{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,11]],"date-time":"2026-10-11T06:21:11Z","timestamp":1791699671388,"version":"4.3.4"},"reference-count":18,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2010,1,25]],"date-time":"2010-01-25T00:00:00Z","timestamp":1264377600000},"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":[[2010,7]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p><jats:styled-content>Objective<\/jats:styled-content>: The multicenter ARMOUR (Proxim<jats:bold>A<\/jats:bold>l P<jats:bold>R<\/jats:bold>otection with the <jats:bold>MO<\/jats:bold>.MA Device D<jats:bold>U<\/jats:bold>ring Ca<jats:bold>R<\/jats:bold>otid Stenting) trial evaluated the 30\u2010day safety and effectiveness of the MO.MA\u00ae Proximal Cerebral Protection Device (Invatec, Roncadelle, Italy) utilized to treat high surgical risk patients undergoing carotid artery stenting (CAS). <jats:styled-content>Background<\/jats:styled-content>: Distal embolic protection devices (EPD) have been traditionally utilized during CAS. The MO.MA device acts as a balloon occlusion \u201cendovascular clamping\u201d system to achieve cerebral protection prior to crossing the carotid stenosis. <jats:styled-content>Methods<\/jats:styled-content>: This prospective registry enrolled 262 subjects, 37 roll\u2010in and 225 pivotal subjects evaluated with intention to treat (ITT) from September 2007 to February 2009. Subjects underwent CAS using the MO.MA device. The primary endpoint, myocardial infarction, stroke, or death through 30 days (30\u2010day major adverse cardiac and cerebrovascular events [MACCE]) was compared to a performance goal of 13% derived from trials utilizing distal EPD. <jats:styled-content>Results<\/jats:styled-content>: For the ITT population, the mean age was 74.7 years with 66.7% of the cohort being male. Symptomatic patients comprised 15.1% and 28.9% were octogenarians. Device success was 98.2% and procedural success was 93.2%. The 30\u2010day MACCE rate was 2.7% [95% CI (1.0\u20135.8%)] with a 30\u2010day major stroke rate of 0.9%. No symptomatic patient suffered a stroke during this trial. <jats:styled-content>Conclusions<\/jats:styled-content>: The ARMOUR trial demonstrated that the MO.MA\u00ae Proximal Cerebral Protection Device is safe and effective for high surgical risk patients undergoing CAS. The absence of stroke in symptomatic patients is the lowest rate reported in any independently adjudicated prospective multicenter registry trial to date. \u00a9 2010 Wiley\u2010Liss, Inc.<\/jats:p>","DOI":"10.1002\/ccd.22439","type":"journal-article","created":{"date-parts":[[2010,1,25]],"date-time":"2010-01-25T16:08:43Z","timestamp":1264435723000},"page":"1-8","source":"Crossref","is-referenced-by-count":136,"title":["Safety and effectiveness of the INVATEC MO.MA\u00ae proximal cerebral protection device during carotid artery stenting: Results from the ARMOUR pivotal trial"],"prefix":"10.1002","volume":"76","author":[{"given":"Gary M.","family":"Ansel","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"L. 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