Status:
RECRUITING
Randomised Clinical Trial Comparing Drug-coated Balloon to Plain Balloon for All Peripheral AVF Stenosis
Lead Sponsor:
Singapore General Hospital
Collaborating Sponsors:
Singapore Clinical Research Institute
Boston Scientific Corporation
Conditions:
Arteriovenous Fistula
Arteriovenous Fistula Stenosis
Eligibility:
All Genders
21+ years
Phase:
PHASE3
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 periphe...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
January 4 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2029
Estimated Enrollment :
94 Patients enrolled
Trial Details
Trial ID
NCT06553443
Start Date
January 4 2024
End Date
December 31 2029
Last Update
August 14 2024
Active Locations (1)
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1
Singapore General Hospital
Singapore, Singapore