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The Artisse™ Intrasaccular Device is Indicated for the Treatment of Wide-neck Bifurcating Intracranial Aneurysms (IAs).

Study acronym: ARTISSE
StatusRecruiting
PhaseNot applicable
Started
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Record History

See every version on ClinicalTrials.gov ↗

  1. Eligibility criteria expanded, about 26 words
    • Study description revised
    • Site details revised at 1 of 25 sites
  2. Study sites: 23 to 25v32
  3. Study sites: 22 to 23v31
  4. Site details revised at 1 of 22 sitesv30
  5. Trial sites expanded: 19 → 22 locationsv29
Show 27 earlier versionsHide 27 earlier versions
  1. Study sites: 18 to 19v28
  2. Enrollment target: 220 to 300
    • Study sites: 17 to 18
    • Eligibility criteria expanded, about 34 words
    v27
  3. Study sites: 16 to 17v26
  4. Study sites: 13 to 16v25
  5. Study sites: 10 to 13v24
  6. Study sites: 9 to 10v23
  7. Site contacts updated at 1 of 9 sitesv22
  8. Study sites: 8 to 9
    • Primary completion date: Feb 2028 to Aug 2027
    v21
  9. Study sites: 7 to 8v20
  10. Study sites: 4 to 7v19
  11. Study sites: 1 to 4v18
  12. Primary endpoints revised (2)
    • Eligibility criteria expanded, about 23 words
    • Secondary endpoints: details revised at 2 of 8 entries
    • Study title expanded, about 11 words
    v17
  13. Re-verified, no change to tracked fieldsv16
  14. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Apr 2024 to Apr 16, 2024
    • Secondary endpoints revised (8)
    • Site details revised
    v15
  15. Primary completion date: Oct 2026 to Feb 2028v14 Show 10 more changesShow less
    • Start date: Nov 2023 to Apr 2024
    • Primary endpoints revised (2)
    • Enrollment target: 150 to 220
    • Study sites: 0 to 1
    • Study completion date: Nov 2026 to Feb 2032
    • Interventions: Artisse™ (Device) to Artisse™ Intrasaccular Device (Device)
    • Eligibility criteria expanded, about 351 words
    • Secondary endpoints: 4 to 8
    • Study description expanded, about 98 words
    • Study title shortened, about 6 words
  16. Re-verified, no change to tracked fieldsv13
  17. Primary completion date: Oct 2024 to Oct 2026
    • Start date: Nov 2021 to Nov 2023
    • Study completion date: Nov 2024 to Nov 2026
    v12
  18. Primary completion date: Feb 2024 to Oct 2024
    • Start date: Mar 2021 to Nov 2021
    • Study completion date: Mar 2024 to Nov 2024
    v11
  19. Start date: Sep 2020 to Mar 2021
    • Primary completion date: Aug 2023 to Feb 2024
    • Study completion date: Sep 2023 to Mar 2024
    v10
  20. Re-verified, no change to tracked fieldsv9
  21. Primary completion date: Aug 2022 to Aug 2023
    • Start date: Sep 2019 to Sep 2020
    • Study completion date: Sep 2022 to Sep 2023
    v8
  22. Primary completion date: Aug 2021 to Aug 2022
    • Start date: Sep 2018 to Sep 2019
    • Study completion date: Sep 2021 to Sep 2022
    v7
  23. Primary completion date: Sep 2020 to Aug 2021v6 Show 5 more changesShow less
    • Start date: Aug 2017 to Sep 2018
    • Primary endpoints revised (2)
    • Study completion date: Nov 2020 to Sep 2021
    • Eligibility criteria expanded, about 44 words
    • Secondary endpoints: details revised at 4 of 4 entries
  24. Lead sponsor: [Redacted] to Medtronic Neurovascular Clinical Affairsv5 Show 5 more changesShow less
    • Trial status: Withheld to Not Yet Recruiting
    • Primary completion date: Sep 2020
    • Study completion date: Nov 2020
    • Start date: Aug 2017
    • Study title shortened, about 3 words
  25. 3 versions Re-verified since Dec 20, 2016, no change to tracked fieldsv2-v4
  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.
The purpose of this study is to assess the safety and effectiveness of the Artisse™ Intrasaccular Device in the treatment of unruptured and ruptured wide-neck bifurcating intracranial aneurysms.
Trial Details
NCT Number NCT02998229
Lead Sponsor Medtronic Neurovascular Clinical Affairs
Conditions
(from sponsor)		 Intracranial Aneurysm
Related terms Intracranial Aneurysm
Enrollment 300 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov