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

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Microvention-Terumo, Inc.

ClinicalTrials.gov Identifier:

NCT01801007

First received: February 26, 2013

Last updated: December 17, 2015

Last verified: December 2015

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:

MedlinePlus related topics: Aneurysms Brain Aneurysm

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 ]


Enrollment:	137
Study Start Date:	July 2013
Estimated Study Completion Date:	August 2017
Estimated Primary Completion Date:	July 2017 (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 (Adult, Senior)
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

Show 22 Study Locations

Sponsors and Collaborators

Microvention-Terumo, Inc.

Investigators


Principal Investigator:	Cameron McDougall, MD	Barrow Neurological Institute

More Information


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:	December 17, 2015
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 September 23, 2016

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