Background and purpose Flow diverters are increasingly used for the treatment of intracranial aneurysms. Evaluation of the first devices available for clinical use showed high efficacy of this treatment although safety results were worse compared with coiling or balloon-assisted coiling. The Safety and Efficacy Analysis of FRED Embolic Device in Aneurysm Treatment (SAFE) trial is a single-arm, multicenter, prospective study conducted to precisely analyze the safety and efficacy of the FRED and FRED Jr devices.
Methods Unruptured and recanalized aneurysms located in the anterior circulation treated with FRED and FRED Jr were prospectively included. Adverse events were independently evaluated by a Clinical Event Committee with a vascular neurosurgeon and an interventional neuroradiologist. Primary safety outcome measures were morbidity and mortality rates at 6 months after treatment.
Results A total of 103 patients/aneurysms were included in 13 interventional neuroradiology (INR) centers. Aneurysm locations were supraclinoid internal carotid artery (ICA) in 71 (68.9%), cavernous ICA in 15 (14.6%), anterior cerebral artery or anterior communicating artery in nine (8.7%), and middle cerebral artery in eight (7.8%). Aneurysms were small (<10 mm) in 71 patients (68.9%). Treatment was successfully performed in 98/103 patients (95.1%). Thromboembolic (TE) complications occurred in 5/103 patients (4.9%), intraoperative rupture in 2/103 patients (1.9%), delayed aneurysm rupture in 1/103 patient (1.0%), and delayed hematoma occurred in 1/103 patient (1.0%). Six-months' mortality and morbidity rates were 1/102 (1.0%) and 2/102 (2.0%), respectively.
Conclusions Aneurysm treatment with the FRED device is safe with low mortality (1.0%) and morbidity (2.0%).
Clinical trial registration NCT02921698.
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Contributors All authors have: provided a substantial contribution to the conception and design of the studies and/or the acquisition and/or the analysis of the data and/or the interpretation of the data. They have drafted the work or revised it for significant intellectual content and approved the final version of the manuscript. They agree to be accountable for all aspects of the work, including its accuracy and integrity.
Funding The SAFE study was funded by Microvention.
Competing interests LP is a consultant for Balt, Microvention, Neuravi, and Penumbra. LS is a consultant for Balt, Medtronic, Microvention, and Stryker. DH is consultant for Codman, Medtronic, Sequent ,and Stryker. MP is consultant for Balt, Medtronic, Microvention, and Stryker. AB is consultant for Balt, Medtronic, Microvention, Stryker, and Phenox. XB is consultant for Microvention, Sequent, and Stryker. VC is consultant for Microvention and Balt and receives educational grants from Medtronic and Stryker.
Ethics approval Reims IRB.
Provenance and peer review Not commissioned; externally peer reviewed.
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