Carotid Artery Disease Clinical Trial
Official title:
ARMOUR: Proximal Protection With The Mo.Ma Device During Carotid Stenting
The objective of the ARMOUR study is to evaluate the safety and effectiveness of the Mo.Ma proximal flow blockage cerebral protection device for patients at high surgical risk for carotid endarterectomy who undergo carotid artery stenting
Test Device:
Mo.Ma™ Proximal Flow Blockage Cerebral Protection Device. Single size catheter device with a
9 French introducer sheath compatible shaft (outer diameter) and a 6 French compatible
working channel (inner diameter), integrating two compliant balloons intended to achieve
endovascular clamping of external carotid arteries (ECA) 3-6 mm in diameter and common
carotid arteries (CCA) 5-13 mm in diameter.
Primary Objective:
Evaluate the safety and effectiveness of the Mo.Ma device for cerebral protection in the
treatment of internal carotid artery (ICA) stenoses, which may or may not involve the
bifurcation of the CCA, in subjects considered to be at high surgical risk for complications
during carotid endarterectomy (CEA).
Primary Endpoint:
Major adverse cardiac and cerebrovascular events (MACCE) within 30 days of implantation.
MACCE are defined as: any myocardial infarction (MI), stroke, or death through day 30
post-procedure.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
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