Angioplasty of all peripheral AVF stenosis: All peripheral AVF stenosis are to be treated with the same type of balloon depending on allocation
Study 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
Eligibility
Sex
ALL
Min age
21 Years
Max age
—
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.
Primary outcome measure(s)
Access circuit primary patency — 6 months Time to next clinically-driven intervention
Trial sites (1)
Facility
City
Region
Status
Singapore General Hospital
Singapore
Singapore
Recruiting
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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