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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Intracranial Aneurysms | Device: Flow Re-Direction Endoluminal Device | Phase 3 |
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 |
Arm | Intervention/treatment |
---|---|
Flow Re-Direction Endoluminal Device | Device: Flow Re-Direction Endoluminal Device |
- 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 ]
- Incidence of FRED system and procedure related serious adverse events [ Time Frame: 12 months ]
- Proportion of subjects with complete occlusion of the target aneurysm and ≤50% stenosis of the parent artery [ Time Frame: 12 months ]

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Ages Eligible for Study: | 22 Years to 75 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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

Principal Investigator: | Cameron McDougall, MD |
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 |