Arteriovenous fistulas for haemodialysis Urological and Genital Diseases
Conditions
Interventions
Current intervention as of 07/08/2023:
Following the clinically-indicated fistuloplasty, patients will be allocated by chance into one of the three groups. Fistulas will be treated with paclitaxel-coa
Sponsors
King's College London
Guy's and St Thomas' NHS Foundation Trust
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 14/05/2024: 1. Patients (18 years or over) who have a surgically formed AVF in the arm which has been used for at least 8 dialysis sessions in the preceding 4 weeks 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. Patient able to give informed consent 5. Patient willing and able to comply with all study-related procedures 6. People who are not breastfeeding, not pregnant, not intending to become pregnant or not intending to father children, within two years of study treatment 7. No evidence of active systemic or local (to the fistula) infection 8. No known hypersensitivity or contraindication to contrast medium which cannot be adequately premedicated 9. No known hypersensitivity or contraindication to paclitaxel or sirolimus 10. One or two treatment segments. Each treatment segment will contain one or more stenoses of at least 50% 11. Each treatment segment will be amenable to treatment with a single drug-coated balloon 8cm in length or two overlapping drug-coated balloons 4 cm in length Previous inclusion criteria: 1. Patients (18 years or over) who have an AVF in the arm which has been used for at least 8 dialysis sessions in the preceding 4 weeks 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. Patient able to give informed consent 5. Patient willing and able to comply with all study-related procedures 6. People who are not breastfeeding, not pregnant, not intending to become pregnant or not intending to father children, within two years of study treatment 7. No evidence of active systemic or local (to the fistula) infection 8. No known hypersensitivity or contraindication to contrast medium which cannot be adequately premedicated 9. No known hypersensitivity or contraindication to paclitaxel or sirolimus 10. One or two treatment segments. Each treatment segment will contain one or more stenoses of at least 50% 11. Each treatment segment will be amenable to treatment with a single drug-coated balloon 8cm in length or two overlapping drug-coated balloons 4 cm in length
Exclusion criteria
Exclusion criteria: 1. Thrombosed (failed) access circuit at time of treatment 2. Location of a stenosis central to the thoracic inlet 3. The presence of a lesion that has been treated with a plain balloon fistuloplasty where the diameter of the outflow vein is larger than the size of the largest available drug-coated balloon 4. The presence of a lesion that has been treated with a plain balloon fistuloplasty where the diameter of the outflow vein is considered too small to be treated with the smallest available drug-coated balloon 5. A significant residual stenosis (more than 30%) at any treated lesion after plain balloon fistuloplasty 6. Lack of availability of any of the three types of treatment balloon (Medtronic IN.PACT, Concept Medical MagicTouch or control) at the required size
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to end of treatment segment primary patency (TSPP). TSPP ends when any of the following occurs: (a) clinically driven re-intervention to the treatment segment; (b) thrombotic occlusion considered to be due to restenosis at the treatment segment; (c) surgical intervention that excludes the treatment segment from the access circuit; (d) abandonment of the AVF due to an inability to retreat the treatment segment. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Time to loss of primary patency at any treatment segment 2. Time to end of access circuit primary patency. Access circuit primary patency ends when any of the following occurs: (a) access circuit thrombosis, (b) an intervention (either radiological or surgical) anywhere in the access circuit, or (c) the AVF is abandoned due to an inability to treat any lesion. 3. Time to AVF abandonment. AVF abandonment occurs when the AVF is abandoned, regardless of radiological or surgical intervention, with or without a thrombosis event. Multiple/repetitive treatments for stenoses that restore patency are compatible with cumulative patency. 4. Number of radiological or surgical interventions 5. Adverse events (e.g. thrombosis, infection localised to AVF, rupture of AVF) 6. Intima-media thickness and degree of stenosis measured using ultrasound at 3 months 7. Patient quality of life assessed by EQ-5D-5L and VASQoL at 6 and 12 months | — |
Countries
England, Scotland, United Kingdom, Wales
Outcome results
None listed