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The Mo.Ma™ Ultra proximal cerebral protection device was evaluated in the ARMOUR Trial,1 a multicenter clinical study, during carotid artery stenting of a total of 262 high surgical risk patients with critical artery stenosis. The ARMOUR Trial primary endpoint (MACCE) was a composite endpoint of any myocardial infarction, stroke or death at 30 days post-procedure. The primary endpoint analysis was based upon 220 evaluable intent‑to‑treat patients (ITT).
304-day event rates 220 patients (ITT).
ARMOUR Clinical Study Report, Ansel, et al. Cath Cardiovasc Interv 76:1-8 (2010)