Topic: Renal disorders
Conditions
Interventions
Participants are randomised into one of two arms.
Intervention arm: Participants will receive standard-of-care fistuloplasty with a plain balloon, followed directly by insertion of a
follow-up will end when the last recruited participant has been followed for 1 year.
Sponsors
Kings College London
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to end of target lesion primary patency* is determined through AVF imaging when patient is referred for a re-intervention, at any point during follow-up (1-3 years). *Primary patency fails when any of the following occur: 1. Clinically driven re-intervention to the treatment segment 2. Thrombotic occlusion that includes the treatment segment 3. Surgical intervention that excludes the treatment segment from the access circuit 4. Abandonment of the AVF due to an inability to retreat the treatment segment | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Angiographically determined late lumen loss; measured on a protocol fistulogram at 6 months by an independent core laboratory 2. The rate of angiographic binary re-stenosis; measured on a protocol fistulogram at 6 months by an independent core laboratory 3. Time to end of access circuit primary patency* measured at a referred re-intervention, at any point during follow-up (1-3 years) 4. Time to end of access circuit cumulative patency (when the AVF is abandoned, regardless of radiological or surgical intervention, with or without a thrombosis event) measured at a referred re-intervention, at any point during follow-up (1-3 years) 5. Procedural success determined by measuring residual stenosis (= 30%) on post-procedure fistulogram, after treatment fistuloplasty 6. Number of thrombosis events measured at end of follow-up (1-3 years) 7. Total number of interventions measured at end of follow-up (1-3 years) 8. Adverse events (e.g. fistula rupture, infection) measured at end of follow-up (1-3 years) 9. Patient quality of life measured using the EuroQuol EQ-5D generic health survey, and the disease specific Patient (or Palliative care) Outcome Scale symptom score-renal (POS-S Renal) at baseline, 6, and 12 months *Ends when any of the following occur: 1. Access circuit thrombosis 2. An intervention (either radiological or surgical) anywhere in the access circuit 3. The access circuit is abandoned due to an inability to treat any lesion | — |
Countries
England, United Kingdom
Contacts
Public ContactLeanne Gardner
Outcome results
None listed