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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.
February 26, 2013
February 28, 2013
August 31, 2017
July 2013
December 2017   (Final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01801007 on ClinicalTrials.gov Archive Site
Incidence of FRED system and procedure related serious adverse events [ Time Frame: 12 months ]
Same as current
Proportion of subjects with complete occlusion of the target aneurysm and ≤50% stenosis of the parent artery [ Time Frame: 12 months ]
Same as current
 
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
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.
Not Provided
Interventional
Phase 3
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Intracranial Aneurysms
Device: Flow Re-Direction Endoluminal Device
Flow Re-Direction Endoluminal Device
Intervention: Device: Flow Re-Direction Endoluminal Device
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
195
December 2017
December 2017   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
22 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01801007
CL12001
G120111 ( Other Identifier: FDA )
Yes
Not Provided
Not Provided
Microvention-Terumo, Inc.
Microvention-Terumo, Inc.
Not Provided
Principal Investigator: Cameron McDougall, MD
Microvention-Terumo, Inc.
August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP