Comparing drug-coated balloons to plain balloons for treating AVF stenosis
Randomised Clinical Trial Comparing Drug-coated Balloon to Plain Balloon for All Peripheral AVF Stenosis
This study is testing if a special drug-coated balloon works better than a regular balloon for treating narrow spots in blood vessels for patients with arteriovenous fistula stenosis.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 94 (estimated) |
| Ages | 21 Years and up |
| Sex | All |
| Sponsor | Singapore General Hospital Academic / other |
| Locations | 1 site (Singapore) |
| Trial ID | NCT06553443 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 21 and older with failing AVFs that have at least one stenosis and have been used successfully for at least one month.
Not a fit: Patients with thrombosed AVFs or significant central vein stenosis will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved long-term patency rates for patients undergoing dialysis.
How similar studies have performed: Previous studies have shown promising results with drug-coated balloons in similar vascular interventions, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Singapore
- Singapore General Hospital — Singapore, Singapore (Recruiting)
Study contacts
- Study coordinator: Arjunana Sarupraba
- Email: arjunana.sarupraba@sgh.com.sg
- Phone: 6222 3322
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.