Safety and efficacy results of the Flow Redirection Endoluminal Device (FRED) stent system in the treatment of intracranial aneurysms: US pivotal trial

Cameron G. McDougall, Orlando Diaz, Alan Boulos, Adnan H. Siddiqui, Justin Caplan, Johanna T. Fifi, Aquilla S. Turk, Yasha Kayan, Pascal Jabbour, Louis J. Kim, Steven W. Hetts, Daniel L. Cooke, Christopher F. Dowd

Research output: Contribution to journalArticlepeer-review

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.

Original languageEnglish (US)
Pages (from-to)577-584
Number of pages8
JournalJournal of neurointerventional surgery
Volume14
Issue number6
DOIs
StatePublished - 2022

Keywords

  • Aneurysm
  • Flow diverter
  • Intervention
  • Technology

ASJC Scopus subject areas

  • Surgery
  • Clinical Neurology

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