The purpose of this study is to evaluate ischemic events and neuropsychological changes after carotid artery angioplasty and stenting with a neuroprotection device.
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 distribution of the carotid arteries. Among those, a thrombotic etiology (carotid occlusive disease) is one of the most common causes. Recently published studies have shown that patients who underwent carotid stenting in combination with a cerebral protection device had better overall outcomes as related to stroke, death and MI as opposed to carotid endarterectomy. What is not known is whether protection devices which allow some particles (100 micron particle size or less) to pass through the filter or particles that embolize during placement or removal of the protection device, will have any delayed abnormal outcomes as determined by neuropsychological testing.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
62
Carotid Stent Placement with Distal Protection
Sacred Heart Medical Center
Spokane, Washington, United States
Number of new diffusion weighted abnormalities post-procedure
Time frame: 24 hours post stent placement
Neuropsychological stability or deterioration
Time frame: 3 months post procedure
Neuropsychological stability or deterioration
Time frame: 6 months post procedure
Neuropsychological stability or deterioration
Time frame: 12 months post procedure
Acute versus delayed neuropsychological changes
Time frame: 1-7 days post procedure
Acute versus delayed neuropsychological changes
Time frame: 3 months post procedure
Acute versus delayed neuropsychological changes
Time frame: 6 months post procedure
Acute versus delayed neuropsychological changes
Time frame: 12 months post procedure
Stroke and death
Time frame: 1 month
Stroke and death
Time frame: 6 months
Stroke and death
Time frame: 12 months
NIH stroke scale changes
Time frame: 24 hours post procedure
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NIH stroke scale changes
Time frame: 1 month post procedure
NIH stroke scale changes
Time frame: 6 months post procedure
NIH stroke scale changes
Time frame: 12 months post procedure