CAPITAL: Carotid Artery Plaque Intravascular Ultrasound Evaluation
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.
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.
Inclusion Criteria:

 -  >18 years of age

 -  Patient must be:

 Symptomatic with lesions >/= to 50% stenosis, or Asymptomatic with lesions of >/= to 75%
 stenosis in at least one carotid artery, specific to the internal carotid artery, common
 carotid artery or bifurcated region; documented through acceptable ultrasound studies,
 completed within 30 days of recruitment.

 -  For patients with bilateral carotid disease- procedures need to be staged greater than
 30 days apart. The lesion that has a greater degree of stenosis will be considered as
 the index procedure.

 -  Women of childbearing potential must have a negative pregnancy test within 7 days
 prior to treatment.

 -  The patient is able to give informed consent.

 Exclusion Criteria:

 -  The patient is experiencing a new (acute) neurologic event or has experienced a stroke
 within the last 30 days prior to enrollment.

 -  The patient has intracranial tumors, arterial vascular malformations >5mm, aneurysms
 or severe intracranial stenosis distal to the target lesion.

 -  Presence of thrombus at the target site or loose 'floating' debris as determined by
 duplex analysis and/or angiography.

 -  Existing hemorrhagic disease or coagulation problems creating inability to obtain
 homeostasis at entry site.

 -  The patient has an allergy to, or is unable to tolerate, heparin, concomitant
 medications (clopidogrel or ticlid, aspirin) or to nitinol metal.

 -  The patient has a history of or known reaction to radiocontrast agent (radiopaque dye)
 and is unable to be premedicated.

 -  Coumadin treatment that has continued during the 48 hours prior to enrollment and an
 INR above hospital normals (i.e. in the event of atrial fibrillation or prosthetic
 valve replacement).

 -  Hemodynamic instability at the time of intervention.

 -  Severe chronic renal insufficiency (plasma/ serum creatinine> 2.5 mg/dL) at the time
 of intervention, except in patients on dialysis.