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O-035 SAFE (Safety and Efficacy Analysis of Fred Embolic Device in Aneurysm Treatment): Study Design and Preliminary Results
  1. L Pierot,
  2. J Gauvrit,
  3. J Lejeune,
  4. A Derelle,
  5. J Gabrillargues
  1. Radiology, Hôpital Maison-Blanche, Reims, France

Abstract

Purpose Flow diversion is now a well-established endovascular technique for the treatment of intracranial aneurysms. FRED and FRED Jr are dual-layer, self-expanding nickel titanium flow-diverters. SAFE is a prospective, multicenter study conducted in 14 French and Belgian centers to evaluate the safety and efficacy of these devices.

Materials and methods Only aneurysms located in the anterior circulation were included. The primary efficacy endpoint is the rate of complete aneurysm occlusion at 6 months without associated stenosis of the parent vessel. The primary safety endpoint is the rate of morbidity (mRS > 2) and mortality at 6 months. Adverse events as well as anatomical results will be independently evaluated. According to the endpoints, the target population is 85 patients, now extended to 95/100.

Results Inclusions started in July 2014. End of February 2016, 92 patients with 92 aneurysms were included. The expectation is to have inclusions completed end of April 2016. Most patients were females (80/92, 87.0%). All but one patient were mRS 0 or 1 before the treatment.

Among the 92 aneurysms, 22 (23.9%) were aneurysm remnant after a previous treatment and the 70 others (76.1%) were unruptured. Aneurysm locations were internal carotid artery (n = 83, 90.2%), anterior communicating artery (n = 6, 6.5%), and middle cerebral artery (n = 3, 3.3%). Aneurysm size was <10 mm in 57 aneurysms (62.0%), 10 to 24 mm in 31 aneurysms (33.7%), and >24 mm in 3 aneurysms (3.3%).

Neck size was <4 mm in 24/91 aneurysms (26.4%) and > or = 4 mm in 67/91 aneurysms (73.6%).

Placement of the flow diverter was achieved in all cases. Intra-operative events were reported in 7/92 patients (7.6%), including technical problems (n = 3), thromboembolic events (n = 3), and others (n = 1). Postoperative events, morbidity, and mortality are also analyzed. Preliminary anatomical results (at 6 months) are presented.

Conclusion SAFE is an ongoing GCP (Good Clinical Practice) study aiming to evaluate safety and efficacy of FRED flow diverter in aneurysm treatment. Inclusions are close from completion. As of now, the safety of the FRED as evaluated by the CEC seems to be in line with published results for Flow Diversion technique.

Disclosures L. Pierot: 2; C; Microvention. J. Gauvrit: 2; C; Microvention. J. Lejeune: 2; C; Microvention. A. Derelle: 2; C; Microvention. J. Gabrillargues: 2; C; Microvention.

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work noncommercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

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