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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01801007
First Posted: February 28, 2013
Last Update Posted: August 31, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Microvention-Terumo, Inc.
  Purpose
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.

Condition Intervention Phase
Intracranial Aneurysms Device: Flow Re-Direction Endoluminal Device Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pivotal Study of the MicroVention Flow Re-Direction Endoluminal Device (FRED) Stent System in the Treatment of Intracranial Aneurysms

Resource links provided by NLM:


Further study details as provided by Microvention-Terumo, Inc.:

Primary Outcome Measures:
  • 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 Measures:
  • Incidence of FRED system and procedure related serious adverse events [ Time Frame: 12 months ]

Other Outcome Measures:
  • Proportion of subjects with complete occlusion of the target aneurysm and ≤50% stenosis of the parent artery [ Time Frame: 12 months ]

Estimated Enrollment: 195
Study Start Date: July 2013
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Flow Re-Direction Endoluminal Device Device: Flow Re-Direction Endoluminal Device

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   22 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01801007


  Hide Study Locations
Locations
United States, Arizona
Barrow Neurological Institute
Phoenix, Arizona, United States, 85013
United States, California
UCLA
Los Angeles, California, United States, 90095
United States, Colorado
Swedish Medical Center
Englewood, Colorado, United States, 80113
United States, Florida
Lyerly Baptist
Jacksonville, Florida, United States, 32207
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
Rush University Medical Center
Chicago, Illinois, United States, 60612
United States, Maryland
Johns Hopkins University School of Medicine The Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Tufts University
Boston, Massachusetts, United States, 02111
United States, Minnesota
Abbott Northwestern / Allina Health
Minneapolis, Minnesota, United States, 55407
United States, Missouri
Barnes Jewish Hospital
Saint Louis, Missouri, United States, 63110
United States, New Jersey
Capital Health Regional Medical Center
Trenton, New Jersey, United States, 08638
United States, New York
Albany Medical Center
Albany, New York, United States, 12208
University at Buffalo
Buffalo, New York, United States, 14203
North Shore University Hospital
Manhasset, New York, United States, 11030
Mt. Sinai Roosevelt Hospital
New York, New York, United States, 10019
Stony Brook University Medical Center
Stony Brook, New York, United States, 11794
United States, Pennsylvania
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
United States, South Carolina
The Medical University of South Carolina
Charleston, South Carolina, United States, 29425
United States, Tennessee
Methodist Memphis - Semmes Murphy
Memphis, Tennessee, United States, 38104
United States, Texas
St. Luke's Methodist Hospital
Houston, Texas, United States, 77030
The Methodist Hospital
Houston, Texas, United States, 77030
Sponsors and Collaborators
Microvention-Terumo, Inc.
Investigators
Principal Investigator: Cameron McDougall, MD
  More Information

Responsible Party: Microvention-Terumo, Inc.
ClinicalTrials.gov Identifier: NCT01801007     History of Changes
Other Study ID Numbers: CL12001
G120111 ( Other Identifier: FDA )
First Submitted: February 26, 2013
First Posted: February 28, 2013
Last Update Posted: August 31, 2017
Last Verified: August 2017

Additional relevant MeSH terms:
Aneurysm
Intracranial Aneurysm
Vascular Diseases
Cardiovascular Diseases
Intracranial Arterial Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases