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.
Sponsor:
Information provided by (Responsible Party):
Microvention-Terumo, Inc.
ClinicalTrials.gov Identifier:
NCT01801007
First received: February 26, 2013
Last updated: April 1, 2014
Last verified: April 2014

February 26, 2013
April 1, 2014
July 2013
December 2014   (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 ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]
Same as current
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 ]
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 2
Phase 3
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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.
 
Recruiting
127
April 2015
December 2014   (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
Both
22 Years to 75 Years
No
Contact: Kathy Akagha, MPH 7142478183 kathy.akagha@microvention.com
Contact: Vinny Podichetty, MD 7142478043 vinny.podichetty@microvention.com
United States
 
NCT01801007
CL12001, G120111
Yes
Microvention-Terumo, Inc.
Microvention-Terumo, Inc.
Not Provided
Principal Investigator: Cameron McDougall, MD Barrow Neurological Institute
Microvention-Terumo, Inc.
April 2014

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