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

Study acronym: AVPAS
StatusActive, Not Recruiting
PhaseNot applicable
SponsorC. R. Bard
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Primary completion date: Sep 2025 to Apr 2027
    • Trial status: Recruiting to Active, Not Recruiting
    • Study completion date: Mar 2030 to Apr 2030
    • Site details revised at 26 of 26 sites
    v19
  2. Primary completion date: Mar 2025 to Sep 2025
    • Study completion date: Sep 2029 to Mar 2030
    v18
  3. Primary completion date: Dec 2023 to Mar 2025
    • Study completion date: Jun 2027 to Sep 2029
    v17
  4. Study sites: 18 to 26v16
  5. Primary completion date: Dec 2022 to Dec 2023
    • Study sites: 12 to 18
    • Study completion date: Dec 2023 to Jun 2027
    • Eligibility criteria shortened, about 35 words
    v15
Show 13 earlier versionsHide 13 earlier versions
  1. Primary completion date: Mar 2021 to Dec 2022v14 Show 4 more changesShow less
    • Study completion date: Sep 2022 to Dec 2023
    • Secondary endpoints revised (10)
    • Study description expanded, about 54 words
    • Site details revised at 10 of 12 sites
  2. Primary completion date: Mar 2020 to Mar 2021
    • Study completion date: Sep 2021 to Sep 2022
    v13
  3. Study sites: 11 to 12v12
  4. Site details revised at 2 of 11 sitesv11
  5. Study sites: 10 to 11v10
  6. Study sites: 8 to 10v9
  7. Study sites: 6 to 8v8
  8. Study sites: 5 to 6v7
  9. Study sites: 3 to 5v6
  10. Study sites: 2 to 3v5
  11. Start date changed from estimate of Sep 2018 to Aug 7, 2018v4
  12. Study sites: 1 to 2v3
  13. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
C. R. Bard
11 trials monitored
See 2 trials at risk
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.
Trial Details
NCT Number NCT03506308
Lead Sponsor C. R. Bard
Conditions
(from sponsor)		 Arteriovenous Fistula
Related terms Arteriovenous Fistula
Enrollment 213 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov