Safety and Efficacy Analysis of FRED® Embolic Device in Aneurysm Treatment (SAFE)
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ClinicalTrials.gov Identifier: NCT02921698 |
Recruitment Status :
Completed
First Posted : October 3, 2016
Last Update Posted : May 17, 2018
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Condition or disease | Intervention/treatment |
---|---|
Intracranial Aneurysms | Device: FRED® |
Study Type : | Observational [Patient Registry] |
Actual Enrollment : | 100 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Target Follow-Up Duration: | 12 Months |
Official Title: | Safety and Efficacy Analysis of FRED® Embolic Device in Aneurysm Treatment |
Study Start Date : | July 2014 |
Actual Primary Completion Date : | February 2017 |
Actual Study Completion Date : | December 2017 |

Group/Cohort | Intervention/treatment |
---|---|
FRED® |
Device: FRED®
Flow Re-Direction Endoluminal Device |
- Aneurysm occlusion without ˃ 50% parent artery stenosis [ Time Frame: 6 months ]
- Morbidity rate [ Time Frame: 6 months ]
- Mortality rate [ Time Frame: 6 months ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Patient is aged ≥18 years
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Patient has an unruptured or recanalized intracranial aneurysm :
- for which an endovascular treatment has been determined appropriate
- that can not be treated by standard techniques (coiling with or without remodeling)
- and for which the FRED® Flow Diverter has been determined an appropriate treatment
- Patient or patient's legally authorized representative has been informed about the confidentiality of the study and agrees to the collection of his/her personal data
- Patient presents with an mRS score between 0 and 2
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Patients who have already been treated with a stent or a flow diverter for another aneurysm may be included if:
- the previous treatment was more than three months prior to enrollment in this study
- the aneurysm to be treated for this study is a new aneurysm located on a different parent vessel unless the stent already in place is implanted on the proximal carotid artery.
Exclusion Criteria:
- Patient has a known allergy to antiplatelet therapy, heparin and/or contrast medium
- Patient has contraindication to antiplatelet therapy and/or heparin
- Patient is pregnant and/or breastfeeding
- Patient may not benefit from imaging and clinical monitoring
- Patient has a medical or surgical co-morbidities limiting his/her life expectancy to less than 1 year
- Patient will be treated with a flow diverter other than FRED®
- Patient had an intracranial hemorrhage within the 30 days preceding treatment
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Patient has an aneurysm(s) with one or more of the following characteristics:
- associated with an arteriovenous malformation
- dissecting or ""blister-like""
- multiple (unless only one aneurysm requires treatment)
- located in the posterior circulation
- treated with a stent or a flow diverter on the same parent vessel (excluding proximal carotid artery) or in the 3 months prior to inclusion
- Patient has stenosis of the aneurysm parent artery.

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): NCT02921698
Principal Investigator: | Laurent Pierot, Prof. | CHU Reims; Reims, France |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Microvention-Terumo, Inc. |
ClinicalTrials.gov Identifier: | NCT02921698 |
Other Study ID Numbers: |
SAFE |
First Posted: | October 3, 2016 Key Record Dates |
Last Update Posted: | May 17, 2018 |
Last Verified: | August 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Intracranial Aneurysm Aneurysm Vascular Diseases Cardiovascular Diseases Intracranial Arterial Diseases |
Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases |