CAPITAL: Carotid Artery Plaque Intravascular Ultrasound Evaluation
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.
Carotid Artery Disease
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Carotid Artery Plaque Intravascular Ultrasound Evaluation|
- 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.
|Study Start Date:||January 2006|
|Study Completion Date:||September 2007|
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.
|United States, Arizona|
|Arizona Heart Institute|
|Phoenix, Arizona, United States, 85006|
|Principal Investigator:||Edward B Diethrich, M.D.||Arizona Heart Institute|
|Study Director:||Grayson H Wheatley, M.D.||Arizona Heart Institute|