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Clinical Trials in Singapore / NCT06553443
Recruiting Phase 3

Randomised Clinical Trial Comparing Drug-coated Balloon to Plain Balloon for All Peripheral AVF Stenosis

NCT06553443 · tracked via the Priya Life Science Singapore tracker
Phase
Phase 3
Started
2024-01-04
Last updated
2024-08-14

Condition(s) studied

Arteriovenous FistulaArteriovenous Fistula StenosisDialysis Access Malfunction

Investigational drug(s) / intervention(s)

Angioplasty of all peripheral AVF stenosis

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)

Trial sites (1)

FacilityCityRegionStatus
Singapore General Hospital Singapore Singapore Recruiting

More Singapore General Hospital trials in Singapore

Official registry record

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.

View NCT06553443 on ClinicalTrials.gov ↗ ← All trials in Singapore