{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,24]],"date-time":"2026-07-24T05:57:25Z","timestamp":1784872645299,"version":"3.55.0"},"reference-count":26,"publisher":"BMJ","issue":"4","funder":[{"name":"Microvention"}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["J NeuroIntervent Surg"],"accepted":{"date-parts":[[2018,8,17]]},"published-print":{"date-parts":[[2019,4]]},"abstract":"<jats:sec>\n                  <jats:title>Introduction<\/jats:title>\n                  <jats:p>The LVIS stent system (LVIS and LVIS Junior) is a self-expanding, retrievable, microstent system indicated for the treatment of wide-necked cerebral aneurysms (WNAs). The present pivotal study was performed to evaluate the safety and effectiveness of this device.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>The US LVIS pivotal trial was a prospective, multicenter, single-arm, interventional study conducted at 21 US centers. The study enrolled 153 adults with WNAs of the anterior and posterior circulations. The study was conducted under good clinical practices and included independent adjudication of all adverse events. The primary effectiveness endpoint was defined as successful aneurysm treatment with the LVIS System as evidenced by complete (100%) aneurysm occlusion at 12 months on conventional angiography without retreatment and without significant (\u226550%) stenosis of the treated artery at 12 months as determined by an independent core laboratory. The primary safety endpoint was defined as the rate of stroke or death within 30 days, or ipsilateral stroke or neurologic death with 12 months.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>One hundred and fifty-three patients enrolled at 21 investigational sites underwent attempted LVIS-assisted coil embolization. The mean age was 58.3\u00b110.5 years and the majority of the participants (110\/153, 71.9%) were female. Fifty-seven aneurysms (57\/153, 37.3%) arose from the anterior cerebral artery, 43 (43\/153, 28.1%) from the internal carotid artery, 17 (17\/153, 11.1%) from the middle cerebral artery, 27 (27\/153, 17.6%) from the basilar artery, six (6\/153,3.9 %) from the PCA, and two from the vertebral artery. A single aneurysm arose from the superior cerebellar artery. The mean aneurysm dome height was 6.0\u00b12.2\u2009mm and mean width 5.5\u00b12.3\u2009mm. Mean neck width was 4.2\u00b11.4\u2009mm. A total of 22 participants presented for re-treatment of a previously ruptured (&gt;30 days prior to treatment) target aneurysm. The primary effectiveness endpoint was observed in 70.6% (108\/153) in the intent to treat population (ITT). Of the evaluable participants with follow-up 12-month angiography, 79.1 % (110\/139) demonstrated complete occlusion\u2013 92.1% (128\/139) in this population demonstrated \u226595%\u2009occlusion and 95% demonstrated \u226590%\u2009occlusion (132\/139). Eight participants (5.2%, 8\/153) had at least one primary safety event in the ITT population.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusion<\/jats:title>\n                  <jats:p>The LVIS stent system allows safe and highly effective coil embolization of WNAs.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Clinical registration number<\/jats:title>\n                  <jats:p>NCT01793792.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1136\/neurintsurg-2018-014309","type":"journal-article","created":{"date-parts":[[2018,10,8]],"date-time":"2018-10-08T12:32:57Z","timestamp":1539001977000},"page":"357-361","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":59,"title":["The safety and effectiveness of the LVIS stent system for the treatment of wide-necked cerebral aneurysms: final results of the pivotal US LVIS trial"],"prefix":"10.1136","volume":"11","clinical-trial-number":[{"clinical-trial-number":"nct01793792","registry":"10.18810\/clinical-trials-gov"}],"author":[{"given":"David","family":"Fiorella","sequence":"first","affiliation":[{"name":"Department of Neurosurgery, State University of New York at Stony Brook, Stony Brook, New York, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alan","family":"Boulos","sequence":"additional","affiliation":[{"name":"Department of Neurosurgery, Albany Medical College, Albany, New York, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Aquilla S","family":"Turk","sequence":"additional","affiliation":[{"name":"Department of Neurosurgery, Medical University of South Carolina, Charleston, South Carolina, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Adnan H","family":"Siddiqui","sequence":"additional","affiliation":[{"name":"Department of Neurosurgery, University at Buffalo, State University of New York, Buffalo, New York, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Adam S","family":"Arthur","sequence":"additional","affiliation":[{"name":"Department of Neurosurgery, Semmes\u2013Murphey Neurologic and Spine Institute, University of Tennessee, Memphis, Tennessee, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Orlando","family":"Diaz","sequence":"additional","affiliation":[{"name":"Cerebrovascular Center, Departments of Neurosurgery and Radiology, Houston Methodist Hospital, Houston, Texas, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Demetrius K","family":"Lopes","sequence":"additional","affiliation":[{"name":"Department of Neurological Surgery, Rush University Medical Center, Chicago, Illinois, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"239","published-online":{"date-parts":[[2018,10,8]]},"reference":[{"key":"2025092911491357000_11.4.357.1","doi-asserted-by":"crossref","DOI":"10.1136\/neurintsurg-2012-010276","article-title":"The stent anchor technique for distal access through a large or giant aneurysm","volume":"5","author":"Fargen","year":"2013","journal-title":"J Neurointerv Surg"},{"key":"2025092911491357000_11.4.357.2","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(03)13860-3"},{"key":"2025092911491357000_11.4.357.3","doi-asserted-by":"publisher","DOI":"10.1227\/01.NEU.0000219220.25721.B9"},{"key":"2025092911491357000_11.4.357.4","doi-asserted-by":"crossref","first-page":"591","DOI":"10.1136\/jnnp.73.5.591","article-title":"Endovascular coiling versus neurosurgical clipping in patients with a ruptured basilar tip aneurysm","volume":"73","author":"Lusseveld","year":"2002","journal-title":"J of Neurosurg Psychiatry"},{"key":"2025092911491357000_11.4.357.5","doi-asserted-by":"publisher","DOI":"10.3171\/2013.3.JNS12683"},{"key":"2025092911491357000_11.4.357.6","doi-asserted-by":"publisher","DOI":"10.3171\/2014.9.JNS141749"},{"key":"2025092911491357000_11.4.357.7","doi-asserted-by":"publisher","DOI":"10.1136\/neurintsurg-2015-011937"},{"key":"2025092911491357000_11.4.357.8","doi-asserted-by":"publisher","DOI":"10.1136\/neurintsurg-2016-012687"},{"key":"2025092911491357000_11.4.357.9","doi-asserted-by":"publisher","DOI":"10.1136\/neurintsurg-2017-013375"},{"key":"2025092911491357000_11.4.357.10","doi-asserted-by":"crossref","unstructured":"Santillan A , Boddu S , Schwarz J , et al . Stent for treatment of intracranial aneurysms with parent vessel diameter of 2.5 mm or less. 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Wide-neck bifurcation aneurysms of the middle cerebral artery and basilar apex treated by endovascular techniques: a multicentre, core lab adjudicated study evaluating safety and durability of occlusion (BRANCH). 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