{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,15]],"date-time":"2026-10-15T09:56:31Z","timestamp":1792058191188,"version":"4.4.0"},"reference-count":12,"publisher":"BMJ","issue":"8","funder":[{"DOI":"10.13039\/100008894","name":"Stryker","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100008894","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["J NeuroIntervent Surg"],"accepted":{"date-parts":[[2018,12,12]]},"published-print":{"date-parts":[[2019,8]]},"abstract":"<jats:sec><jats:title>Background and objective<\/jats:title><jats:p>Stent-assisted coil embolization is a well-established treatment of intracranial wide-necked aneurysms. The Neuroform Atlas Stent System is a new generation microstent designed to enhance coil support, conformability, deliverability, and improve deployment accuracy. We present the 1-year efficacy and angiographic results of the Humanitarian Device Exemption (HDE) cohort from the Atlas Investigational Device Exemption (IDE) clinical trial.<\/jats:p><\/jats:sec><jats:sec><jats:title>Method<\/jats:title><jats:p>The Atlas IDE trial is a prospective, multicenter, single-arm, open-label study of unruptured wide-necked intracranial aneurysms treated with the Neuroform Atlas stent and approved coils. The primary efficacy endpoint was the rate of 12-month complete aneurysm angiographic occlusion (Raymond class I) without target aneurysm retreatment or significant parent artery stenosis (&gt;50%) at the target location. The primary safety endpoint was the rate of major ipsilateral stroke or neurological death within 12 months. Imaging core laboratory and Clinical EventsCommittee adjudicated the primary endpoints.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>30 patients were enrolled at eight US centers, with 27 patients completing the 12-month angiographic follow-up. The mean age was 59.4\u00b111.8 years and 24\/30 patients (80%) were women. The mean aneurysm size was 5.3\u00b11.7\u2009mm and the dome:neck ratio was 1.1\u00b10.2. Procedural technical success of Neuroform Atlas Stent deployment was 100%. 27 patients completed 12-month angiographic follow-up and 30 patients completed their 6-month follow-up. When applying the last observation carried forward method, the primary efficacy endpoint was observed in 26\/30 patients (86.7%, 95%\u2009CI 69.3% to 96.2%) compared with 25\/27 patients (92.6%, 95%\u2009CI 75.7% to 99.1%) who completed the 12-month angiographic follow-up. The primary safety endpoint of stroke occurred in one patient (3.3%), who made a complete clinical recovery at discharge. There were no neurological deaths.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>The Neuroform Atlas stent in conjunction with coils demonstrated a high rate of complete aneurysm occlusion at 12-month angiographic follow-up, with an improved safety profile in the HDE cohort.<\/jats:p><\/jats:sec><jats:sec><jats:title>Clinical trial.gov registration number<\/jats:title><jats:p><jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" xlink:href=\"NCT0234058\" ext-link-type=\"clintrialgov\" specific-use=\"clinicaltrial results\">NCT0234058<\/jats:ext-link>;Results<\/jats:p><\/jats:sec>","DOI":"10.1136\/neurintsurg-2018-014455","type":"journal-article","created":{"date-parts":[[2019,1,22]],"date-time":"2019-01-22T23:19:10Z","timestamp":1548199150000},"page":"801-806","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":83,"title":["Neuroform Atlas Stent System for the treatment of intracranial aneurysm: primary results of the Atlas Humanitarian Device Exemption cohort"],"prefix":"10.1136","volume":"11","clinical-trial-number":[{"clinical-trial-number":"nct0234058","registry":"10.18810\/clinical-trials-gov","type":"preResults"},{"clinical-trial-number":"nct0234058","registry":"10.18810\/clinical-trials-gov","type":"results"}],"author":[{"given":"Brian T","family":"Jankowitz","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ricardo","family":"Hanel","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ashutosh P","family":"Jadhav","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David N","family":"Loy","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Donald","family":"Frei","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9519-0059","authenticated-orcid":false,"given":"Adnan H","family":"Siddiqui","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ajit S","family":"Puri","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ahmad","family":"Khaldi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Aquilla S","family":"Turk","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Adel M","family":"Malek","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eric","family":"Sauvageau","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Steven W","family":"Hetts","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4881-4698","authenticated-orcid":false,"given":"Osama O","family":"Zaidat","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"239","published-online":{"date-parts":[[2019,1,22]]},"reference":[{"key":"2024052304411082000_11.8.801.1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jocn.2016.01.035"},{"key":"2024052304411082000_11.8.801.2","doi-asserted-by":"publisher","DOI":"10.1136\/neurintsurg-2014-011457"},{"key":"2024052304411082000_11.8.801.3","doi-asserted-by":"publisher","DOI":"10.1161\/STROKEAHA.111.000641"},{"key":"2024052304411082000_11.8.801.4","first-page":"1","article-title":"Initial clinical experience with a new self-expanding nitinol microstent for the treatment of wide-neck intracranial cerebral aneurysms: the Acandis Acclino Stent","volume":"8","author":"Kabbasch","year":"2015","journal-title":"J Vasc Interv Neurol"},{"key":"2024052304411082000_11.8.801.5","unstructured":"Food and Drug Administration. H020002 - Summary of Safety and Probable Benefit. Neuroform Microdelivery Stent System. 2002. http:\/\/www.accessdata.fda.gov\/cdrh_docs\/pdf2\/H020002B.pdf"},{"key":"2024052304411082000_11.8.801.6","doi-asserted-by":"publisher","DOI":"10.1161\/01.STR.0000073841.88563.E9"},{"key":"2024052304411082000_11.8.801.7","doi-asserted-by":"publisher","DOI":"10.1161\/hs0901.095600"},{"key":"2024052304411082000_11.8.801.8","doi-asserted-by":"publisher","DOI":"10.1136\/neurintsurg-2015-011937"},{"key":"2024052304411082000_11.8.801.9","doi-asserted-by":"publisher","DOI":"10.1159\/000487545"},{"key":"2024052304411082000_11.8.801.10","doi-asserted-by":"publisher","DOI":"10.1136\/neurintsurg-2016-012611"},{"key":"2024052304411082000_11.8.801.11","doi-asserted-by":"crossref","first-page":"263","DOI":"10.1177\/1591019917753710","article-title":"Stent-assisted coiling of cerebral aneurysms with the Neuroform Atlas stent","volume":"24","author":"Cay","year":"2018","journal-title":"Interv Neuroradiol"},{"key":"2024052304411082000_11.8.801.12","doi-asserted-by":"publisher","DOI":"10.3174\/ajnr.A3755"}],"container-title":["Journal of NeuroInterventional Surgery"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/syndication.highwire.org\/content\/doi\/10.1136\/neurintsurg-2018-014455","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,5,23]],"date-time":"2024-05-23T12:13:53Z","timestamp":1716466433000},"score":1,"resource":{"primary":{"URL":"https:\/\/jnis.bmj.com\/lookup\/doi\/10.1136\/neurintsurg-2018-014455"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2019,1,22]]},"references-count":12,"journal-issue":{"issue":"8","published-online":{"date-parts":[[2019,7,11]]},"published-print":{"date-parts":[[2019,8]]}},"alternative-id":["10.1136\/neurintsurg-2018-014455"],"URL":"https:\/\/doi.org\/10.1136\/neurintsurg-2018-014455","relation":{},"ISSN":["1759-8478","1759-8486"],"issn-type":[{"value":"1759-8478","type":"print"},{"value":"1759-8486","type":"electronic"}],"subject":[],"published":{"date-parts":[[2019,1,22]]}}}