deltatrials
Completed PHASE3 INTERVENTIONAL 2-arm NCT02440022

Study Comparing Lutonix AV Drug Coated Balloon vs Standard Balloon for Treatment of Dysfunctional AV Fistulae

A Prospective, Global, Multicenter, Randomized, Controlled Study Comparing Lutonix® 035 AV Drug Coated Balloon PTA Catheter vs. Standard Balloon PTA Catheter for the Treatment of Dysfunctional AV Fistulae

Sponsor: C. R. Bard

Conditions Arteriovenous Fistula
Interventions Lutonix DCB Percutaneous Transluminal Angiography Standard Balloon Angioplasty Catheter
Updated 14 times since 2017 Last updated: Apr 27, 2020 Started: Jun 30, 2015 Primary completion: Sep 30, 2016 Completion: Jun 30, 2018
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT02440022, this PHASE3 trial focuses on Arteriovenous Fistula and remains completed. Sponsored by C. R. Bard, it has been updated 14 times since 2015, reflecting substantial change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshot~Feb 2017 – ~Jun 2017 · 4 months · monthly snapshot~Jun 2017 – ~Sep 2017 · 3 months · monthly snapshot~Sep 2017 – ~Jun 2018 · 9 months · monthly snapshot~Jun 2018 – ~Jul 2018 · 30 days · monthly snapshot~Jul 2018 – ~Aug 2018 · 31 days · monthly snapshot~Aug 2018 – ~Dec 2018 · 4 months · monthly snapshot~Dec 2018 – ~Jun 2020 · 18 months · monthly snapshot~Jun 2020 – ~Jan 2021 · 7 months · monthly snapshot~Jan 2021 – ~Dec 2022 · 23 months · monthly snapshot~Dec 2022 – ~Jan 2023 · 31 days · monthly snapshot~Jan 2023 – ~Jul 2024 · 18 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – present · 22 months · monthly snapshot

Change History

14 versions recorded

  1. Sep 2024 — Present [monthly]

    Completed PHASE3

  2. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE3

  3. Jan 2023 — Jul 2024 [monthly]

    Completed PHASE3

  4. Dec 2022 — Jan 2023 [monthly]

    Completed PHASE3

  5. Jan 2021 — Dec 2022 [monthly]

    Completed PHASE3

▶ Show 9 earlier versions

  1. Jun 2020 — Jan 2021 [monthly]

    Completed PHASE3

  2. Dec 2018 — Jun 2020 [monthly]

    Completed PHASE3

    Status: Active Not Recruiting → Completed

  3. Aug 2018 — Dec 2018 [monthly]

    Active Not Recruiting PHASE3

  4. Jul 2018 — Aug 2018 [monthly]

    Active Not Recruiting PHASE3

  5. Jun 2018 — Jul 2018 [monthly]

    Active Not Recruiting PHASE3

  6. Sep 2017 — Jun 2018 [monthly]

    Active Not Recruiting PHASE3

  7. Jun 2017 — Sep 2017 [monthly]

    Active Not Recruiting PHASE3

  8. Feb 2017 — Jun 2017 [monthly]

    Active Not Recruiting PHASE3

  9. Jan 2017 — Feb 2017 [monthly]

    Active Not Recruiting PHASE3

    First recorded

Jun 2015

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • C. R. Bard
Data source: C. R. Bard

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Birmingham, United States , Boston, United States , Charleston, United States , Charlottesville, United States , Chicago, United States , Flint, United States , Fort Worth, United States , Madison, United States , Memphis, United States , New Brighton, United States and 13 more locations