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Clinical Trial Summary

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.


Clinical Trial Description

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00271076
Study type Interventional
Source Arizona Heart Institute
Contact
Status Completed
Phase Phase 1
Start date January 2006
Completion date September 2007

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