deltatrials
Terminated OBSERVATIONAL NCT02043951

Use and Safety of the LUTONIX® Drug Coated Balloon Catheter in Arteries of the Lower Extremity (LEG)

A Prospective, Multicenter, Single Arm, Post-Market, Real-World Global Registry Assessing the Clinical Use and Safety of the LUTONIX Drug Coated Balloon Catheter in Arteries of the Lower Extremity (LUTONIX® Lower Extremity Global (LEG) Registry)

Sponsor: C. R. Bard

Updated 6 times since 2017 Last updated: Jul 12, 2016 Started: Jan 31, 2014 Primary completion: Dec 31, 2015 Completion: Jan 31, 2016
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Terminated

Originally 500 patients were planned but only 59 have been enrolled

This observational or N/A phase trial investigates Peripheral Artery Disease and is currently terminated or withdrawn. C. R. Bard leads this study, which shows 6 recorded versions since 2014 — indicating limited longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Status Flow

~Jan 2017 – ~Apr 2018 · 15 months · monthly snapshotTerminated~Apr 2018 – ~Jun 2018 · 2 months · monthly snapshotTerminated~Jun 2018 – ~Jan 2021 · 31 months · monthly snapshotTerminated~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshotTerminated~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotTerminated~Sep 2024 – present · 22 months · monthly snapshotTerminated

Change History

6 versions recorded
  1. Sep 2024 — Present [monthly]

    Terminated

  2. Jul 2024 — Sep 2024 [monthly]

    Terminated

  3. Jan 2021 — Jul 2024 [monthly]

    Terminated

  4. Jun 2018 — Jan 2021 [monthly]

    Terminated

  5. Apr 2018 — Jun 2018 [monthly]

    Terminated

    Phase: PHASE3None

Show 1 earlier version
  1. Jan 2017 — Apr 2018 [monthly]

    Terminated PHASE3

    First recorded

Jan 2014

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 .