Methods
All subjects who provided informed consent and met inclusion/exclusion criteria underwent percutaneous revascularization of the carotid artery using the MO.MA device and a stent approved by the FDA for carotid artery stenting. Follow-up took place at predischarge and at 30 days postprocedure. A total of 262 subjects (225 ITT, 37 roll-in) were enrolled at 25 investigational sites in the United States (20) and the European Union (5) between September 2007 and February 2009. For the ITT population, mean age was 74.7 years and 66.7% were male. Symptomatic subjects comprised 15.1% of the population and 28.9% of the subjects were octogenarians. The primary end point for this trial was major adverse cardiac and cerebrovascular events (MACCE) within 30 days of stent implantation. MACCE was defined as any myocardial infarction (MI), stroke, or death through 30 days postprocedure as adjudicated by the Clinical Events Committee (CEC). Results were compared to a performance goal of 13% for the 30-day MACCE composite rate, which was derived from previous carotid stenting trials. Secondary end points included device, technical, and procedural success.
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