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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Microvention-Terumo, Inc.
Sponsor:
Information provided by (Responsible Party):
Microvention-Terumo, Inc.
ClinicalTrials.gov Identifier:
NCT01801007
First received: February 26, 2013
Last updated: June 27, 2014
Last verified: June 2014
  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 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

  Eligibility

Ages Eligible for Study:   22 Years to 75 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

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

Contacts
Contact: Vinny Podichetty 7142478043 vinny.podichetty@microvention.com

  Hide Study Locations
Locations
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: Polly Kay, RN, CCRP       pkay@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, Florida
Lyerly Baptist Recruiting
Jacksonville, Florida, United States, 32207
Contact: Nancy Ebreo, CCRC       NEbreo@jaxheart.com   
Principal Investigator: Ricardo Hanel, MD, PhD         
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         
Mt. Sinai 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, Pennsylvania
Thomas Jefferson University Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Jan Jaeger, Ph.D.       Jan.Jaeger@jefferson.edu   
Principal Investigator: Pascal M. Jabbour, 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.
Investigators
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: June 27, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on October 19, 2014