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Trial #NCT01801007
Intracranial Aneurysms Clinical Trials

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
Study ID: CL12001; Secondary ID: G120111; Source: Microvention-Terumo, Inc.
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Definitions
Interventional trials
Determine whether experimental treatments or new ways of using known therapies are safe and effective under controlled environments.
Observational trials
Address health issues in large groups of people or populations in natural settings.
Recruiting
Participants are currently being recruited and enrolled.
Active, not recruiting
Study is ongoing (i.e., patients are being treated or examined), but enrollment has completed.
Not yet recruiting
Participants are not yet being recruited or enrolled.
Enrolling by invitation
Participants are being (or will be) selected from a predetermined population.
Completed
The study has concluded normally; participants are no longer being examined or treated (i.e., last patient's last visit has occurred).
Withdrawn
Study halted prematurely, prior to enrollment of first participant.
Suspended
Recruiting or enrolling participants has halted prematurely but potentially will resume.
Terminated
Recruiting or enrolling participants has halted prematurely and will not resume; participants are no longer being examined or treated.
Status Recruiting
Country United States
Study type Interventional
Enrollment 127
Start date July 2013
Completion date April 2015
Phase Phase 2/Phase 3
Sponsor Microvention-Terumo, Inc.
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:
Gender: Both
Age: 22 Years - 75 Years
Inclusion Criteria:
- Subject whose age= 22and =75 years
- Subject has single target aneurysm located in the internal carotid artery
- Subject fulfills study requirements and his/her legally authorized representative provides a signed informed consent form
Exclusion Criteria:
- Subject who suffers from an intracranial hemorrhage in the last 30 days
- Subject who suffers from a subarachnoid hemorrhage in the last 60 days
- Subject with symptomatic extracranial mass or currently undergoing radiation therapy for tumor of the head and nexk region
- Subject who is pregnant or breastfeeding
- Subject has an arteriovenous malformation (AVM)in the area of the target aneurysm
Outcome:
Primary outcome
  • Proportion of subjects who experience neurological death or major ipsilateral stroke measured by the modified Rankin Scale(mRS)and the National Institute of Health Stroke Scale (NIHSS)
    Time frame: 12 months
Secondary outcome
  • Incidence of FRED system and procedure related serious adverse events
    Time frame: 12 months
Contacts:
  • Cameron McDougall, MD; Barrow Neurological Institute (Principal Investigator)
  • Vinny Podichetty;
    Phone: 7142478043
Location Country Status
Abbott Northwestern / Allina Health Minneapolis, Minnesota United States Recruiting
Albany Medical Center Albany, New York United States Recruiting
Barnes Jewish Hospital St. Louis, Missouri United States Recruiting
Barrow Neurological Institute Phoenix, Arizona United States Recruiting
Capital Health Regional Medical Center Trenton, New Jersey United States Recruiting
Emory University Atlanta, Georgia United States Recruiting
Johns Hopkins University School of Medicine The Johns Hopkins Hospital Baltimore, Maryland United States Recruiting
Lyerly Baptist Jacksonville, Florida United States Recruiting
Methodist Memphis - Semmes Murphy Memphis, Tennessee United States Recruiting
Mt. Sinai Roosevelt Hospital NY, New York United States Recruiting
North Shore University Hospital Manhasset, New York United States Recruiting
Northwestern University Chicago, Illinois United States Recruiting
Rush University Medical Center Chicago, Illinois United States Recruiting
St. Luke's Methodist Hospital Houston, Texas United States Recruiting
Stony Brook University Medical Center Stony Brook, New York United States Recruiting
Swedish Medical Center Englewood, Colorado United States Recruiting
The Medical University of South Carolina Charleston, South Carolina United States Recruiting
The Methodist Hospital Houston, Texas United States Recruiting
Thomas Jefferson University Philadelphia, Pennsylvania United States Recruiting
Tufts University Boston, Massachusetts United States Recruiting
UCLA Los Angeles, California United States Recruiting
University at Buffalo Buffalo, New York United States Recruiting
Sponsors:
  • Microvention-Terumo, Inc. - (Lead Sponsor)

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