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

This study is not yet open for participant recruitment.
Verified February 2013 by Microvention-Terumo, Inc.
Sponsor:
Information provided by (Responsible Party):
Microvention-Terumo, Inc.
ClinicalTrials.gov Identifier:
NCT01801007
First received: February 26, 2013
Last updated: February 27, 2013
Last verified: February 2013
History of Changes
  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:

U.S. FDA Resources

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

Contacts
Contact: Lucie Thibault, Pharm.D. lucie.thibault@microvention.com
Contact: Anne Marie Carbonell, MD annemarie.carbonell@microvention.com

Locations
United States, Arizona
Barrow Neurological Institute Not yet recruiting
Phoenix, Arizona, United States, 85013
Principal Investigator: Cameron McDougall, 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: February 27, 2013
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 May 16, 2013