{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,14]],"date-time":"2026-03-14T09:14:28Z","timestamp":1773479668708,"version":"3.50.1"},"reference-count":18,"publisher":"Wiley","issue":"6","license":[{"start":{"date-parts":[[2020,7,23]],"date-time":"2020-07-23T00:00:00Z","timestamp":1595462400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Journal of Neuroimaging"],"published-print":{"date-parts":[[2020,11]]},"abstract":"<jats:title>ABSTRACT<\/jats:title><jats:sec><jats:title>BACKGROUND AND PURPOSE<\/jats:title><jats:p>Due to higher rates of 1\u2010month stroke and death with Wingspan intracranial stent placement observed in SAMMPRIS, the Food and Drug Administration (FDA) announced a more limited indication for Wingspan stent.<\/jats:p><\/jats:sec><jats:sec><jats:title>METHODS<\/jats:title><jats:p>We compared the results of intracranial stent placement with best medical treatment in patients recruited in SAMMPRIS who met the new \u201con label\u201d criteria with those who were categorized as \u201coff label.\u201d The primary endpoint was any stroke or death occurring within 30 days of enrollment, or an ischemic stroke in the territory of the symptomatic intracranial artery from day 31 after study entry to completion of follow\u2010up.<\/jats:p><\/jats:sec><jats:sec><jats:title>RESULTS<\/jats:title><jats:p>A total of 31 (7%) among 451 recruited patients met the \u201con label\u201d criteria. The relative risk of primary endpoint was lower in \u201con label\u201d patients treated with stent placement compared with best medical treatment (relative risk .61, 95% confidence interval .2\u20101.7) but higher in \u201coff label\u201d patients (relative risk 1.81, 95% confidence interval 1.2\u20102.6). Primary endpoint was seen in 20% and 23.4% of patients treated with stent placement in \u201con label\u201d and \u201coff label\u201d patients, respectively. Primary endpoint was seen in 25% and 14.2% of patients treated with best medical treatment in \u201con label\u201d and \u201coff label\u201d patients, respectively.<\/jats:p><\/jats:sec><jats:sec><jats:title>CONCLUSION<\/jats:title><jats:p>The new FDA \u201con label\u201d criteria may identify a small group of people, who may benefit from intracranial stent placement due to higher risk of primary endpoint in those treated with best medical treatment.<\/jats:p><\/jats:sec>","DOI":"10.1111\/jon.12748","type":"journal-article","created":{"date-parts":[[2020,7,24]],"date-time":"2020-07-24T05:56:54Z","timestamp":1595570214000},"page":"857-861","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":6,"title":["The Stenting versus Aggressive Medical Therapy for Intracranial Arterial Stenosis Trial: Reanalysis Using the FDA \u201cOn Label\u201d Criteria"],"prefix":"10.1111","volume":"30","author":[{"given":"Adnan I.","family":"Qureshi","sequence":"first","affiliation":[{"name":"Zeenat Qureshi Stroke Institute  St. Cloud MN"},{"name":"Division of Neurosurgery, Department of Neurology University of Missouri  Columbia MO"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9479-9703","authenticated-orcid":false,"given":"Muhammad F.","family":"Ishfaq","sequence":"additional","affiliation":[{"name":"Zeenat Qureshi Stroke Institute  St. Cloud MN"},{"name":"Department of Neurology University of Tennessee  Memphis TN"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Vamshi K. S.","family":"Balasetti","sequence":"additional","affiliation":[{"name":"Division of Neurosurgery, Department of Neurology University of Missouri  Columbia MO"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5500-6555","authenticated-orcid":false,"given":"Iryna","family":"Lobanova","sequence":"additional","affiliation":[{"name":"Zeenat Qureshi Stroke Institute  St. Cloud MN"},{"name":"Division of Neurosurgery, Department of Neurology University of Missouri  Columbia MO"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Guven","family":"Uzun","sequence":"additional","affiliation":[{"name":"Zeenat Qureshi Stroke Institute  St. Cloud MN"},{"name":"Division of Neurosurgery, Department of Neurology University of Missouri  Columbia MO"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Farhan","family":"Siddiq","sequence":"additional","affiliation":[{"name":"Division of Neurosurgery, Department of Neurology University of Missouri  Columbia MO"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8002-5157","authenticated-orcid":false,"given":"Camilo R.","family":"Gomez","sequence":"additional","affiliation":[{"name":"Division of Neurosurgery, Department of Neurology University of Missouri  Columbia MO"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2020,7,23]]},"reference":[{"key":"e_1_2_5_2_1","unstructured":"Humanitarian Device Exemption (HDE). Available at:https:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfhde\/hde.cfm?id=H050001. Accessed March 05 2020."},{"key":"e_1_2_5_3_1","doi-asserted-by":"publisher","DOI":"10.1161\/STROKEAHA.106.477711"},{"key":"e_1_2_5_4_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1105335"},{"key":"e_1_2_5_5_1","unstructured":"FDA revises indications for use of Stryker's Wingspan stent system. Available at:https:\/\/evtoday.com\/2012\/08\/08\/fda-revises-indications-for-use-of-strykers-wingspan-stent-system?center=126. Accessed March 05 2020."},{"key":"e_1_2_5_6_1","doi-asserted-by":"publisher","DOI":"10.1161\/STROKEAHA.118.023996"},{"key":"e_1_2_5_7_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jstrokecerebrovasdis.2011.05.001"},{"key":"e_1_2_5_8_1","unstructured":"Administration FaD.WEAVE trial postmarket surveillance study. Available at:https:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfPMA\/pss.cfm?t_id=297&c_id=762. 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