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MicroVention, Inc. Flow Re-Direction Endoluminal Device X (FRED™ X™) Post-Approval Study
NCT05409989 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05409989
The ClinicalTrials.gov registry entry for NCT05409989 describes a study currently listed as active not recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 154 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Microvention-Terumo, which has 5 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05409989 reports 20 study locations spanning 11 distinct geographic areas — top geographies include New York, Florida, Kentucky. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05409989?
The interventions under investigation include: FRED™ X™ (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05409989?
This trial is sponsored by Microvention-Terumo, which has 5 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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