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

Launched by SINGAPORE GENERAL HOSPITAL · Aug 11, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness of a special drug-coated balloon compared to a regular balloon in treating problems with arteriovenous fistulas (AVFs). AVFs are created for patients who need dialysis, and sometimes they can develop narrow areas (stenosis) that make it difficult for blood to flow properly. The trial aims to see which treatment helps keep the AVF open longer, allowing for better dialysis access.

To participate in this study, you need to be at least 21 years old and have an AVF that has been working for at least a month but has developed at least one narrow spot that is causing issues. You should also be able to give informed consent, meaning you understand the trial and agree to take part. However, certain conditions might exclude you from joining, like having a blocked AVF or certain allergies. If you decide to participate, you will receive either the drug-coated balloon or the regular balloon treatment and will help researchers learn which option is better for keeping AVFs functioning well.

Gender

ALL

Eligibility criteria

• 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.