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).
30-day event rates 220 patients (ITT).
Ansel GM, Hopkins LN, Jaff MR, et al. Safety and effectiveness of the INVATEC MO.MA proximal cerebral protection device during carotid artery stenting: results from the ARMOUR pivotal trial. Catheter Cardiovasc Interv. July 1, 2010;76(1):1-8.