Clinical Trial

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

Active, Not Recruiting
View on ClinicalTrials.gov →
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.
Summary
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.
Protocol Amendment History 8 amendments
This ClinicalTrials.gov record has been amended 8 times since 2022-06-04; most recent amendment 2026-03-23.
Status change: Recruiting → Active, Not Recruiting 2025-04-09
Status change: Not Yet Recruiting → Recruiting 2023-02-27
Trial Details
NCT Number NCT05409989
Lead Sponsor Microvention-Terumo, Inc.
Conditions Intracranial Aneurysm
Enrollment 154 participants
Start Date 2022-09-20
Primary Completion 2026-04 (estimated)
Study Completion 2030-05 (estimated)
Updated on ClinicalTrials.gov 2026-03-24