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

Completed · Not applicable

Conditions studied: Intracranial Aneurysms

In brief

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.

Key facts

Study ID

NCT01801007

Run by

Microvention-Terumo, Inc.

People needed

145

Starts

2013-07-01

Expected to finish

2018-01-01

Last updated by the study team

2021-03-08

Who can join

Age: 22 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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