Pivotal Study of the FRED Stent System in the Treatment of Intracranial Aneurysms
NCT ID: NCT01801007
Last Updated: 2021-03-08
Study Results
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View full resultsBasic Information
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COMPLETED
NA
145 participants
INTERVENTIONAL
2013-07-31
2018-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Flow Re-Direction Endoluminal Device
Flow Re-Direction Endoluminal Device (FRED)
Interventions
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Flow Re-Direction Endoluminal Device (FRED)
Eligibility Criteria
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Inclusion Criteria
* 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 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
22 Years
75 Years
ALL
No
Sponsors
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Microvention-Terumo, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Cameron McDougall, MD
Role: PRINCIPAL_INVESTIGATOR
Johns Hopkins University
Locations
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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
Mayo Clinic
Rochester, Minnesota, United States
Washington University
St Louis, Missouri, United States
Capital Health Hospital
Trenton, New Jersey, United States
Albany Medical Center
Albany, New York, United States
University at Buffalo
Buffalo, New York, United States
North Shore University Hospital
Manhasset, New York, United States
Mount Sinai Health System
New York, New York, United States
Stony Brook University Medical Center
Stony Brook, New York, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Methodist University Hospital
Memphis, Tennessee, United States
Baylor Saint Luke Medical Center
Houston, Texas, United States
The Methodist Hospital
Houston, Texas, United States
Institute of Biomedical Research and Innovation
Kobe, , Japan
Countries
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References
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McDougall CG, Diaz O, Boulos A, Siddiqui AH, Caplan J, Fifi JT, Turk AS, Kayan Y, Jabbour P, Kim LJ, Hetts SW, Cooke DL, Dowd CF. Safety and efficacy results of the Flow Redirection Endoluminal Device (FRED) stent system in the treatment of intracranial aneurysms: US pivotal trial. J Neurointerv Surg. 2022 Jun;14(6):577-584. doi: 10.1136/neurintsurg-2021-017469. Epub 2021 Jul 19.
Provided Documents
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Document Type: Statistical Analysis Plan
Document Type: Study Protocol
Other Identifiers
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G120111
Identifier Type: OTHER
Identifier Source: secondary_id
CL12001
Identifier Type: -
Identifier Source: org_study_id
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