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

Authors

• 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

Publication/Presentation Date

6-1-2022

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.

Volume

14

Issue

6

First Page

577

Last Page

584

ISSN

1759-8486

Published In/Presented At

McDougall, C. G., Diaz, O., Boulos, A., Siddiqui, A. H., Caplan, J., Fifi, J. T., Turk, A. S., Kayan, Y., Jabbour, P., Kim, L. J., Hetts, S. W., Cooke, D. L., & Dowd, C. F. (2022). Safety and efficacy results of the Flow Redirection Endoluminal Device (FRED) stent system in the treatment of intracranial aneurysms: US pivotal trial. Journal of neurointerventional surgery, 14(6), 577–584. https://doi.org/10.1136/neurintsurg-2021-017469

Disciplines

Business Administration, Management, and Operations | Health and Medical Administration | Management Sciences and Quantitative Methods

PubMedID

34282038

Department(s)

Administration and Leadership

Document Type

Article