Clinical Trial

Post Approval Study Investigating Lutonix Drug Coated Balloon for Treatment of Dysfunctional Arteriovenous Fistulae

Study acronym: AVPAS
Active, Not Recruiting
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Summary
This prospective, global, multicenter, single arm post-approval study is designed to investigate the clinical use and safety of the Lutonix® 035 AV Drug Coated Balloon (DCB) PTA Catheter in subjects presenting with clinical and hemodynamic abnormalities in native arteriovenous (AV) fistulae located in the upper extremity.
Protocol Amendment History 18 amendments
This ClinicalTrials.gov record has been amended 18 times since 2018-04-14; most recent amendment 2026-03-16.
Status change: Recruiting → Active, Not Recruiting 2026-03-16
Status change: Not Yet Recruiting → Recruiting 2018-07-30
Trial Details
NCT Number NCT03506308
Lead Sponsor C. R. Bard
Conditions Arteriovenous Fistula
Enrollment 213 participants
Start Date 2018-08-07
Primary Completion 2027-04 (estimated)
Study Completion 2030-04 (estimated)
Updated on ClinicalTrials.gov 2026-03-18