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-Cantwell; Eugene 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

doi:10.1136/neurintsurg-2020-017115

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

J Neurointerv Surg. 2022 Feb;14(2):143-148. doi: 10.1136/neurintsurg-2020-017115. Epub 2021 Mar 15.

Authors

Brian T Jankowitz¹, Ashutosh P Jadhav², Bradley Gross³, Tudor G Jovin⁴, Abdulnasser A Alhajeri⁵, Justin F Fraser⁶, Ricardo A Hanel⁷, Eric Sauvageau⁸, Amin Aghaebrahim⁹, Donald Frei¹⁰, Richard Bellon¹⁰, David Loy¹¹, Ajit S Puri¹², Adel M Malek¹³, Ajith Thomas¹⁴, Gabor Toth¹⁵, Demetrius Klee Lopes¹⁶, R Webster Crowley¹⁷, Adam S Arthur^{18

19}, John Reavey-Cantwell²⁰, Eugene Lin²¹, Adnan H Siddiqui²², Michael J Alexander²³, Ahmad Khaldi²⁴, Geoffrey P Colby²⁵, Justin M Caplan²⁶, Sudhakar R Satti²⁷, Aquilla S Turk²⁸, Alejandro M Spiotta²⁹, Richard Klucznik³⁰, Danial K Hallam³¹, David Kung³², Michael T Froehler³³, R Charles Callison³⁴, Peter Kan³⁵, Steven W Hetts³⁶, Osama O Zaidat³⁷

Affiliations

¹ Cooper Neurological Institute, Cooper University Hospital, Camden, New Jersey, USA [email protected].
² Barrow Neurological Institute, Phoenix, Arizona, USA.
³ Department of Neurosurgery, University of Pittsburgh Medical Center, Pittsburgh, PA, USA.
⁴ Department of Neurology, Cooper University Hospital, Camden, New Jersey, USA.
⁵ Department of Diagnostic Radiology, Riverside Radiology and Interventional Associates Inc, Columbus, Ohio, USA.
⁶ Department of Neurological Surgery, University of Kentucky, Lexington, Kentucky, USA.
⁷ Baptist Health System Jacksonville, Jacksonville, Florida, USA.
⁸ Lyerly Neurosurgery, Baptist Neurological Institute, Jacksonville, Florida, USA.
⁹ Neurological Institute, Lyerley Neurosurgery, Baptist Medical Center Jacksonville, Jacksonville, Florida, USA.
¹⁰ Department of Interventional Neuroradiology, Radiology Imaging Associates, Englewood, Colorado, USA.
¹¹ Department of Radiology, University of Virginia Medical Center, Charlottesville, Virginia, USA.
¹² Department of Radiology, University of Massachusetts, Worcester, Massachusetts, USA.
¹³ Department of Neurosurgery, Tufts Medical Center, Boston, Massachusetts, USA.
¹⁴ Department of Surgery, Division of Neurosurgery, Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA.
¹⁵ Cerebrovascular Center, Cleveland Clinic, Cleveland, OH, USA.
¹⁶ Brain and Spine Institute, Advocate Aurora Health, Park Ridge, Illinois, USA.
¹⁷ Rush University, Chicago, Illinois, USA.
¹⁸ Semmes-Murphey Neurologic and Spine Institute, Memphis, Tennessee, USA.
¹⁹ Department of Neurosurgery, University of Tennessee Health Science Center, Memphis, Tennessee, USA.
²⁰ Virginia Commonwealth University, Richmond, Virginia, USA.
²¹ Neuroscience Department, Mercy Health St Vincent Medical Center Department of Internal Medicine, Toledo, Ohio, USA.
²² Department of Neurosurgery, University at Buffalo, Buffalo, New York, USA.
²³ Department of Neurosurgery, Cedars-Sinai Medical Center, Los Angeles, California, USA.
²⁴ Department of Neurosurgery, Wellstar Health System, Marietta, Georgia, USA.
²⁵ Department of Neurosurgery, University of California Los Angeles, Los Angeles, California, USA.
²⁶ Department of Neurosurgery, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
²⁷ Department of Neurointerventional Surgery, CCHS, Newark, Delaware, USA.
²⁸ Department of Neuroradiology, Prisma Helath, Greenville, South Carolina, USA.
²⁹ Department of Neurosurgery, Medical University of South Carolina, Charleston, South Carolina, USA.
³⁰ Division of Interventional Neuroradiology, Houston Methodist Hospital, Houston, Texas, USA.
³¹ Department of Radiology, University of Washington, Seattle, Washington, USA.
³² Department of Neurosurgery, University of Pennsylvania, Philadelphia, Pennsylvania, USA.
³³ Cerebrovascular Program, Vanderbilt University, Nashville, Tennessee, USA.
³⁴ Department of Interventional Neurology, Lawnwood Regional Medical Center and Heart Institute, Fort Pierce, Florida, USA.
³⁵ Department of Neurosurgery, Baylor College of Medicine, Houston, Texas, USA.
³⁶ Department of Radiology, UCSF, San Francisco, California, USA.
³⁷ Department of Neuroscience, St Vincent Mercy Hospital, Toledo, Ohio, USA.

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.

Publication types

Multicenter Study

MeSH terms

Aged
Cerebral Angiography
Embolization, Therapeutic*
Female
Humans
Intracranial Aneurysm* / diagnostic imaging
Intracranial Aneurysm* / surgery
Middle Aged
Prospective Studies
Retrospective Studies
Stents
Treatment Outcome

Associated data

ClinicalTrials.gov/NCT02340585