Safety and Efficacy Analysis of FRED® Embolic Device in Aneurysm Treatment (SAFE)

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ClinicalTrials.gov Identifier: NCT02921698

Recruitment Status : Completed

First Posted : October 3, 2016

Last Update Posted : May 17, 2018

View this study on Beta.ClinicalTrials.gov

Sponsor:

Information provided by (Responsible Party):

Microvention-Terumo, Inc.

No Study Results Posted on ClinicalTrials.gov for this Study

About Study Results Reporting on ClinicalTrials.gov

Recruitment Status :	Completed
Actual Primary Completion Date :	February 2017
Actual Study Completion Date :	December 2017

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Pierot L, Spelle L, Berge J, Januel AC, Herbreteau D, Aggour M, Piotin M, Biondi A, Barreau X, Mounayer C, Papagiannaki C, Lejeune JP, Gauvrit JY, Derelle AL, Chabert E, Costalat V. SAFE study (Safety and efficacy Analysis of FRED Embolic device in aneurysm treatment): 1-year clinical and anatomical results. J Neurointerv Surg. 2019 Feb;11(2):184-189. doi: 10.1136/neurintsurg-2018-014261. Epub 2018 Oct 8.

Pierot L, Spelle L, Berge J, Januel AC, Herbreteau D, Aggour M, Piotin M, Biondi A, Barreau X, Mounayer C, Papagiannaki C, Lejeune JP, Gauvrit JY, Costalat V. Feasibility, complications, morbidity, and mortality results at 6 months for aneurysm treatment with the Flow Re-Direction Endoluminal Device: report of SAFE study. J Neurointerv Surg. 2018 Aug;10(8):765-770. doi: 10.1136/neurintsurg-2017-013559. Epub 2018 Jan 19.

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