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Evaluation of Safety and Effectiveness of Stryker Surpass Evolve™ Flow Diverter System

Study acronym: EVOLVE
StatusActive, Not Recruiting
PhaseNot applicable
Started
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Record History

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  1. Re-verified, no change to tracked fieldsv24
  2. Primary completion date: Sep 11, 2024 to Jul 14, 2025v23
  3. Primary completion date changed from estimate of Dec 13, 2024 to Sep 11, 2024v22
  4. Enrollment target: 249 to 248
    • Primary completion date: Sep 13, 2024 to Dec 13, 2024
    • Study sites revised (37)
    v21
  5. Re-verified, no change to tracked fieldsv20
Show 18 earlier versionsHide 18 earlier versions
  1. Primary completion date: Jul 28, 2023 to Sep 13, 2024v19 Show 4 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 235 to confirmed 249
    • Study sites: 40 to 37
    • Study completion date: Jul 31, 2025 to Sep 13, 2028
  2. Study sites: 39 to 40v18
  3. Study sites: 38 to 39v17
  4. Re-verified, no change to tracked fieldsv16
  5. Study sites: 37 to 38
    • Eligibility criteria expanded, about 14 words
    v15
  6. Study sites: 36 to 37v14
  7. Study sites: 21 to 36v13
  8. Re-verified, no change to tracked fieldsv12
  9. Study sites: 14 to 21
    • Study description expanded, about 36 words
    v11
  10. Primary completion date: Sep 2022 to Jul 28, 2023
    • Enrollment target: 250 to 235
    • Study sites: 13 to 14
    • Study completion date: Sep 2024 to Jul 31, 2025
    v10
  11. Study sites: 12 to 13v9
  12. Study sites: 8 to 12
    • Study title shortened, about 6 words
    v8
  13. Enrollment target: 235 to 250
    • Study sites: 7 to 8
    • Eligibility criteria revised
    v7
  14. Study sites: 3 to 7
    • Start date changed from estimate of Jul 2020 to Jul 7, 2020
    v6
  15. Study sites: 1 to 3
    • Start date: Jun 2020 to Jul 2020
    v5
  16. Start date: Mar 2020 to Jun 2020v4
  17. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    v3
  18. Start date: Feb 2020 to Mar 2020v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 primary objective of this study is to evaluate the safety and effectiveness of the Surpass™ Evolve Flow Diverter System in the treatment of unruptured, wide-neck intracranial aneurysms measuring ≤ 12 mm and located on the ICA or its branches
Trial Details
NCT Number NCT04195568
Lead Sponsor Stryker Neurovascular
Conditions
(from sponsor)		 Aneurysm, Intracranial
Related terms Intracranial Aneurysm
Enrollment 248 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov