{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,29]],"date-time":"2026-05-29T17:41:42Z","timestamp":1780076502453,"version":"3.54.0"},"reference-count":51,"publisher":"Wiley","issue":"3","license":[{"start":{"date-parts":[[2010,11,3]],"date-time":"2010-11-03T00:00:00Z","timestamp":1288742400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Cathet Cardio Intervent"],"published-print":{"date-parts":[[2011,2,15]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p><jats:styled-content>Background<\/jats:styled-content>: Each of the embolic protection devices used in carotid artery stenting (CAS) has advantages and disadvantages. The prospective, multicenter, single\u2010arm EMPiRE Clinical Study investigated a proximally placed device (GORE Flow Reversal System) that provides distal neuroprotection during CAS by reversing blood flow in the internal carotid artery, thereby directing emboli away from the brain. <jats:styled-content>Methods<\/jats:styled-content>: The study evaluated 30\u2010day outcomes in 245 pivotal high\u2010surgical\u2010risk patients (mean age, 70 years; 32% symptomatic; 16% \u226580\u2010years old) with carotid stenosis who underwent CAS using the flow reversal system. The primary endpoint was a major adverse event (MAE; stroke, death, myocardial infarction, or transient ischemic attack) within 30 days of CAS. The MAE rate was compared with an objective performance criterion (OPC) derived from CAS studies that included embolic protection. <jats:styled-content>Results<\/jats:styled-content>: The MAE rate was 4.5% (11 patients; <jats:italic>P<\/jats:italic> = 0.002 compared with the OPC). The stroke and death rate was 2.9%. No patient had a major ischemic stroke. Six patients (2.4%) had intolerance to flow reversal. The death and stroke rates in the symptomatic, asymptomatic, and octogenarian subgroups were 2.6, 3, and 2.6%, respectively, meeting American Heart Association guidelines for carotid endarterectomy. <jats:styled-content>Conclusion<\/jats:styled-content>: The stroke and death rate in this study was among the lowest in CAS trials. The results indicate that the flow reversal system is safe and effective when used for neuroprotection during CAS and that it provides benefits in a broad patient population. \u00a9 2010 Wiley\u2010Liss, Inc.<\/jats:p>","DOI":"10.1002\/ccd.22789","type":"journal-article","created":{"date-parts":[[2010,9,17]],"date-time":"2010-09-17T18:57:26Z","timestamp":1284749846000},"page":"420-429","source":"Crossref","is-referenced-by-count":79,"title":["Neuroprotection during carotid artery stenting using the GORE flow reversal system: 30\u2010day outcomes in the EMPiRE Clinical Study"],"prefix":"10.1002","volume":"77","author":[{"given":"Daniel G.","family":"Clair","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"L. 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