Randomised Clinical Trial Comparing Drug-coated Balloon to Plain Balloon for All Peripheral AVF Stenosis
Recruiting now · Phase 3
Conditions studied: Arteriovenous Fistula, Arteriovenous Fistula Stenosis, Dialysis Access Malfunction
In brief
To compare the access circuit primary patency after Ranger drug-coated balloon angioplasty of arteriovenous fistula (AVF) stenosis with that after conventional balloon angioplasty
Key facts
- Study ID
- NCT06553443
- Run by
- Singapore General Hospital
- People needed
- 94
- Starts
- 2024-01-04
- Expected to finish
- 2029-12-31
- Last updated by the study team
- 2024-08-14
Who can join
Age: 21 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Failing AVF with at least 1 AVF stenosis presenting with any clinical, physiological or haemodynamic abnormalities. Both de novo and recurrent stenosis are accepted.
- AVF has been used successfully for at least 1 month (non-mature AVF are not allowed).
- Less than 30% residual stenosis after angioplasty.
- ≥ 21 years old
- Informed and valid consent given.
You may not qualify if…
- Thrombosed AVFs
- Haemodynamically significant central vein stenosis
- Target lesion not treatable with the available sizes of drug eluting balloon (up to 8mm)
- Contraindication to antiplatelet therapy
- Coagulopathy or thrombocytopenia that cannot be managed adequately with periprocedural transfusion.
- Allergy / contraindication to paclitaxel.
- Acute infection over proposed puncture site.
- Women who are breastfeeding, pregnant * or planning on becoming pregnant during study.
- Participant with medical conditions, which in the opinion of the investigator may cause noncompliance with protocol.
- 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.
Where it is running
- Singapore General Hospital — Singapore, Singapore (enrolling)
Full record on ClinicalTrials.gov
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