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NCT05409989 · ClinicalTrials.gov registry record · NA
MicroVention, Inc. Flow Re-Direction Endoluminal Device X (FRED™ X™) Post-Approval Study
A NA study of Intracranial Aneurysm, sponsored by Microvention-Terumo.
- Active
- Registry status
- NA
- Development phase
- 154
- Enrollment target
- 20
- Study locations
NCT05409989: Active NA study of Intracranial Aneurysm, sponsored by Microvention-Terumo.
NCT05409989 is a NA study of Intracranial Aneurysm that is active but no longer recruiting, run by Microvention-Terumo. The registered enrollment target is 154 participants, below the 9,185-participant average among 14 other Intracranial Aneurysm trials with a reported enrollment target (98% lower). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05409989, a NA study of Intracranial Aneurysm, is active but no longer recruiting, sponsored by Microvention-Terumo.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 154 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
Major stroke is defined as a new neurological event that persists for \>24 hours and results in a ≥4-point increase in the NIHSS score compared to baseline or compared to any subsequent lower score.
Conditions Studied
Interventions
- DEVICE FRED™ X™
Study Locations (20)
New York
- Albany Medical Center - Albany
- University at Buffalo - Buffalo
- Northwell Health - Manhasset
- Mount Sinai - New York
- Stony Brook University - Stony Brook
- Montefiore Medical Center - The Bronx
Florida
- Memorial Healthcare Systems - Hollywood
- Orlando Health - Orlando
Kentucky
- Baptist Healthcare System - Louisville
- Norton Healthcare - Louisville
Massachusetts
- Massachusetts General Brigham Incorporated - Boston
- UMass Memorial Health - Worcester
Ohio
- Ohio State University - Columbus
- ProMedica Toledo Hospital - Toledo
Hawaii
- Queen's Medical Center - Honolulu
Iowa
- University of Iowa - Iowa City
Kansas
- University of Kansas - Kansas City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 154 participants |
| Start Date | 2022-09-20 |
| Est. Completion | 2029-11 |
| Phase | NA |
What the registry record for NCT05409989 still lists
NCT05409989 is an interventional study that assigns participants to a tested intervention. The registered 154 participants enrollment target is mid-sized for trials with a published cap, below the 9,185-participant average among 14 other Intracranial Aneurysm trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Intracranial Aneurysm appearing as the primary indexed condition, and to 1 intervention - of which FRED™ X™ is the first listed.
NCT05409989 names 20 study sites across 11 states, led by New York, Florida, Kentucky.
Frequently Asked Questions
What is clinical trial NCT05409989 about?
NCT05409989 is a clinical study titled "MicroVention, Inc. Flow Re-Direction Endoluminal Device X (FRED™ X™) Post-Approval Study". 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 b...
What is the current status of trial NCT05409989?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 154 participants. The study started on 2022-09-20. Estimated completion is 2029-11.
What conditions does trial NCT05409989 study?
This clinical trial studies the following conditions: Intracranial Aneurysm.
What interventions are being tested in trial NCT05409989?
The interventions under investigation include: FRED™ X™ (DEVICE).
Who is sponsoring clinical trial NCT05409989?
This trial is sponsored by Microvention-Terumo, which has 9 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05409989 being conducted?
This trial has 20 study locations across Florida, Hawaii, Iowa, Kansas, Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05409989's enrollment target sits among peer trials
154 12th of 14 higher than 3 of 14 other Intracranial Aneurysm trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Intracranial Aneurysm trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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