Pivotal trial of the Neuroform Atlas stent for treatment of posterior circulation aneurysms: One-year outcomes

Brian T. Jankowitz, Ashutosh P. Jadhav, Bradley Gross, Tudor G. Jovin, Abdulnasser A. Alhajeri, Justin F. Fraser, Ricardo A. Hanel, Eric Sauvageau, Amin Aghaebrahim, Donald Frei, Richard Bellon, David Loy, Ajit S. Puri, Adel M. Malek, Ajith Thomas, Gabor Toth, Demetrius Klee Lopes, R. Webster Crowley, Adam S. Arthur, John Reavey-CantwellEugene Lin, Adnan H. Siddiqui, Michael J. Alexander, Ahmad Khaldi, Geoffrey P. Colby, Justin M. Caplan, Sudhakar R. Satti, Aquilla S. Turk, Alejandro M. Spiotta, Richard Klucznik, Danial K. Hallam, David Kung, Michael T. Froehler, R. Charles Callison, Peter Kan, Steven W. Hetts, Osama O. Zaidat

Research output: Contribution to journalArticlepeer-review

18 Scopus citations

Abstract

Background Stent-assisted coiling of wide-necked intracranial aneurysms (IAs) using the Neuroform Atlas Stent System (Atlas) has shown promising results. Objective To present the primary efficacy and safety results of the ATLAS Investigational Device Exemption (IDE) trial in a cohort of patients with posterior circulation IAs. Methods The ATLAS trial is a prospective, multicenter, single-arm, open-label study of unruptured, wide-necked, IAs treated with the Atlas stent and adjunctive coiling. This study reports the results of patients with posterior circulation IAs. The primary efficacy endpoint was complete aneurysm occlusion (Raymond-Roy (RR) class I) on 12-month angiography, in the absence of re-treatment or parent artery stenosis >50%. The primary safety endpoint was any major ipsilateral stroke or neurological death within 12 months. Adjudication of the primary endpoints was performed by an imaging core laboratory and a Clinical Events Committee. Results The ATLAS trial enrolled and treated 116 patients at 25 medical centers with unruptured, wide-necked, posterior circulation IAs (mean age 60.2±10.5 years, 81.0% (94/116) female). Stents were placed in all patients with 100% technical success rate. A total of 95/116 (81.9%) patients had complete angiographic follow-up at 12 months, of whom 81 (85.3%) had complete aneurysm occlusion (RR class I). The primary effectiveness outcome was achieved in 76.7% (95% CI 67.0% to 86.5%) of patients. Overall, major ipsilateral stroke and secondary persistent neurological deficit occurred in 4.3% (5/116) and 1.7% (2/116) of patients, respectively. Conclusions In the ATLAS IDE posterior circulation cohort, the Neuroform Atlas Stent System with adjunctive coiling demonstrated high rates of technical and safety performance. Trial registration number https://clinicaltrials.gov/ct2/show/NCT02340585.

Original languageEnglish
Pages (from-to)143-148
Number of pages6
JournalJournal of NeuroInterventional Surgery
Volume14
Issue number2
DOIs
StatePublished - Feb 1 2022

Bibliographical note

Publisher Copyright:
© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Funding

Funding The ATLAS trial (Safety and Effectiveness of the Treatment of Wide Necked, Saccular Intracranial Aneurysms with the Neuroform Atlas Stent System) was funded by Stryker Neurovascular.

FundersFunder number
Cerenovus Incorporated
National Institutes of Health (NIH)
Genentech Incorporated
Medtronic

    Keywords

    • aneurysm
    • coil
    • stent

    ASJC Scopus subject areas

    • Surgery
    • Clinical Neurology

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