{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,22]],"date-time":"2026-10-22T22:57:47Z","timestamp":1792709867795,"version":"4.5.0"},"reference-count":30,"publisher":"SAGE Publications","issue":"6","license":[{"start":{"date-parts":[[2017,6,1]],"date-time":"2017-06-01T00:00:00Z","timestamp":1496275200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["International Journal of Stroke"],"published-print":{"date-parts":[[2017,8]]},"abstract":"<jats:sec>\n                    <jats:title>Rationale<\/jats:title>\n                    <jats:p>Efficacy of mechanical thrombectomy for acute stroke due to large vessel occlusion initiated beyond 6\u2009h of time last seen well has not been demonstrated in randomized trials.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Aim<\/jats:title>\n                    <jats:p>\n                      To establish whether subjects considered to have substantial areas of salvageable brain based on age-adjusted clinical core mismatch who can undergo endovascular treatment within 6\u201324\u2009h from time last seen well (TLSW) have better outcomes at three months compared to subjects treated with standard medical therapy alone. Age-adjusted clinical core mismatch is defined by age (\u226480 or &gt;80 years), baseline National Institutes of Health Stroke Scale (NIHSS) (10\u201320 or \u226521), and core size (0\u201320\u2009cm\n                      <jats:sup>3<\/jats:sup>\n                      in subjects older than 80 and, in subjects younger than 80, 0\u201330\u2009cm\n                      <jats:sup>3<\/jats:sup>\n                      with NIHSS 10\u201320 and 31\u201350\u2009cm\n                      <jats:sup>3<\/jats:sup>\n                      with NIHSS \u226521).\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Design<\/jats:title>\n                    <jats:p>Prospective, randomized, multicenter, Bayesian adaptive-enrichment, open label trial with blinded endpoint assessment. For the purpose of enrolment, ischemic core size will be evaluated by CT perfusion or magnetic resonance imaging-diffusion-weighted imaging measured by automated software (RAPID).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Procedures<\/jats:title>\n                    <jats:p>Subjects with acute ischemic stroke due to computed tomography angiography- or magnetic resonance angiogram-proven arterial occlusion of the intracranial internal carotid and\/or proximal middle cerebral artery (M1) with age-adjusted clinical core mismatch in whom treatment can be initiated between 6 and 24\u2009h from TSLW are randomized in a 1:1 ratio to receive mechanical embolectomy with the Trevo device or medical management alone. Sequential interim analyses allowing adaptation of enrolment criteria or stopping new enrolment for futility or predicted success will occur in every 50 randomized patients starting at 150 to a maximum of 500 patients.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Study outcomes<\/jats:title>\n                    <jats:p>The primary endpoint is the modified Rankin Scale score at 90 days. The primary safety outcome is stroke-related mortality at 90 days.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Analysis<\/jats:title>\n                    <jats:p>The primary endpoint, expressed as a utility-weighted modified Rankin Scale score is analyzed using a Bayesian posterior probability with adjustment for ischemic core size. For regulatory reasons, a nested co-primary endpoint analysis was added consisting of the proportion of subjects with modified Rankin Scale 0\u20132 between the active and control groups also analyzed using a Bayesian model.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/1747493017710341","type":"journal-article","created":{"date-parts":[[2017,6,1]],"date-time":"2017-06-01T07:55:38Z","timestamp":1496303738000},"page":"641-652","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":177,"title":["Diffusion-weighted imaging or computerized tomography perfusion assessment with clinical mismatch in the triage of wake up and late presenting strokes undergoing neurointervention with Trevo (DAWN) trial methods"],"prefix":"10.1177","volume":"12","author":[{"given":"Tudor G","family":"Jovin","sequence":"first","affiliation":[{"name":"UPMC, Presbyterian University Hospital, Pittsburgh, PA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jeffrey L","family":"Saver","sequence":"additional","affiliation":[{"name":"UCLA Stroke Center, Los Angeles, CA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marc","family":"Ribo","sequence":"additional","affiliation":[{"name":"Hospital Vall d'Hebron, Barcelona, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vitor","family":"Pereira","sequence":"additional","affiliation":[{"name":"Toronto Western Hospital, Toronto, Ontario, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anthony","family":"Furlan","sequence":"additional","affiliation":[{"name":"University Hospitals Cleveland Medical Center, Cleveland, OH, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alain","family":"Bonafe","sequence":"additional","affiliation":[{"name":"H\u00f4pital Gui-de-Chauliac, Montpellier, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Blaise","family":"Baxter","sequence":"additional","affiliation":[{"name":"Erlanger Health System, Chattanooga, TN, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rishi","family":"Gupta","sequence":"additional","affiliation":[{"name":"WellStar Kennestone Hospital, Marietta, GA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Demetrius","family":"Lopes","sequence":"additional","affiliation":[{"name":"Rush University Medical Center, Chicago, IL, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Olav","family":"Jansen","sequence":"additional","affiliation":[{"name":"Universit\u00e4tsklinikum Schleswig-Holstein, Kiel, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wade","family":"Smith","sequence":"additional","affiliation":[{"name":"University of California, San Francisco, Medical Center, San Francisco, CA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daryl","family":"Gress","sequence":"additional","affiliation":[{"name":"University of Nebraska Medical Center, Omaha, NE, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Steven","family":"Hetts","sequence":"additional","affiliation":[{"name":"Radiology and Biomedical Imaging, University of California, San Francisco, Medical Center, San Francisco, CA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Roger J","family":"Lewis","sequence":"additional","affiliation":[{"name":"Los Angeles County Harbor, UCLA Medical Center, Torrance, CA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ryan","family":"Shields","sequence":"additional","affiliation":[{"name":"Stryker Neurovascular, Fremont, CA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Scott M","family":"Berry","sequence":"additional","affiliation":[{"name":"Berry Consultants, LLC, Austin, TX, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Todd L","family":"Graves","sequence":"additional","affiliation":[{"name":"Berry Consultants, LLC, Austin, TX, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tim","family":"Malisch","sequence":"additional","affiliation":[{"name":"Alexian Brothers Health System, Elk Grove Village, IL, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ansaar","family":"Rai","sequence":"additional","affiliation":[{"name":"West-Virginia-University-Hospitals, Ruby-Memorial-Hospital, Morgantown, WV, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kevin N","family":"Sheth","sequence":"additional","affiliation":[{"name":"Yale New Haven University Hospital, Yale, New Haven, CT, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David S","family":"Liebeskind","sequence":"additional","affiliation":[{"name":"UCLA Stroke Center, Los Angeles, CA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Raul G","family":"Nogueira","sequence":"additional","affiliation":[{"name":"Grady Memorial Hospital and Emory University, Atlanta, GA, 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