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Pivotal Study of the FRED Stent System in the Treatment of Intracranial Aneurysms | Clinical Trials | Clareo Health

COMPLETEDNA

Pivotal Study of the FRED Stent System in the Treatment of Intracranial Aneurysms

Pivotal Study of the MicroVention Flow Re-Direction Endoluminal Device (FRED) Stent System in the Treatment of Intracranial Aneurysms

NCT01801007•Microvention-Terumo, Inc.

View on ClinicalTrials.gov

Summary

The purpose of this study is to evaluate the safety and effectiveness of the MicroVention Flow Redirection Intraluminal Device (FRED) system when used in the treatment of wide-necked intracranial aneurysms.

Eligibility

Age

22 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Participant whose age ≥ 22 and ≤75 years
•Participant has single target aneurysm located in the internal carotid artery
•Participant sign and date an IRB/EC approved informed consent prior initiation of any study procedures

Exclusion Criteria

•Participant who suffers from an intracranial hemorrhage in the last 30 days
•Participant who suffers from a subarachnoid hemorrhage in the last 60 days
•Participant with symptomatic extracranial mass or currently undergoing radiation therapy for tumor of the head and neck region
•Participant who is pregnant or breastfeeding
•Participant has an arteriovenous malformation (AVM) in the area of the target aneurysm

Locations (24)

St. Joseph's Hospital and Medical Center

Phoenix, Arizona, United States

Swedish Medical Center / RIA

Englewood, Colorado, United States

Lyerly Neurosurgery

Jacksonville, Florida, United States

Emory University

Atlanta, Georgia, United States

Northwestern University

Chicago, Illinois, United States

Rush University Medical Center

Chicago, Illinois, United States

Norton Neuroscience Institute

Louisville, Kentucky, United States

The Johns Hopkins Hospital

Baltimore, Maryland, United States

Tufts Medical Center

Boston, Massachusetts, United States

Abbott Northwestern Hospital

Minneapolis, Minnesota, United States

Key Dates

Start Date

July 1, 2013

Primary Completion Date

January 1, 2018

Completion Date

January 1, 2018

Last Updated

March 8, 2021

Enrollment

145

ACTUAL participants

Conditions

Intracranial Aneurysms

Interventions

Flow Re-Direction Endoluminal Device (FRED)

DEVICE

Targeting Real World Usage In Stroke Treatment

NCT07474935

Saccular and Fusiform AneurysmsPseudoaneurysm+7 more

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COMPLETED

TRAIL: Treatment of Intracranial Aneurysms With LVIS® System

NCT02921711

Intracranial Aneurysms

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COMPLETEDNA

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 8, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Pivotal Study of the FRED Stent System in the Treatment of Intracranial Aneurysms

Inclusion Criteria

Exclusion Criteria

Targeting Real World Usage In Stroke Treatment

TRAIL: Treatment of Intracranial Aneurysms With LVIS® System

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