deltatrials
Active Not Recruiting NA INTERVENTIONAL 1-arm NCT02843633

LEADERS FREE II: BioFreedom™ Pivotal Study

A Prospective Study of the BioFreedom™ Biolimus A9™ Drug Coated Stent in Patients at High Risk for Bleeding

Sponsor: Biosensors Europe SA

Updated 22 times since 2017 Last updated: Feb 1, 2021 Started: Feb 14, 2017 Primary completion: Oct 11, 2018 Completion: Mar 31, 2021
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT02843633, this NA trial focuses on Acute Coronary Syndrome and High Bleeding Risk and remains ongoing. Sponsored by Biosensors Europe SA, it has been updated 22 times since 2017, reflecting substantial change activity. This study contributes longitudinal data to the cardiovascular research landscape.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshot~Feb 2017 – ~Mar 2017 · 28 days · monthly snapshot~Mar 2017 – ~May 2017 · 2 months · monthly snapshot~May 2017 – ~Jun 2017 · 31 days · monthly snapshot~Jun 2017 – ~Jul 2017 · 30 days · monthly snapshot~Jul 2017 – ~Aug 2017 · 31 days · monthly snapshot~Aug 2017 – ~Sep 2017 · 31 days · monthly snapshot~Sep 2017 – ~Oct 2017 · 30 days · monthly snapshot~Oct 2017 – ~Apr 2018 · 6 months · monthly snapshot~Apr 2018 – ~Jun 2018 · 2 months · monthly snapshot~Jun 2018 – ~Feb 2019 · 8 months · monthly snapshot~Feb 2019 – ~Jul 2019 · 5 months · monthly snapshot~Jul 2019 – ~Feb 2020 · 7 months · monthly snapshot~Feb 2020 – ~Mar 2020 · 29 days · monthly snapshot~Mar 2020 – ~Sep 2020 · 6 months · monthly snapshot~Sep 2020 – ~Jan 2021 · 4 months · monthly snapshot~Jan 2021 – ~Mar 2021 · 59 days · monthly snapshot~Mar 2021 – ~Apr 2022 · 13 months · monthly snapshot~Apr 2022 – ~Jul 2024 · 27 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshot~Sep 2025 – present · 10 months · monthly snapshot

Change History

22 versions recorded
  1. Sep 2025 — Present [monthly]

    Active Not Recruiting NA

  2. Sep 2024 — Sep 2025 [monthly]

    Active Not Recruiting NA

  3. Jul 2024 — Sep 2024 [monthly]

    Active Not Recruiting NA

  4. Apr 2022 — Jul 2024 [monthly]

    Active Not Recruiting NA

  5. Mar 2021 — Apr 2022 [monthly]

    Active Not Recruiting NA

Show 17 earlier versions
  1. Jan 2021 — Mar 2021 [monthly]

    Active Not Recruiting NA

  2. Sep 2020 — Jan 2021 [monthly]

    Active Not Recruiting NA

  3. Mar 2020 — Sep 2020 [monthly]

    Active Not Recruiting NA

  4. Feb 2020 — Mar 2020 [monthly]

    Active Not Recruiting NA

  5. Jul 2019 — Feb 2020 [monthly]

    Active Not Recruiting NA

  6. Feb 2019 — Jul 2019 [monthly]

    Active Not Recruiting NA

  7. Jun 2018 — Feb 2019 [monthly]

    Active Not Recruiting NA

  8. Apr 2018 — Jun 2018 [monthly]

    Active Not Recruiting NA

  9. Oct 2017 — Apr 2018 [monthly]

    Active Not Recruiting NA

    Status: RecruitingActive Not Recruiting

  10. Sep 2017 — Oct 2017 [monthly]

    Recruiting NA

  11. Aug 2017 — Sep 2017 [monthly]

    Recruiting NA

  12. Jul 2017 — Aug 2017 [monthly]

    Recruiting NA

  13. Jun 2017 — Jul 2017 [monthly]

    Recruiting NA

  14. May 2017 — Jun 2017 [monthly]

    Recruiting NA

  15. Mar 2017 — May 2017 [monthly]

    Recruiting NA

    Status: Not Yet RecruitingRecruiting

  16. Feb 2017 — Mar 2017 [monthly]

    Not Yet Recruiting NA

    Status: WithheldNot Yet Recruiting

  17. Jan 2017 — Feb 2017 [monthly]

    Withheld NA

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Biosensors Europe SA
Data source: Biosensors Europe SA

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