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

This study is currently recruiting participants.
Verified April 2014 by Microvention-Terumo, Inc.
Information provided by (Responsible Party):
Microvention-Terumo, Inc.
ClinicalTrials.gov Identifier:
First received: February 26, 2013
Last updated: April 1, 2014
Last verified: April 2014

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 2
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Incidence of FRED system and procedure related serious adverse events [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

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

Estimated Enrollment: 127
Study Start Date: July 2013
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Flow Re-Direction Endoluminal Device Device: Flow Re-Direction Endoluminal Device


Ages Eligible for Study:   22 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01801007

Contact: Kathy Akagha, MPH 7142478183 kathy.akagha@microvention.com
Contact: Vinny Podichetty, MD 7142478043 vinny.podichetty@microvention.com

United States, Arizona
Barrow Neurological Institute Recruiting
Phoenix, Arizona, United States, 85013
Contact: Cheryl Kelly, RN       cheryl.kelly@dignityhealth.org   
Principal Investigator: Cameron McDougall, MD         
United States, California
UCLA Recruiting
Los Angeles, California, United States, 90095
Contact: Roslynn Marzan-McGill, CCRP       rmcgill@mednet.ucla.edu   
Principal Investigator: Reza Jahan, MD         
United States, Colorado
Swedish Medical Center Recruiting
Englewood, Colorado, United States, 80113
Contact: Ashley Bitner       ABitner@theCNI.org   
Principal Investigator: Donald Frei, MD         
United States, Georgia
Emory University Recruiting
Atlanta, Georgia, United States, 30322
Contact: Maria Rivas       mrivas2@emory.edu   
Principal Investigator: Jacques E Dion, MD         
United States, Illinois
Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Contact: Byron Yip       BYip@nmff.org   
Principal Investigator: Bernard Bendok, MD         
Rush University Medical Center Recruiting
Chicago, Illinois, United States, 60612
Contact: Christy Anton       Christy_Anton@rush.edu   
Principal Investigator: Demetrius Lopes, MD         
United States, Maryland
Johns Hopkins University School of Medicine The Johns Hopkins Hospital Recruiting
Baltimore, Maryland, United States, 21287
Contact: Barbara Michniewicz, RN       bwawrys1@jhmi.edu   
Principal Investigator: Alexander Coon, MD         
United States, Massachusetts
Tufts University Recruiting
Boston, Massachusetts, United States, 02111
Contact: Michelle Bettle       MBettle@tuftsmedicalcenter.org   
Principal Investigator: Adel Malek, MD, PhD         
United States, Minnesota
Abbott Northwestern / Allina Health Recruiting
Minneapolis, Minnesota, United States, 55407
Contact: Jennifer Fease, CCRC       jennifer.fease@allina.com   
Principal Investigator: Yasha Kadkhodayan, MD         
United States, Missouri
Barnes Jewish Hospital Recruiting
St. Louis, Missouri, United States, 63110
Contact: Eileen Jacobs, R.T.(R)(M)       jacobse@mir.wustl.edu   
Principal Investigator: Christopher Moran, MD         
United States, New Jersey
Capital Health Regional Medical Center Recruiting
Trenton, New Jersey, United States, 08638
Contact: Cynthia Diaz, RN, MHA       CDiaz@capitalhealth.org   
Principal Investigator: Erol Veznedaroglu, MD, FAANS, FACS, FAHA         
United States, New York
Albany Medical Center Recruiting
Albany, New York, United States, 12208
Contact: Linda Graca, RN       gracal@mail.amc.edu   
Principal Investigator: Alan Boulos, MD         
University at Buffalo Recruiting
Buffalo, New York, United States, 14203
Contact: Dawn Holler       dholler@ubns.com   
Principal Investigator: Adnan Siddiqui, MD, PhD         
North Shore University Hospital Recruiting
Manhasset, New York, United States, 11030
Contact: Kimberly Lombardo, RN       KLombardo2@NSHS.edu   
Principal Investigator: Avi Setton, MD         
St. Luke's Roosevelt Hospital Recruiting
NY, New York, United States, 10019
Contact: Ahmed Otokiti, M.B, B.S.       aotokiti@CHPNET.ORG   
Principal Investigator: Johanna FiFi, MD         
Stony Brook University Medical Center Recruiting
Stony Brook, New York, United States, 11794
Contact: Marlene Baumeister, RN       Marlene.Baumeister@stonybrookmedical.edu   
Principal Investigator: Henry Woo, MD         
United States, South Carolina
The Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Adrian Parker       parkerad@musc.edu   
Principal Investigator: Aquilla Turk, DO         
United States, Tennessee
Methodist Memphis - Semmes Murphy Recruiting
Memphis, Tennessee, United States, 38104
Contact: Hani Rashed, MD, CCRP       Hani.Rashed@mlh.org   
Principal Investigator: Adam Arthur, MD, MPH         
United States, Texas
St. Luke's Methodist Hospital Recruiting
Houston, Texas, United States, 77030
Contact: Coimbatore "Sree" Vidya, MS       csreevidya@sleh.com   
Principal Investigator: Michel Mawad, MD         
The Methodist Hospital Recruiting
Houston, Texas, United States, 77030
Contact: Melissa Whipple, RN       mbwhipple@houstonmethodist.org   
Principal Investigator: Orlando Diaz, MD         
Sponsors and Collaborators
Microvention-Terumo, Inc.
Principal Investigator: Cameron McDougall, MD Barrow Neurological Institute
  More Information

No publications provided

Responsible Party: Microvention-Terumo, Inc.
ClinicalTrials.gov Identifier: NCT01801007     History of Changes
Other Study ID Numbers: CL12001, G120111
Study First Received: February 26, 2013
Last Updated: April 1, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on April 16, 2014