Comparing drug-coated balloons to plain balloons for treating AVF stenosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the effectiveness of Ranger drug-coated balloon angioplasty compared to conventional balloon angioplasty in patients with arteriovenous fistula (AVF) stenosis. It is a blinded randomized controlled trial involving 94 participants who will be assigned in a 1:1 ratio to receive either treatment. The primary outcome measure is the access circuit patency after six months, assessing how well each method maintains the function of the AVF. The study seeks to provide insights into improving dialysis access outcomes for patients with AVF stenosis.

Why it matters

Who can join: the full rules

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.

Where it's running

• Singapore General Hospital
  Singapore, Singapore Recruiting

Study contacts

• Study coordinator: Arjunana Sarupraba
• Email: arjunana.sarupraba@sgh.com.sg
• Phone: 6222 3322

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.