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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.

Must not have

Presence of any of the following unequivocal cardiac sources of embolism: chronic or paroxysmal atrial fibrillation, mitral stenosis, mechanical valve, endocarditis, intracardiac clot or vegetation, myocardial infarction within 3 months, dilated cardiomyopathy, left atrial spontaneous echo contrast, ejection fraction less than 30%.

Subject with symptomatic extracranial or intracranial stenosis of the parent artery (>50%) proximal to the target aneurysm.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

No Placebo-Only Group

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.

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.

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.

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a heart condition that could cause blood clots.

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I have a narrowed artery near my brain aneurysm.

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I have a bleeding disorder or low platelet count that prevents me from taking blood thinners.

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I have a history of major bleeding or currently have signs of active bleeding.

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I have a tumor in my brain or am receiving radiation for head/neck cancer.

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I cannot have treatments through my groin due to missing pulses or other reasons.

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I have not had a brain bleed in the last 30 days.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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.