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| ID | Type | Description | Link |
|---|---|---|---|
| Volcano Therapeutics |
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| Name | Class |
|---|---|
| Volcano Corporation | INDUSTRY |
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IVUS | Procedure | |||
| CAS | Device | |||
| CEA | Procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Primary endpoint: the completion of plaque morphology assessment & correlation of in-vitro histology with in-vivo histology using the Eagle Eye Gold Catheter. |
| Measure | Description | Time Frame |
|---|---|---|
| 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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Inclusion Criteria:
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.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Edward B Diethrich, M.D. | Arizona Heart Institute | Principal Investigator |
| Grayson H Wheatley, M.D. | Arizona Heart Institute | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Heart Institute | Phoenix | Arizona | 85006 | United States |
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| ID | Term |
|---|---|
| D002340 | Carotid Artery Diseases |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |