Renal failure Urological and Genital Diseases Renal failure
Conditions
Interventions
Participants are randomised into one of two arms.
Intervention arm: Participants receive a fistuloplasty procedure using a paclitaxel-coated balloon.
Control arm: Part
Sponsors
University Hospital Birmingham NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Arteriovenous (AV) fistulas with stenosis requiring percutaneous angioplasty identified on routine diagnostic imaging or causing clinical concern on dialysis 2. Fistula has been in use for at least 1 month and is more than 6 weeks old 3. Brachiocephalic AV fistula 4. Brachiobasilic AV fistula 5. Radiocephalic AV fistula (both proximal and distal) 6. Aged 18 years or over 7. Index lesion is less then the length of the DEB, and the reference vessel diameter is appropriate for treatment with the size range of DEB (4mm 8mm diameter) 8. Capacity to give valid informed consent
Exclusion criteria
Exclusion criteria: 1. Allergy to iodinated Intravenous contrast 2. Allergy to Paclitaxel 3. Prosthetic grafts 4. Long or tandem lesions that cannot be treated with a single DEB 5. Thrombosed ArterioVenous fistulas 6. Women who are breastfeeding, pregnant or intending to become pregnant 7. Participants of childbearing age who are unwilling to use a reliable form of contraception for the duration of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Presence of at least 50% restenosis of index lesion requiring re-intervention is measured at 3, 6 and 12 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Fistula failure rate (thrombosis or non-salvageable) is measured at 3, 6 and 12 months 2. Re-intervention rate due to clinical or paraclinical indictions (without 50% restenosis) is measured at 3, 6 and 12 months | — |
Countries
England, United Kingdom
Outcome results
None listed