Post-approval study 3-year outcomes of the Neuroform Atlas stent for the treatment of wide-necked intracranial aneurysms
Year: 2026
Type: article
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 wide-necked bifurcation aneurysms. This analysis presents the 36-month follow-up data for the anterior and posterior cohorts. METHODS: Of the 182 patients in the IDE anterior cohort, 146 consented to participate in the post-approval study (PAS) and, of the 116 patients 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 36 months post-procedure. The primary safety endpoint was Clinical Event Committee-adjudicated major ipsilateral stroke or neurological death through 36 months. RESULTS: There were 146 patients in the anterior cohort and 101 patients in the posterior cohort. At 24 months the composite effectiveness endpoint was 77.3% (34/44) in the anterior cohort and 65.5% (19/29) in the posterior cohort and at 36 months these rates were 92.3% (24/26) and 75.0% (18/24), respectively. RR1 rates at 24 months were 84.1% (37/44) in the anterior cohort and 70.0% (21/30) in the posterior cohort; at 36 months they were 96.3% (26/27) and 79.2% (19/24), respectively. By 36 months 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 12 months post-procedure.
Authors: Brian 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 N Loy, Ajit S Puri, Adel M Malek, Ajith J Thomas, Gabor Toth, Demetrius Klee Lopes, R Webster Crowley, John Reavey-Cantwell, Eugene Lin, Adnan 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, Lori Lyn Price, Osama O Zaidat
Institutions: John F. Kennedy Medical Center, Barrow Neurological Institute, University of Pittsburgh, Cooper University Hospital, University of Kentucky, Baptist Medical Center Jacksonville, University of Virginia, University of Massachusetts Chan Medical School, Tufts Medical Center, Rush University, Virginia Commonwealth University, Virginia Commonwealth University Medical Center, Mercy St. Vincent Medical Center, Bon Secours Mercy Health, University at Buffalo, State University of New York, Cedars-Sinai Medical Center, WellStar Health System, University of California, Los Angeles, Johns Hopkins University, Johns Hopkins Medicine, Prisma Health, Medical University of South Carolina, Houston Methodist, University of Washington, Dartmouth–Hitchcock Medical Center, Vanderbilt University Medical Center, The University of Texas Medical Branch at Galveston, University of California, San Francisco, Stryker (United States)
Language: English
Subfield: Neurology
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
OpenAlex ID: W7126217521