@article{53d01908920d4750a44628d7cb7ab898,
title = "Safety and efficacy results of the Flow Redirection Endoluminal Device (FRED) stent system in the treatment of intracranial aneurysms: US pivotal trial",
abstract = "OBJECTIVE: To evaluate the safety and effectiveness of the Flow Redirection Endoluminal Device (FRED) flow diverter in support of an application for Food and Drug Administration approval in the USA.METHODS: 145 patients were enrolled in a prospective, single-arm multicenter trial. Patients with aneurysms of unfavorable morphology for traditional endovascular therapies (large, wide-necked, fusiform, etc) were included. The trial was designed to demonstrate non-inferiority in both safety and effectiveness, comparing trial results with performance goals (PGs) established from peer-reviewed published literature. The primary safety endpoint was death or major stroke (National Institutes of Health Stroke Scale score ≥4 points) within 30 days of the procedure, or any major ipsilateral stroke or neurological death within the first year. The primary effectiveness endpoint was complete occlusion of the target aneurysm with ≤50% stenosis of the parent artery at 12 months after treatment, and in which an alternative treatment of the target intracranial aneurysm had not been performed.RESULTS: 145 patients underwent attempted placement of a FRED device, and one or more devices were placed in all 145 patients. 135/145 (93%) had a single device placed. Core laboratory adjudication deemed 106 (73.1%) of the aneurysms large or giant. A safety endpoint was experienced by 9/145 (6.2%) patients, successfully achieving the safety PG of <15%. The effectiveness PG of >46% aneurysm occlusion was also achieved, with the effectiveness endpoint being met in 80/139 (57.6%) CONCLUSION: As compared with historically derived performance benchmarks, the FRED flow diverter is both safe and effective for the treatment of appropriately selected intracranial aneurysms.CLINICAL REGISTRATION NUMBER: NCT01801007.",
keywords = "Aneurysm, Flow diverter, Intervention, Technology, Prospective Studies, Humans, Stroke/therapy, Treatment Outcome, Intracranial Aneurysm/diagnostic imaging, Endovascular Procedures/methods, Stents, Embolization, Therapeutic/methods",
author = "McDougall, {Cameron G.} and Orlando Diaz and Alan Boulos and Siddiqui, {Adnan H.} and Justin Caplan and Fifi, {Johanna T.} and Turk, {Aquilla S.} and Yasha Kayan and Pascal Jabbour and Kim, {Louis J.} and Hetts, {Steven W.} and Cooke, {Daniel L.} and Dowd, {Christopher F.}",
note = "Funding Information: This work was funded by Microvention-Terumo Inc. Funding Information: Competing interests CGM: consultant to Microvention and Medtronic OOD: proctor for FRED/Microvention. AB: consultant to Microvention and Vesalio. AHS:SNIS Board of Directors; current research grants: co-investigator: NIH/NINDS 1R01NS091075 Virtual intervention of intracranial aneurysms; role: co-principal investigator NIH-NINDS R21 NS109575-01 Optimizing approaches to endovascular therapy of acute ischemic stroke; financial interest: Adona Medical, Inc., Amnis Therapeutics, Bend IT Technologies, Ltd., BlinkTBI, Inc, Boston Scientific Corp (for purchase of Claret Medical), Buffalo Technology Partners, Inc., Cardinal Consultants, LLC, Cerebrotech Medical Systems, Inc, Cognition Medical, Endostream Medical, Ltd, Imperative Care, Inc., Instylla, Inc., International Medical Distribution Partners, IRRAS, LaunchNY Seed Fund Management, LLC, NeuroRadial Technologies, Inc., Neurovascular Diagnostics, Inc., Perflow Medical, Ltd., Q{\textquoteright}Apel Medical, Inc., Radical Catheter Technologies, Inc., Rebound Therapeutics Corp. (purchased 2019 by Integra Lifesciences, Corp), Rist Neurovascular, Inc., Sense Diagnostics, Inc., Serenity Medical, Inc., Silk Road Medical, Spinnaker Medical, Inc., StimMed, Synchron, Three Rivers Medical, Inc., Truvic Medical, Inc, Vastrax, LLC, VICIS, Inc., Viseon, Inc., Viz. ai, Inc; consultant/advisory board: Amnis Therapeutics, Apellis Pharmaceuticals, Inc., Boston Scientific, Canon Medical Systems USA, Inc., Cerebrotech Medical Systems, Inc., Cerenovus, Corindus, Inc., Endostream Medical, Ltd, Imperative Care, Inc., Integra LifeSciences Corp., IRRAS, Medtronic, MicroVention, Minnetronix Neuro, Inc., Northwest University – Data Safety Monitoring Board chair for HEAT Trial, Penumbra, Perflow Medical, Ltd., Q{\textquoteright}Apel Medical, Inc., Rapid Medical, Rebound Therapeutics Corp., Serenity Medical, Inc., Silk Road Medical, StimMed, Stryker, Three Rivers Medical, Inc., VasSol, Viz.ai, Inc., W.L. Gore & Associates; national PI/ steering committees: Cerenovus NAPA Trial and ARISE II Trial; Medtronic SWIFT PRIME and SWIFT DIRECT Trials; MicroVention FRED Trial and CONFIDENCE Study; MUSC POSITIVE Trial; Penumbra 3D Separator Trial, COMPASS Trial, INVEST Trial;• No consulting salary arrangements. All consulting is per project and/or per hour. JC: No disclosures. JTF: SNIS Board of Directors; consultant to Microvention and Stryker. AST: consultant to Microvention, Medtronic, Viz AI, Siemens;.chief medical officer Imperative Care. YK: consultant to Microvention, Penumbra, Medtronic. PJ: consultant to Microvention Funding Information: The US pivotal trial of the FRED Stent System in the Treatment of Intracranial Aneurysms was a prospective, multicenter, single-arm study initiated in 25 US centers and one additional Japanese site. One hundred and forty-five patients were treated at 23 centers with enrollment taking place between July 2013 and December 2016. The last subject visit was in January 2018. The study protocol was approved by each center{\textquoteright}s institutional review board, and all patients submitted written informed consent prior to enrollment. The study was conducted under good clinical practices and included independent adjudication of all adverse events. An independent core laboratory evaluated all angiographic data and adjudicated effectiveness outcomes. An independent Clinical Events Committee (CEC) adjudicated all endpoints. An independent Data Safety Monitoring Board conducted study safety reviews. Funding for this study was provided by Microven-tion Inc. Publisher Copyright: {\textcopyright} 2022 Author(s) (or their employer(s)). Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.",
year = "2022",
doi = "10.1136/neurintsurg-2021-017469",
language = "English (US)",
volume = "14",
pages = "577--584",
journal = "Journal of neurointerventional surgery",
issn = "1759-8478",
publisher = "BMJ Publishing Group",
number = "6",
}