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MicroVention, Inc. Flow Re-Direction Endoluminal Device X (FRED™ X™) Post-Approval Study

StatusActive, Not Recruiting
PhaseNot applicable
Started
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Record status
This record was last updated March 24, 2026 (before its estimated April 2026 completion). Its status may not reflect the trial's current state.

Record History

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  1. Primary completion date: Sep 2029 to Apr 2026
    • Study completion date: Nov 2029 to May 2030
    v9
  2. Study sites: 25 to 23v8
  3. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 25 of 25 sites
    v7
  4. Study sites: 24 to 25v6
  5. Study sites: 21 to 24v5
Show 3 earlier versionsHide 3 earlier versions
  1. Study sites: 10 to 21v4
  2. Study sites: 6 to 10v3
  3. Trial status: Not Yet Recruiting to Recruiting
    • Primary endpoints revised (3)
    • Start date changed from estimate of Sep 2022 to Sep 20, 2022
    v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 objective of this study is to generate contemporaneous clinical data to facilitate a reasonable comparison of the performance of the FRED™ X™ device with the performance of the FRED™ device. The data generated from this study will be compared to the safety and effectiveness of the FRED™ device by meeting the same performance goals (PGs) established for the FRED™ pivotal study.
Trial Details
NCT Number NCT05409989
Lead Sponsor Microvention-Terumo, Inc.
Conditions
(from sponsor)		 Intracranial Aneurysm
Related terms Intracranial Aneurysm
Enrollment 154 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov