Table 1 Inclusion and exclusion criteria for the trial
Inclusion criteria | Exclusion criteria |
|---|---|
1. Patients (18 years or over) who have a native AVF in the arm | 1. Patient unable to give informed consent |
2. An indication for a fistuloplasty as determined by the local clinical team | 2. Patient unwilling or unable to comply with all study-related procedures |
3. The access circuit is free of synthetic graft material or stents | 3. Systemic or local (to the fistula) infection treated for less than 10 days prior to the study procedure |
4. A reduction of vessel diameter ≥50 % measured angiographically and reference diameter of the outflow vein ≥4 mm and less than the size of the largest available DCB | 4. Synchronous venous lesion, with a reduction of vessel diameter of ≥50 % measured angiographically, in the same access circuit |
5. A residual stenosis ≤30 % after plain balloon fistuloplasty | 5. Location of stenosis central to the thoracic inlet |
6. Thrombosed (failed) access 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 premedicated | |
9. Known hypersensitivity or contraindication to paclitaxel |