Paclitaxel assisted balloon angioplasty of venous stenosis in haemodialysis access: PAVE trial

Not Applicable

Completed

• Conditions: Topic: Renal disorders; Subtopic: Renal disorders; Disease: All Renal disorders; Circulatory System; Arteriovenous fistula (AVF)

• Registration Number: ISRCTN14284759
• Lead Sponsor: Kings College London

Brief Summary

2016 Protocol article in http://www.ncbi.nlm.nih.gov/pubmed/27175481 protocol 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/33781793/ (added 03/08/2021) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34582135/ (added 08/11/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-10-28
• Study Completion: 2019-10-04
• Last Update Posted: 20 November 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 212

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified