ARMOUR Data Published for Mo.Ma Cerebral Protection Device

July 23, 2010—Gary M. Ansel, MD, et al have published data from the multicenter ARMOUR (Proximal Protection With the Mo.Ma Device During Carotid Stenting) trial in Catheterization and Cardiovascular Interventions (2010;76:1–8). Robert M. Bersin, MD, presented the findings on May 6, 2010 at the Society for Cardiovascular Angiography and Interventions 33rd annual scientific sessions, which was reported by Endovascular Today.

ARMOUR evaluated the 30-day safety and effectiveness of the Mo.Ma proximal cerebral protection device (Medtronic Invatec, Frauenfeld, Switzerland) used to treat high-surgical-risk patients undergoing carotid artery stenting (CAS). Whereas distal embolic protection devices have been traditionally used during CAS, the Mo.Ma device acts as a balloon-occlusion ‘‘endovascular clamping'' system to achieve cerebral protection before crossing the carotid stenosis, the investigators noted.

As detailed by the investigators, this prospective registry enrolled 262 subjects, including 37 roll-in and 225 pivotal subjects evaluated with intention to treat from September 2007 to February 2009. Patients underwent CAS using the Mo.Ma device. The primary endpoint—myocardial infarction, stroke, or death through 30 days (30-day major adverse cardiac and cerebrovascular events)—was compared to a performance goal of 13% derived from trials using distal embolic protection devices. For the intention-to-treat population, the mean age was 74.7 years, and 66.7% of the cohort were men. Symptomatic patients comprised 15.1%, and 28.9% of patients were octogenarians.

The investigators reported that the device success rate was 98.2%, and the procedural success rate was 93.2%. The 30-day major adverse cardiac and cerebrovascular events rate was 2.7% [95% confidence interval, 1%–5.8%], with a 30-day major stroke rate of 0.9%. No symptomatic patient suffered a stroke during the trial.

The ARMOUR trial showed that the Mo.Ma proximal cerebral protection device is safe and effective for high-surgical-risk patients undergoing CAS. Furthermore, the absence of stroke in symptomatic patients is the lowest rate reported in any independently adjudicated, prospective, multicenter registry trial to date, the investigators concluded.