UMMS Affiliation

Department of Radiology

Publication Date

2021-03-15

Document Type

Article

Disciplines

Cardiovascular Diseases | Neurology | Neurosurgery | Radiology

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.

Keywords

aneurysm, coil, stent

Rights and Permissions

© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

DOI of Published Version

10.1136/neurintsurg-2020-017115

Source

Jankowitz BT, Jadhav AP, Gross B, Jovin TG, Alhajeri AA, Fraser JF, Hanel RA, Sauvageau E, Aghaebrahim A, Frei D, Bellon R, Loy D, Puri AS, Malek AM, Thomas A, Toth G, Lopes DK, Crowley RW, Arthur AS, Reavey-Cantwell J, Lin E, Siddiqui AH, Alexander MJ, Khaldi A, Colby GP, Caplan JM, Satti SR, Turk AS, Spiotta AM, Klucznik R, Hallam DK, Kung D, Froehler MT, Callison RC, Kan P, Hetts SW, Zaidat OO. Pivotal trial of the Neuroform Atlas stent for treatment of posterior circulation aneurysms: one-year outcomes. J Neurointerv Surg. 2021 Mar 15:neurintsurg-2020-017115. doi: 10.1136/neurintsurg-2020-017115. Epub ahead of print. PMID: 33722961. Link to article on publisher's site

Journal/Book/Conference Title

Journal of neurointerventional surgery

Comments

Full author list omitted for brevity. For the full list of authors, see article.

Related Resources

Link to Article in PubMed

PubMed ID

33722961

Creative Commons License

Creative Commons Attribution-Noncommercial 4.0 License
This work is licensed under a Creative Commons Attribution-Noncommercial 4.0 License

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