{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,9]],"date-time":"2026-10-09T06:02:01Z","timestamp":1791525721008,"version":"4.3.4"},"reference-count":21,"publisher":"BMJ","issue":"2","funder":[{"name":"Microvention"}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["J NeuroIntervent Surg"],"accepted":{"date-parts":[[2018,8,9]]},"published-print":{"date-parts":[[2019,2]]},"abstract":"<jats:sec>\n                    <jats:title>Background and purpose<\/jats:title>\n                    <jats:p>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\u2009year and anatomical results at 6 months and 1\u2009year.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>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 (&lt;10\u2009mm) 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\u2009year, 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%).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>SAFE study analysis at 1\u2009year 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%)).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Clinical trial registration<\/jats:title>\n                    <jats:p>\n                      Unique identifier:\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" xlink:href=\"NCT02921698\" ext-link-type=\"clintrialgov\" specific-use=\"clinicaltrial results\">NCT02921698<\/jats:ext-link>\n                      ; Results.\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/neurintsurg-2018-014261","type":"journal-article","created":{"date-parts":[[2018,10,8]],"date-time":"2018-10-08T12:30:29Z","timestamp":1539001829000},"page":"184-189","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":128,"title":["SAFE study (Safety and efficacy Analysis of FRED Embolic device in aneurysm treatment): 1-year clinical and anatomical results"],"prefix":"10.1136","volume":"11","clinical-trial-number":[{"clinical-trial-number":"nct02921698","registry":"10.18810\/clinical-trials-gov","type":"results"}],"author":[{"given":"Laurent","family":"Pierot","sequence":"first","affiliation":[{"name":"H\u00f4pital Maison-Blanche, Universit\u00e9 Reims-Champagne-Ardenne, Reims, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Laurent","family":"Spelle","sequence":"additional","affiliation":[{"name":"Paris-Saclay University, H\u00f4pital Bic\u00eatre, Assistance Publique-H\u00f4pitaux de Paris, Paris, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"J\u00e9r\u00f4me","family":"Berge","sequence":"additional","affiliation":[{"name":"CHU Pellegrin, Bordeaux, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anne-Christine","family":"Januel","sequence":"additional","affiliation":[{"name":"CHU Toulouse, Toulouse, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Denis","family":"Herbreteau","sequence":"additional","affiliation":[{"name":"H\u00f4pital Bretonneau, Universit\u00e9 Fran\u00e7ois Rabelais, Tours, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mohamed","family":"Aggour","sequence":"additional","affiliation":[{"name":"CHU Saint-Etienne, Saint-Etienne, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michel","family":"Piotin","sequence":"additional","affiliation":[{"name":"Fondation Ophtalmologique A. de Rothschild, Paris, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alessandra","family":"Biondi","sequence":"additional","affiliation":[{"name":"H\u00f4pital Jean-Minjoz, CHRU de Besan\u00e7on, Besan\u00e7on, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4932-1484","authenticated-orcid":false,"given":"Xavier","family":"Barreau","sequence":"additional","affiliation":[{"name":"CHU Pellegrin, Bordeaux, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Charbel","family":"Mounayer","sequence":"additional","affiliation":[{"name":"CHU Dupuytren, Limoges, 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France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vincent","family":"Costalat","sequence":"additional","affiliation":[{"name":"H\u00f4pital Gui de Chauliac, Universit\u00e9 de Montpellier, Montpellier, France"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"239","published-online":{"date-parts":[[2018,10,8]]},"reference":[{"key":"2025092912411317000_11.2.184.1","doi-asserted-by":"publisher","DOI":"10.1016\/j.neurad.2010.12.002"},{"key":"2025092912411317000_11.2.184.2","doi-asserted-by":"publisher","DOI":"10.1161\/STROKEAHA.113.000733"},{"key":"2025092912411317000_11.2.184.3","doi-asserted-by":"crossref","first-page":"1002","DOI":"10.1001\/jamaneurol.2016.0609","article-title":"Flow diversion for the treatment of intracranial aneurysms","volume":"73","author":"Walcott","year":"2016","journal-title":"JAMA 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