsor organisation
University Hospitals Birmingham NHS Foundation Trust
Duration of Study in the UK
3 years, 0 months, 0 days
Research summary
In order to dialyse a patient with renal failure, a connection can be made surgically between a vein and an artery, usually in the arm. These joined vessels, termed a fistula, become enlarged, allowing the placement of needles and hence an access point for haemodialysis lines. Unfortunately these fistulae can narrow in places (a stenosis) and this narrowing can cause poor flow and result in inadequate dialysis. The stenosis can also stop the fistula healing correctly (maturing) with an increased risk of blood clot formation (thrombosis) within the joined vessels. A healthy fistula is key to effective dialysis and if a fistula has less frequent episodes of narrowing it will function much better and ultimately improve patient overall life expectancy. Fistula stenosis can be treated by stretching the narrowing with a balloon which is introduced via the fistula through an incision in the skin and guided by xrays and ultrasound (angioplasty). However, the success of this intervention is limited by recurrence of the narrowing, which requires repeat intervention by angioplasty. Any intervention which could reduce the time to recurrence of vessel narrowing and show improved patency would lead to reduced costs, inconvenience and trauma to the patient. Drug Eluting Balloons (DEB's) are coated with a drug, such as Paclitaxel, which is delivered to the vessel wall when the balloon is inflated. This drug slows the growth of new smooth muscle cells in the vessel wall that may lead to re-narrowing. This study will compare the use of DEB's with standard balloons, which have no drug coating, during the angioplasty procedure to see If DEB's can be shown to reliably reduce the rate of re-stenosis.
REC name
East Midlands - Derby Research Ethics Committee
REC reference
15/EM/0483
Date of REC Opinion
19 Nov 2015
REC opinion
Favourable Opinion