Safety and effectiveness of the INVATEC MO.MA proximal cerebral protection device during carotid artery stenting: results from the ARMOUR pivotal trial.
OBJECTIVE
The multicenter ARMOUR (ProximAl PRotection with the MO.MA Device DUring CaRotid Stenting) trial evaluated the 30-day safety and effectiveness of the MO.MA Proximal Cerebral Protection Device (Invatec, Roncadelle, Italy) utilized to treat high surgical risk patients undergoing carotid artery stenting (CAS).


BACKGROUND
Distal embolic protection devices (EPD) have been traditionally utilized during CAS. The MO.MA device acts as a balloon occlusion "endovascular clamping" system to achieve cerebral protection prior to crossing the carotid stenosis.


METHODS
This prospective registry enrolled 262 subjects, 37 roll-in 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-day major adverse cardiac and cerebrovascular events [MACCE]) was compared to a performance goal of 13% derived from trials utilizing distal EPD.


RESULTS
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-day MACCE rate was 2.7% [95% CI (1.0-5.8%)] with a 30-day major stroke rate of 0.9%. No symptomatic patient suffered a stroke during this trial.


CONCLUSIONS
The ARMOUR trial demonstrated that the MO.MA(R) 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.
Ansel
Gary M
GM
Department of Cardiology, Riverside Methodist Hospital, 3705 Olentangy River Road, Columbus, OH 43214, USA. gansel@mocvc.com
Hopkins
L Nelson
LN
Jaff
Michael R
MR
Rubino
Paolo
P
Bacharach
J Michael
JM
Scheinert
Dierk
D
Myla
Subbarao
S
Das
Tony
T
Cremonesi
Alberto
A
D000368:Aged; D000369:Aged, 80 and over; D017130:Angioplasty / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D021721:Balloon Occlusion / Q000295:instrumentation*; D016893:Carotid Stenosis / Q000175:diagnosis / Q000401:mortality / Q000628:therapy*; D004867:Equipment Design; D005060:Europe; D005260:Female; D006801:Humans; D020766:Intracranial Embolism / Q000209:etiology / Q000401:mortality / Q000517:prevention & control*; D053208:Kaplan-Meier Estimate; D008297:Male; D009203:Myocardial Infarction / Q000209:etiology; D011446:Prospective Studies; D012042:Registries; D018570:Risk Assessment; D012720:Severity of Illness Index; D015607:Stents; D020521:Stroke / Q000209:etiology / Q000517:prevention & control; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States