ArticleStroke (Hoboken, N.J.)2026
Five-Year Efficacy and Safety of the FRED Flow-Diverting Stent for Intracranial Aneurysms: Results From a Prospective Cohort.
Article in Stroke (Hoboken, N.J.), 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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10 authors.
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Abstract
backgroundFlow diversion is a well-established endovascular treatment for intracranial aneurysms, yet long-term outcome data remain scarce. Our aim was to report efficacy and safety at 5 years for the flow redirection endoluminal device in a consecutive cohort with protocolized follow-up.
methodsAll consecutive patients with intracranial aneurysms treated with a flow redirection endoluminal device between December 2015 and July 2020 at 2 university hospitals were included in a prospective registry. Treatment decisions and procedural protocols were standardized. Clinical and imaging follow-up, including scheduled 3-dimensional rotational digital subtraction angiography, continued through August 2025. The primary end point was complete or near-complete occlusion at 5 years, defined as O'Kelly-Marotta (angiographic grading scale) grades C to D. Ischemic, hemorrhagic, and device-related events were prospectively recorded.
resultsA total of 203 patients (mean age, 54.7 years; 77.3% women) with 236 intracranial aneurysms were analyzed. At 5 years, complete or near-complete occlusion (O'Kelly-Marotta grades C-D) was achieved in 225 aneurysms (95.3%), comprising 203 of 211 (96.2%) in the anterior circulation and 22 of 25 (88.0%) in the posterior circulation. Retreatment was required in 5 aneurysms (2.1%), all treated before 2019. Symptomatic complications occurred in 12 of 203 patients (5.9%): 10 ischemic (4.9%) and 2 hemorrhagic (1.0%); no treatment-related deaths, rebleeding, or delayed rupture occurred. One patient had moderate permanent disability, and one died from a contralateral hypertensive hemorrhage deemed unrelated to the device. Asymptomatic device-related findings occurred in 22 of 236 aneurysms (9.3%).
conclusionsFlow redirection endoluminal device achieved durable aneurysm occlusion with a low rate of clinically relevant complications. These findings support sustained efficacy and safety across diverse aneurysm morphologies and locations.
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