To assess the safety and feasibility of Volcano Corp Eagle Eye Gold Catheter system to correlate the presence and characteristic of carotid artery atherosclerotic disease with anatomic and histologic analysis.
A Phase , single center, prospective safety and feasibility study in patients diagnosed with carotid artery disease requiring intervention (carotid endarterectomy(CEA) or carotid artery stenting (CAS) with distal protection) as determined by the attending physician per standard treatment guidelines. At the time of the procedure, patients will undergo peri-operative assessment of their carotid artery disease with the study device.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
31
Arizona Heart Institute
Phoenix, Arizona, United States
Primary endpoint: the completion of plaque morphology assessment & correlation of in-vitro histology with in-vivo histology using the Eagle Eye Gold Catheter.
Secondary endpoint: safety and feasibility of the catheter system with respect to the possibility of assisting with the selection of a carotid stent, the relevance of pre-stent ballooning and ultimately the best treatment modality.
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