Status:
COMPLETED
Pivotal Study of the FRED Stent System in the Treatment of Intracranial Aneurysms
Lead Sponsor:
Microvention-Terumo, Inc.
Conditions:
Intracranial Aneurysms
Eligibility:
All Genders
22-75 years
Phase:
NA
Brief 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 aneu...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2018
Estimated Enrollment :
145 Patients enrolled
Trial Details
Trial ID
NCT01801007
Start Date
July 1 2013
End Date
January 1 2018
Last Update
March 8 2021
Active Locations (24)
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1
St. Joseph's Hospital and Medical Center
Phoenix, Arizona, United States, 85013
2
Swedish Medical Center / RIA
Englewood, Colorado, United States, 80113
3
Lyerly Neurosurgery
Jacksonville, Florida, United States, 32207
4
Emory University
Atlanta, Georgia, United States, 30322