Format

Send to

Choose Destination
J Neurointerv Surg. 2019 Feb;11(2):184-189. doi: 10.1136/neurintsurg-2018-014261. Epub 2018 Oct 8.

SAFE study (Safety and efficacy Analysis of FRED Embolic device in aneurysm treatment): 1-year clinical and anatomical results.

Author information

1
Hôpital Maison-Blanche, Université Reims-Champagne-Ardenne, Reims, France.
2
Paris-Saclay University, Hôpital Bicêtre, Assistance Publique-Hôpitaux de Paris, Paris, France.
3
CHU Pellegrin, Bordeaux, France.
4
CHU Toulouse, Toulouse, France.
5
Hôpital Bretonneau, Université François Rabelais, Tours, France.
6
CHU Saint-Etienne, Saint-Etienne, France.
7
Fondation Ophtalmologique A. de Rothschild, Paris, France.
8
Hôpital Jean-Minjoz, CHRU de Besançon, Besançon, France.
9
CHU Dupuytren, Limoges, France.
10
Hôpital Charles Nicolle, Université de Rouen, Rouen, France.
11
CHU Lille, Lille, France.
12
CHU Rennes, Rennes, France.
13
CHU Nancy, Nancy, France.
14
CHU Clermont-Ferrand, Clermont-Ferrand, France.
15
Hôpital Gui de Chauliac, Université de Montpellier, Montpellier, France.

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.

KEYWORDS:

aneurysm; flow diverter

PMID:
30297539
DOI:
10.1136/neurintsurg-2018-014261
[Indexed for MEDLINE]

Conflict of interest statement

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.

Supplemental Content

Full text links

Icon for HighWire
Loading ...
Support Center