SAFE: Safety and Efficacy Analysis of FRED® Embolic Device in Aneurysm Treatment
Study Details
Study Description
Brief Summary
A prospective, multicenter, observational evaluation of the safety and efficacy of the FRED® device in the treatment of intracranial aneurysms.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| FRED®
|
Device: FRED®
Flow Re-Direction Endoluminal Device
|
Outcome Measures
Primary Outcome Measures
- Aneurysm occlusion without ˃ 50% parent artery stenosis [6 months]
- Morbidity rate [6 months]
- Mortality rate [6 months]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Patient is aged ≥18 years
-
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
-
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
-
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.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Microvention-Terumo, Inc.
Investigators
- Principal Investigator: Laurent Pierot, Prof., CHU Reims; Reims, France
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SAFE