{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,9]],"date-time":"2026-10-09T06:00:58Z","timestamp":1791525658747,"version":"4.3.4"},"reference-count":28,"publisher":"Wiley","issue":"3","license":[{"start":{"date-parts":[[2025,11,24]],"date-time":"2025-11-24T00:00:00Z","timestamp":1763942400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"},{"start":{"date-parts":[[2025,11,24]],"date-time":"2025-11-24T00:00:00Z","timestamp":1763942400000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Annals of Neurology"],"published-print":{"date-parts":[[2026,3]]},"abstract":"<jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>To evaluate the real\u2010world safety and efficacy for standard surgical risk patients with extracranial internal carotid artery disease undergoing transcarotid artery revascularization.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>ROADSTER 3 is a prospective, multicenter, single\u2010arm post\u2010approval study. Patients &lt;80\u2009years old without anatomic or physiologic high\u2010risk factors were included. Thirty\u2010day incidence of major adverse events (stroke, death, or myocardial infarction) and cranial nerve injury were assessed. An independent clinical events committee adjudicated events, and independent certified health care personnel performed neurological assessments.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Between 2022 and 2024, 344 patients (intent to treat population) were enrolled at 48 sites in the United States. Because of 24 major protocol deviations, 320 patients remained in the Food and Drug Administration's analysis population (per protocol). In the per protocol population, there were 136 (42.5%) females and 49 (15.3%) symptomatic patients. Among symptomatic patients, 12 (24.5%) were treated within 2\u2009weeks of the prior event. Technical success was 100%. For the entire study population, there were strokes in 3 patients with no instances of death or myocardial infarction. The 2 instances of cranial nerve injury (0.6%; 95% CI, 0.1\u20132.2% in the per protocol population) both resolved within 6\u2009months. The composite 30\u2010day stroke\/death\/myocardial infarction rate was 0.6% (95% CI, 0.1\u20132.2%) for the per protocol population and 0.9% (95% CI, 0.2\u20132.5%) for the intent to treat population.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Interpretation<\/jats:title>\n                    <jats:p>The 30\u2010day results of the ROADSTER 3 study confirm that transcarotid artery revascularization is safe and effective in the standard\u2010risk population. Longer\u2010term follow\u2010up is pending to confirm durable stroke prevention for these patients. ANN NEUROL 2026;99:705\u2013712<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/ana.78104","type":"journal-article","created":{"date-parts":[[2025,11,24]],"date-time":"2025-11-24T13:07:53Z","timestamp":1763989673000},"page":"705-712","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":5,"title":["Prospective, Multicenter Evaluation of Transcarotid Artery Revascularization in Standard\u2010Risk Patients: 30\u2010Day Outcomes of the\n                    <scp>ROADSTER<\/scp>\n                    3 Study"],"prefix":"10.1002","volume":"99","author":[{"given":"Jeffrey","family":"Jim","sequence":"first","affiliation":[{"name":"Vascular and Endovascular Surgery Minneapolis Heart Institute  Minneapolis MN"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Meghan","family":"Dermody","sequence":"additional","affiliation":[{"name":"Division of Vascular Surgery Penn Medicine Lancaster General Hospital  Lancaster PA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Brian","family":"Peterson","sequence":"additional","affiliation":[{"name":"Department of Surgery St. Luke's Hospital  Chesterfield MO"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Scott S.","family":"Berman","sequence":"additional","affiliation":[{"name":"Section of Vascular Surgery The University of Arizona  Tucson AZ"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nicolas J.","family":"Mouawad","sequence":"additional","affiliation":[{"name":"Division of Vascular and Endovascular Surgery McLaren Health  Bay City MI"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joseph","family":"Ricotta","sequence":"additional","affiliation":[{"name":"Department of Vascular Surgery Delray Medical Center  Delray Beach FL"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Naveed","family":"Saqib","sequence":"additional","affiliation":[{"name":"Department of Cardiothoracic and Vascular Surgery University of Texas Health Sciences Center at Houston (UTHealth Houston); 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