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

Status: Completed
Location: See all (24) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 22
Maximum Age: 75
Healthy Volunteers: No
View:

• 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

Locations
United States
Arizona
St. Joseph's Hospital and Medical Center
Phoenix
Colorado
Swedish Medical Center / RIA
Englewood
Florida
Lyerly Neurosurgery
Jacksonville
Georgia
Emory University
Atlanta
Illinois
Northwestern University
Chicago
Rush University Medical Center
Chicago
Kentucky
Norton Neuroscience Institute
Louisville
Massachusetts
Tufts Medical Center
Boston
Maryland
The Johns Hopkins Hospital
Baltimore
Minnesota
Abbott Northwestern Hospital
Minneapolis
Mayo Clinic
Rochester
Missouri
Washington University
Saint Louis
New Jersey
Capital Health Hospital
Trenton
New York
Albany Medical Center
Albany
University at Buffalo
Buffalo
North Shore University Hospital
Manhasset
Mount Sinai Health System
New York
Stony Brook University Medical Center
Stony Brook
Pennsylvania
Thomas Jefferson University
Philadelphia
South Carolina
Medical University of South Carolina
Charleston
Tennessee
Methodist University Hospital
Memphis
Texas
Baylor Saint Luke Medical Center
Houston
The Methodist Hospital
Houston
Other Locations
Japan
Institute of Biomedical Research and Innovation
Kobe
Time Frame
Start Date: July 2013
Completion Date: January 2018
Participants
Target number of participants: 145
Treatments
Other: Flow Re-Direction Endoluminal Device
Related Therapeutic Areas
Sponsors
Leads: Microvention-Terumo, Inc.

This content was sourced from clinicaltrials.gov

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