RecruitingPhase 3

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

Singapore94 participantsStarted 2024-01-04

Plain-language 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

Who can participate

Age range21 Years

SexALL

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Inclusion criteria

✓. 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 criteria

✕. 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.

What they're measuring

Access circuit primary patency

Timeframe: 6 months

Trial details

NCT IDNCT06553443

SponsorSingapore General Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12-31

Contact for this trial

Arjunana Sarupraba

6222 3322 arjunana.sarupraba@sgh.com.sg

View on ClinicalTrials.gov More Arteriovenous Fistula trials