Clinical trial NCT00318851: Carotid Artery Stenting With Protection Registry
Official title: Treatment of Carotid Stenosis With Carotid Stenting and Neurologic Protection With Pre-Procedure and Follow-Up With MRI DIffusion Imaging and Neuropsychological Testing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Carotid Artery Stenosis
Keywords: Carotid Artery stenting
Stroke
Lead sponsor: Providence Health & Services
Sponsor class: OTHER
First posted: 2006-04-27
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Number of new diffusion weighted abnormalities post-procedure
timeFrame: 24 hours post stent placement
Secondary outcomes:
measure: Neuropsychological stability or deterioration
timeFrame: 3 months post procedure
measure: Neuropsychological stability or deterioration
timeFrame: 6 months post procedure
measure: Neuropsychological stability or deterioration
timeFrame: 12 months post procedure
measure: Acute versus delayed neuropsychological changes
timeFrame: 1-7 days post procedure
measure: Acute versus delayed neuropsychological changes
timeFrame: 3 months post procedure
measure: Acute versus delayed neuropsychological changes
timeFrame: 6 months post procedure
measure: Acute versus delayed neuropsychological changes
timeFrame: 12 months post procedure
measure: Stroke and death
timeFrame: 1 month
measure: Stroke and death
timeFrame: 6 months
measure: Stroke and death
timeFrame: 12 months
measure: NIH stroke scale changes
timeFrame: 24 hours post procedure
measure: NIH stroke scale changes
timeFrame: 1 month post procedure
measure: NIH stroke scale changes
timeFrame: 6 months post procedure
measure: NIH stroke scale changes
timeFrame: 12 months post procedure
Other outcomes:
Locations:
city: Spokane
country: United States
facility: Sacred Heart Medical Center
state: Washington
Study officials:
affiliation: Providence Health & Services
name: Rodney D. Raabe, MD
role: PRINCIPAL_INVESTIGATOR
References: