You are here

  • Home
  • Archive
  • Volume 11, Issue 2
  • SAFE study (Safety and efficacy Analysis of FRED Embolic device in aneurysm treatment): 1-year clinical and anatomical results

Article Text

Article menu

Download PDFPDF

New Devices
Case series
SAFE study (Safety and efficacy Analysis of FRED Embolic device in aneurysm treatment): 1-year clinical and anatomical results
  1. Laurent Pierot1,
  2. Laurent Spelle2,
  3. Jérôme Berge3,
  4. Anne-Christine Januel4,
  5. Denis Herbreteau5,
  6. Mohamed Aggour6,
  7. Michel Piotin7,
  8. Alessandra Biondi8,
  9. Xavier Barreau3,
  10. Charbel Mounayer9,
  11. Chrisanthi Papagiannaki10,
  12. Jean-Paul Lejeune11,
  13. Jean-Yves Gauvrit12,
  14. Anne-Laure Derelle13,
  15. Emmanuel Chabert14,
  16. Vincent Costalat15
  1. 1 Hôpital Maison-Blanche, Université Reims-Champagne-Ardenne, Reims, France
  2. 2 Paris-Saclay University, Hôpital Bicêtre, Assistance Publique-Hôpitaux de Paris, Paris, France
  3. 3 CHU Pellegrin, Bordeaux, France
  4. 4 CHU Toulouse, Toulouse, France
  5. 5 Hôpital Bretonneau, Université François Rabelais, Tours, France
  6. 6 CHU Saint-Etienne, Saint-Etienne, France
  7. 7 Fondation Ophtalmologique A. de Rothschild, Paris, France
  8. 8 Hôpital Jean-Minjoz, CHRU de Besançon, Besançon, France
  9. 9 CHU Dupuytren, Limoges, France
  10. 10 Hôpital Charles Nicolle, Université de Rouen, Rouen, France
  11. 11 CHU Lille, Lille, France
  12. 12 CHU Rennes, Rennes, France
  13. 13 CHU Nancy, Nancy, France
  14. 14 CHU Clermont-Ferrand, Clermont-Ferrand, France
  15. 15 Hôpital Gui de Chauliac, Université de Montpellier, Montpellier, France
  1. Correspondence to Dr Laurent Pierot, Department of Neuroradiology, Hôpital Maison-Blanche, Reims cedex 51092, France; lpierot{at}gmail.com

Abstract

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.

  • aneurysm
  • flow diverter

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 non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

https://doi.org/10.1136/neurintsurg-2018-014261

Statistics from Altmetric.com

    Request Permissions

    If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.

    View Full Text

    Footnotes

    • 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; drafted the work or revised it for significant intellectual content; approved the final version of the manuscript; agree to be accountable for all aspects of the work, including its accuracy and integrity.

    • Funding The SAFE study was funded by MicroVention Europe.

    • Competing interests LP is a consultant for Balt, Microvention, Neuravi, and Penumbra. LS is a consultant for Balt, Medtronic, Microvention, and Stryker. DH is a consultant for Codman, Medtronic, Sequent, and Stryker. MP is a consultant for Balt, Medtronic, Microvention, and Stryker. AB is a consultant for Balt, Medtronic, Microvention, Stryker, and Phenox. XB is a consultant for Microvention, Sequent, and Stryker. VC is a consultant for Microvention and Balt and receives educational grants from Medtronic and Stryker.

    • Patient consent Obtained.

    • Provenance and peer review Not commissioned; externally peer reviewed.