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

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ClinicalTrials.gov Identifier: NCT01801007
Recruitment Status : Active, not recruiting
First Posted : February 28, 2013
Last Update Posted : August 31, 2017
Sponsor:
Information provided by (Responsible Party):
Microvention-Terumo, Inc.

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Intracranial Aneurysms Device: Flow Re-Direction Endoluminal Device Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 195 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : July 2013
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

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Arms and Interventions
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Arm Intervention/treatment
Flow Re-Direction Endoluminal Device Device: Flow Re-Direction Endoluminal Device


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Incidence of FRED system and procedure related serious adverse events [ Time Frame: 12 months ]

Other Outcome Measures:
  1. Proportion of subjects with complete occlusion of the target aneurysm and ≤50% stenosis of the parent artery [ Time Frame: 12 months ]

Eligibility Criteria
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Ages Eligible for Study:   22 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01801007


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Sponsors and Collaborators
Microvention-Terumo, Inc.
Investigators
Principal Investigator: Cameron McDougall, MD
More Information
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Responsible Party: Microvention-Terumo, Inc.
ClinicalTrials.gov Identifier: NCT01801007     History of Changes
Other Study ID Numbers: CL12001
G120111 ( Other Identifier: FDA )
First Posted: February 28, 2013    Key Record Dates
Last Update Posted: August 31, 2017
Last Verified: August 2017

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