Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
Arizona Heart Institute Volcano Corporation |
---|---|
Information provided by: | Arizona Heart Institute |
ClinicalTrials.gov Identifier: | NCT00271076 |
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 |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment, Safety Study |
Official Title: | Carotid Artery Plaque Intravascular Ultrasound Evaluation |
Enrollment: | 31 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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:
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 |
Study ID Numbers: | AHI # 1119, Volcano Therapeutics |
Study First Received: | December 29, 2005 |
Last Updated: | October 24, 2007 |
ClinicalTrials.gov Identifier: | NCT00271076 |
Health Authority: | United States: Food and Drug Administration |
CAD CEA CAS IVUS symptomatic |
asymptomatic Cerebral Protection Device TIA Stroke plaque morphology |
Arterial Occlusive Diseases Carotid Stenosis Cerebral Infarction Stroke Vascular Diseases Central Nervous System Diseases |
Constriction, Pathologic Brain Diseases Carotid Artery Diseases Cerebrovascular Disorders Coronary Artery Disease |
Nervous System Diseases Cardiovascular Diseases |