Post-approval study 3-year outcomes of the Neuroform Atlas stent for the treatment of wide-necked intracranial aneurysms

Authors

• Brian Jankowitz, JFK University HospitalFollow
• Ashutosh P. Jadhav, St. Joseph's Hospital and Medical Center
• Bradley Gross, University of Pittsburgh
• Tudor G. Jovin, Cooper University Hospital
• Abdulnasser A. Alhajeri, Riverside Radiology and Interventional Associates Inc
• Justin F. Fraser, University of KentuckyFollow
• Ricardo A. Hanel, Baptist Neurological Institute
• Eric Sauvageau, Baptist Neurological Institute
• Amin Aghaebrahim, Baptist Neurological Institute
• Donald Frei, Radiology Imaging Associates
• Richard Bellon, Radiology Imaging Associates
• David N. Loy, University of Virginia
• Ajit S. Puri, University of Massachusetts System
• Adel M. Malek, New England Medical Center
• Ajith J. Thomas, Cooper University Hospital
• Gabor Toth, CCF
• Demetrius Klee Lopes, Advocate Health
• R. Webster Crowley, Rush University
• John Reavey-Cantwell, Virginia Commonwealth University
• Eugene Lin, Mercy Health Partners
• Adnan Siddiqui, SUNY Buffalo
• Michael J. Alexander, Cedars-Sinai Medical Center
• Ahmad Khaldi, WellStar Health System
• Geoffrey P. Colby, University of California, Los Angeles
• Justin M. Caplan, Johns Hopkins University School of Medicine
• Sudhakar R. Satti, CCHS
• Aquilla S. Turk, Prisma Health
• Alejandro M. Spiotta, Medical University of South Carolina
• Richard Klucznik, Houston Methodist Hospital
• Danial K. Hallam, University of Washington
• David Kung, Division of Neurosurgery
• Michael T. Froehler, Vanderbilt University

Abstract

Introduction The ATLAS trial was a prospective, multicenter, single-arm, investigational device exemption (IDE) study to evaluate the safety and effectiveness of the Neuroform Atlas Stent System for the treatment of widenecked bifurcation aneurysms. This analysis presents the 36-month follow-up data for the anterior and posterior cohorts. Methods Of the 182patients in the IDE anterior cohort, 146 consented to participate in the post-approval study (PAS) and, of the 116patients in the IDE posterior cohort, 101 consented to participate in the PAS. The primary effectiveness endpoint was core laboratory adjudicated (Raymond–Roy 1; RR1) without retreatment or parent artery stenosis (>50%) at 36months post-procedure. The primary safety endpoint was Clinical Event Committeeadjudicated major ipsilateral stroke or neurological death through 36months. Results There were 146patients in the anterior cohort and 101patients in the posterior cohort. At 24months the composite effectiveness endpoint was 77.3% (34/44) in the anterior cohort and 65.5% (19/29) in the posterior cohort and at 36months these rates were 92.3% (24/26) and 75.0% (18/24), respectively. RR1 rates at 24months were 84.1% (37/44) in the anterior cohort and 70.0% (21/30) in the posterior cohort; at 36months they were 96.3% (26/27) and 79.2% (19/24), respectively. By 36months the primary safety endpoint occurred in 4.1% (6/146) of patients in the anterior cohort and 5.0% (5/101) in the posterior cohort. Conclusion The results of the long-term assessment of the Neuroform Atlas Stent System demonstrate favorable safety and effectiveness in the treatment of wide-necked bifurcation aneurysms without a single treated target aneurysm rupture beyond 12months post-procedure.

Document Type

Article

Publication Date

1-1-2026

Notes/Citation Information

Publisher Copyright: © Author(s) (or their employer(s)) 2026. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ Group.

Digital Object Identifier (DOI)

10.1136/jnis-2025-024547

Archival?

Archival

Repository Citation

Jankowitz, Brian; Jadhav, Ashutosh P.; Gross, Bradley; Jovin, Tudor G.; Alhajeri, Abdulnasser A.; Fraser, Justin F.; Hanel, Ricardo A.; Sauvageau, Eric; Aghaebrahim, Amin; Frei, Donald; Bellon, Richard; Loy, David N.; Puri, Ajit S.; Malek, Adel M.; Thomas, Ajith J.; Toth, Gabor; Lopes, Demetrius Klee; Crowley, R. Webster; Reavey-Cantwell, John; Lin, Eugene; Siddiqui, Adnan; Alexander, Michael J.; Khaldi, Ahmad; Colby, Geoffrey P.; Caplan, Justin M.; Satti, Sudhakar R.; Turk, Aquilla S.; Spiotta, Alejandro M.; Klucznik, Richard; Hallam, Danial K.; Kung, David; and Froehler, Michael T., "Post-approval study 3-year outcomes of the Neuroform Atlas stent for the treatment of wide-necked intracranial aneurysms" (2026). Neurology Faculty Publications. 158.
https://uknowledge.uky.edu/neurology_facpub/158