TY - JOUR T1 - SAFE study (Safety and efficacy Analysis of FRED Embolic device in aneurysm treatment): 1-year clinical and anatomical results JF - Journal of NeuroInterventional Surgery JO - J NeuroIntervent Surg SP - 184 LP - 189 DO - 10.1136/neurintsurg-2018-014261 VL - 11 IS - 2 AU - Laurent Pierot AU - Laurent Spelle AU - Jérôme Berge AU - Anne-Christine Januel AU - Denis Herbreteau AU - Mohamed Aggour AU - Michel Piotin AU - Alessandra Biondi AU - Xavier Barreau AU - Charbel Mounayer AU - Chrisanthi Papagiannaki AU - Jean-Paul Lejeune AU - Jean-Yves Gauvrit AU - Anne-Laure Derelle AU - Emmanuel Chabert AU - Vincent Costalat Y1 - 2019/02/01 UR - http://jnis.bmj.com/content/11/2/184.abstract N2 - Background and purpose Flow diversion is an innovative and increasingly used endovascular treatment for intracranial aneurysms. Its initial evaluation with the first devices available showed good efficacy of this treatment with variable safety results. The Flow Direction Endoluminal Device (FRED) has a specific design and was evaluated in a single-arm, multicenter, prospective, Good Clinical Practice study: SAFE (Safety and efficacy Analysis of FRED Embolic device in aneurysm treatment). This analysis reports clinical results at 1 year and anatomical results at 6 months and 1 year.Methods Patients with unruptured and recanalized aneurysms located in the anterior circulation treated with FRED and FRED Jr were prospectively included. A Clinical Event Committee and a Core Laboratory independently evaluated clinical outcome and anatomical results.Results Thirteen interventional neuroradiology centers included 103 patients/aneurysms. Aneurysm locations were supraclinoid internal carotid artery (ICA) in 71 (68.9%), cavernous ICA in 15 (14.6%), anterior cerebral or anterior communicating artery in 9 (8.7%), and middle cerebral artery in 8 (7.8%). Most aneurysms were small (<10 mm) in 71 patients (68.9%). Cumulative 1-year mortality and morbidity rates were 2/103 (1.9%) and 3/103 (2.9%), respectively, one death being related to cancer. At 1 year, anatomical results were: complete occlusion in 66/90 patients (73.3%), neck remnant in 7/90 patients (7.8%), and aneurysm remnant in 17/90 patients (18.9%).Conclusions SAFE study analysis at 1 year confirms the excellent safety profile of the FRED device for aneurysm treatment, with low morbidity and mortality rates (2.9% and 1.9%, respectively) and demonstrates its efficacy (adequate occlusion in 73/90 (81.1%)).Clinical trial registration Unique identifier: NCT02921698; Results. ER -