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Flow Diverters

FRED™ X™ Device for Brain Aneurysm

N/A
Recruiting
Research Sponsored by Microvention-Terumo, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
The subject has a modified Rankin Scale (mRS) ≤ 2.
The subject has a wide-necked ( ≥4mm or dome-to-neck ratio <2) saccular or fusiform aneurysm.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

Study Summary

This trial compares two devices to see if one is more effective and safe than the other. Results will be compared to a previous study.

Who is the study for?
This trial is for adults with a wide-necked brain aneurysm located in the internal carotid artery, who are not pregnant or breastfeeding, can undergo imaging without allergic reactions, and have no major heart issues or bleeding disorders. Participants must be able to attend follow-up visits for up to 5 years and sign consent forms.Check my eligibility
What is being tested?
The FRED™ X™ device is being tested in this study. It's designed to treat brain aneurysms by redirecting blood flow. The performance of FRED™ X™ will be compared with the original FRED™ device based on previously established goals from the pivotal study of the latter.See study design
What are the potential side effects?
While specific side effects are not listed here, similar devices may cause complications like reaction to contrast dye used during imaging, infection risks post-procedure, clotting issues around the device area, or potential impact on surrounding blood vessels.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can carry out all my usual duties with no more than slight disability.
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My aneurysm is wide-necked or fusiform.
Select...
The artery near my brain aneurysm is between 2.0 and 5.0 mm wide.
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I have one aneurysm in a specific part of the artery in my neck.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Primary Effectiveness Endpoint: The percent of subjects with (1) complete (100%) occlusion of the target aneurysm and ≤50% stenosis of the parent artery at the target IA, and (2) in whom an alternative treatment of the target IA had not been performed.
Primary Safety Endpoint Part 1: Proportion of subjects that experience either Death or major stroke within 30 days post-procedure.
Primary Safety Endpoint Part 2: Proportion of subjects that experience neurological death or major ipsilateral stroke within 12 months post-procedure.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Flow Re-Direction Endoluminal Device XExperimental Treatment1 Intervention
FRED™ X™ device

Find a Location

Who is running the clinical trial?

Microvention-Terumo, Inc.Lead Sponsor
29 Previous Clinical Trials
6,127 Total Patients Enrolled

Media Library

FRED™ X™ (Flow Diverters) Clinical Trial Eligibility Overview. Trial Name: NCT05409989 — N/A
Brain Aneurysm Research Study Groups: Flow Re-Direction Endoluminal Device X
Brain Aneurysm Clinical Trial 2023: FRED™ X™ Highlights & Side Effects. Trial Name: NCT05409989 — N/A
FRED™ X™ (Flow Diverters) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05409989 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many medical facilities are conducting this trial currently?

"Ten trial sites have been approved to participate, including Ohio Health Riverside Research Institute in Columbus, University of Iowa in Iowa City and Memorial Healthcare Systems in Hollywood. Additionally there are 7 other locales that can enrol patients."

Answered by AI

To what extent is this clinical trial enrolling patients?

"Affirmative. Clinicaltrials.gov displays that this trial is presently recruiting participants, with 154 individuals sought in 10 different medical centres since its original posting on September 20th 2022 and last update April 20th of the following year."

Answered by AI

Are there still patient slots open for this trial?

"Affirmative. As indicated on clinicaltrials.gov, this research is actively seeking participants to enroll in the study. The initial post was made September 20th of 2022 and it has since been updated April 20th of 2023. An estimated 154 people are needed from 10 different trial sites."

Answered by AI

Does the research extend to persons of advanced age?

"Participants who meet the age criteria of being over 22 years old and below 75 years are welcome to join this clinical trial."

Answered by AI

Is eligibility for this experiment open to participants?

"This medical trial seeks 154 participants aged 22 to 75 with brain aneurysms. In order to qualify, the patient must have a single target aneurysm in the internal carotid artery from petrous segment to its termination point and feature a wide-necked ( ≥4mm or dome-to-neck ratio <2) saccular or fusiform structure."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
MicroVention, Inc. Flow Re-Direction Endoluminal Device X (FRED™ X™) Post-Approval Study
2022. "MicroVention, Inc. Flow Re-Direction Endoluminal Device X (FRED™ X™) Post-Approval Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05409989.
~103 spots leftby Sep 2029
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