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

Kings College London0 sites212 target enrollmentOctober 28, 2015

Overview

Registry

who.int

Start Date

October 28, 2015

End Date

October 4, 2019

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

Kings College London

•1\. Patients (18 years or over) who have a native AVF in the arm that has been used for at least 12 consecutive dialysis sessions
•2\. An indication for a fistuloplasty as determined by the local clinical team
•3\. The access circuit is free of synthetic graft material or stents
•4\. A reduction of vessel diameter of greater than or equal to 50%, and a reference diameter of the outflow vein of at least 4 mm and less that the diameter of the largest available paclitaxel\-coated balloon
•5\. A residual stenosis of 30% after plain balloon fistuloplasty

•1\. Patient unable to give informed consent
•2\. Patient unwilling or unable to comply with all studyrelated procedures
•3\. Systemic or local (to the fistula) infection treated for less than 10 days prior to the study procedure
•4\. Synchronous venous lesion, with a reduction of vessel diameter of greater than or equal to 50% measured angiographically, in the same access circuit
•5\. Location of stenosis beyond the thoracic inlet
•6\. Thrombosed (failed) dialysis circuit at time of treatment
•7\. Women who are breastfeeding, pregnant or are intending to become pregnant or men intending to father children, within 2 years of study treatment
•8\. Known hypersensitivity or contraindication to contrast medium which cannot be adequately pre\-medicated
•9\. Known hypersensitivity or contraindication to paclitaxel