Arteriovenous Fistula, Arteriovenous Fistula Stenosis, Dialysis Access Malfunction
Conditions
Keywords
drug-coated balloon, access circuit patency
Brief summary
To compare the access circuit primary patency after Ranger drug-coated balloon angioplasty of arteriovenous fistula (AVF) stenosis with that after conventional balloon angioplasty
Detailed description
This is a blinded randomized controlled trial recruiting 94 patients with AVF stenosis who will be randomized in a 1:1 ratio to either drug-coated balloon (Ranger) or conventional balloon. All peripheral AVF stenoses will be treated with the allocated balloon type. The primary outcome measure is 6-month access circuit patency.
Interventions
DEVICEAngioplasty of all peripheral AVF stenosis
All peripheral AVF stenosis are to be treated with the same type of balloon depending on allocation
Sponsors
Singapore Clinical Research Institute
Boston Scientific Corporation
Singapore General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
All are blinded except procedurist and protocol administrator.
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Failing AVF with at least 1 AVF stenosis presenting with any clinical, physiological or haemodynamic abnormalities. Both de novo and recurrent stenosis are accepted. 2. AVF has been used successfully for at least 1 month (non-mature AVF are not allowed). 3. Less than 30% residual stenosis after angioplasty. 4. ≥ 21 years old 5. Informed and valid consent given.
Exclusion criteria
1. Thrombosed AVFs 2. Haemodynamically significant central vein stenosis 3. Target lesion not treatable with the available sizes of drug eluting balloon (up to 8mm) 4. Contraindication to antiplatelet therapy 5. Coagulopathy or thrombocytopenia that cannot be managed adequately with periprocedural transfusion. 6. Allergy / contraindication to paclitaxel. 7. Acute infection over proposed puncture site. 8. Women who are breastfeeding, pregnant \* or planning on becoming pregnant during study. 9. Participant with medical conditions, which in the opinion of the investigator may cause noncompliance with protocol. 10. Currently participating in an investigational drug, biologic or device trial that may have an impact on the dialysis access or previous enrolment in this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Access circuit primary patency | 6 months | Time to next clinically-driven intervention |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Access access circuit patency | 12 months | Time to next clinically-driven intervention |
| Access circuit assisted primary patency | 6 and 12 months | Time to next access thrombosis or surgical intervention. |
| Access circuit secondary patency | 6 and 12 months | Time to access abandonment or surgical revision / declotting |
| Procedural complication | 12 months | Complication related to procedure |
| Mortality | 12 months and 5 years | All cause mortality |
Countries
Singapore
Contacts
Primary ContactArjunana Sarupraba
Outcome results
None listed