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

Brian Jankowitz, Department of Neurosurgery, JFK Health System, Edison, New Jersey, USA Bjankowitz@gmail.com.
Ashutosh P. Jadhav, Department of Neurosurgery, Barrow Neurological Institute, Phoenix, Arizona, USA.
Bradley Gross, Department of Neurosurgery, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.
Tudor G. Jovin, Department of Neurology, Cooper University Hospital, Camden, New Jersey, USA.
Abdulnasser A. Alhajeri, Department of Diagnostic Radiology, Riverside Radiology and Interventional Associates Inc, Columbus, Ohio, USA.
Justin F. Fraser, Department of Neurological Surgery, University of Kentucky, Lexington, Kentucky, USA.
Ricardo A. Hanel, Lyerly Neurosurgery, Baptist Neurological Institute, Jacksonville, Florida, USA.
Eric Sauvageau, Lyerly Neurosurgery, Baptist Neurological Institute, Jacksonville, Florida, USA.
Amin Aghaebrahim, Lyerly Neurosurgery, Baptist Neurological Institute, Jacksonville, Florida, USA.
Donald Frei, Department of Interventional Neuroradiology, Radiology Imaging Associates, Englewood, Colorado, USA.
Richard Bellon, Department of Interventional Neuroradiology, Radiology Imaging Associates, Englewood, Colorado, USA.
David N. Loy, Department of Radiology and Medical Imaging, University of Virginia, Charlottesville, Virginia, USA.
Ajit S. Puri, Department of Radiology, University of Massachusetts, Worcester, Massachusetts, USA.
Adel M. Malek, Department of Neurosurgery, Tufts Medical Center, Boston, Massachusetts, USA.
Ajith J. Thomas, Department of Neurology, Cooper University Hospital, Camden, New Jersey, USA.
Gabor Toth, Cerebrovascular Center, CCF, Cleveland Heights, Ohio, USA.
Demetrius Klee Lopes, Advocate Health - MidwestFollow
et al

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.

Document Type

Article

PubMed ID

41617495

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