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.

Condition	Intervention	Phase
Carotid Artery Disease	Procedure: IVUS  Device: CAS  Procedure: CEA	Phase I

Further study details as provided by ARIZONA HEART INSTITUTE:

Primary Outcomes: Primary endpoint: the completion of plaque morphology assessment & correlation of in-vitro histology with in-vivo histology using the Eagle Eye Gold Catheter.
Secondary Outcomes: 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.
Expected Total Enrollment:  30

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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

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.

Please refer to this study by ClinicalTrials.gov identifier  NCT00271076

Arizona
      Arizona Heart Institute, Phoenix,  Arizona,  85006,  United States

Study chairs or principal investigators

Edward B Diethrich, M.D.,  Principal Investigator,  ARIZONA HEART INSTITUTE   
Grayson H Wheatley, M.D.,  Study Director,  ARIZONA HEART INSTITUTE   

Study ID Numbers:  AHI # 1119; Volcano Therapeutics
Last Updated:  December 29, 2005
Record first received:  December 29, 2005
ClinicalTrials.gov Identifier:  NCT00271076
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2006-01-10