TY - JOUR
T1 - Pivotal trial of the Neuroform Atlas stent for treatment of posterior circulation aneurysms
T2 - One-year outcomes
AU - Jankowitz, Brian T.
AU - Jadhav, Ashutosh P.
AU - Gross, Bradley
AU - Jovin, Tudor G.
AU - Alhajeri, Abdulnasser A.
AU - Fraser, Justin F.
AU - Hanel, Ricardo A.
AU - Sauvageau, Eric
AU - Aghaebrahim, Amin
AU - Frei, Donald
AU - Bellon, Richard
AU - Loy, David
AU - Puri, Ajit S.
AU - Malek, Adel M.
AU - Thomas, Ajith
AU - Toth, Gabor
AU - Lopes, Demetrius Klee
AU - Crowley, R. Webster
AU - Arthur, Adam S.
AU - Reavey-Cantwell, John
AU - Lin, Eugene
AU - Siddiqui, Adnan H.
AU - Alexander, Michael J.
AU - Khaldi, Ahmad
AU - Colby, Geoffrey P.
AU - Caplan, Justin M.
AU - Satti, Sudhakar R.
AU - Turk, Aquilla S.
AU - Spiotta, Alejandro M.
AU - Klucznik, Richard
AU - Hallam, Danial K.
AU - Kung, David
AU - Froehler, Michael T.
AU - Callison, R. Charles
AU - Kan, Peter
AU - Hetts, Steven W.
AU - Zaidat, Osama O.
N1 - Publisher Copyright:
© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
PY - 2022/2/1
Y1 - 2022/2/1
N2 - 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.
AB - 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.
KW - aneurysm
KW - coil
KW - stent
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UR - http://www.scopus.com/inward/citedby.url?scp=85102577525&partnerID=8YFLogxK
U2 - 10.1136/neurintsurg-2020-017115
DO - 10.1136/neurintsurg-2020-017115
M3 - Article
C2 - 33722961
AN - SCOPUS:85102577525
SN - 1759-8478
VL - 14
SP - 143
EP - 148
JO - Journal of NeuroInterventional Surgery
JF - Journal of NeuroInterventional Surgery
IS - 2
ER -