Status:
COMPLETED
Carotid Artery Stenting With Protection Registry
Lead Sponsor:
Providence Health & Services
Conditions:
Carotid Artery Stenosis
Eligibility:
All Genders
18-90 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate ischemic events and neuropsychological changes after carotid artery angioplasty and stenting with a neuroprotection device.
Detailed Description
Stroke is the third most common cause of death in North America with approximately 750,000 new strokes reported annually, of which 150,000 are fatal. Approximately 75% of strokes occur in the distribu...
Eligibility Criteria
Inclusion
- Age greater than 18 and less than 90
- Symptomatic as evidenced by transient ischemic attack or non-disabling stroke in the hemisphere supplied by the target vessel within 180 days of procedure. Must have anatomic stenosis greater than 70% by ultrasound or angiography performed in previous 30 days
- Asymptomatic patients with a stenosis greater than 80% by ultrasound or angiography performed in previous 30 days
- Patient has no childbearing potential or has negative pregnancy tests within one week prior to procedure.
- Patient and patient's physician agree to have the patient return for all the required clinical contacts following study enrollment
- Patient signs informed consent
- Patient has been excluded from other multi-institutional trials
Exclusion
- Patient has evolving stroke or intracranial hemorrhage
- Allergy to trial required medications
- Active bleeding diathesis or coagulopathy, or will refuse blood transfusions
- History of major ipsilateral stroke with sufficient atrophy to increase risk of procedure associated bleed
- Severe dementia
- Previous intracranial hemorrhage or brain surgery within the past twelve months
- Patient has any condition that precludes angiography or would make a percutaneous procedure unsafe
- Patient or family inability to understand or cooperate with study procedures
- Recent GI or remote bleed that would interfere with anti-plate therapy
- Severe vessel tortuosity or calcification that would preclude introduction of guiding catheter, guiding sheath, or stent placement
- Extensive diffuse atherosclerotic disease involving the arch or common carotid that would preclude safe introduction of catheters and sheaths for endovascular therapy
- Intraluminal filling defect
- Intracranial aneurysm greater than 6 mm, AVM, or other intracranial vascular abnormality that would preclude safe intravascular intervention
Key Trial Info
Start Date :
September 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2007
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT00318851
Start Date
September 1 2003
End Date
August 1 2007
Last Update
August 26 2010
Active Locations (1)
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1
Sacred Heart Medical Center
Spokane, Washington, United States, 99204