Carotid Artery Stenting With Protection Registry

Carotid Artery Stenosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00318851
• Other study ID #: HI473
• Status: Completed
• Phase: Phase 3
• First received: April 25, 2006
• Last updated: August 25, 2010
• Start date: September 2003
• Est. completion date: August 2007

Study information

• Verified date: March 2006
• Source: Providence Health & Services
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate ischemic events and neuropsychological changes after carotid artery angioplasty and stenting with a neuroprotection device.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: August 2007
• Est. primary completion date: August 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carotid Artery Stenosis
• Carotid Stenosis

Intervention

Device:
• Carotid Stent with Distal Protection Device
Carotid Stent Placement with Distal Protection

Locations

Country	Name	City	State
United States	Sacred Heart Medical Center	Spokane	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Providence Health & Services

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of new diffusion weighted abnormalities post-procedure		24 hours post stent placement	No
Secondary	Neuropsychological stability or deterioration		3 months post procedure	No
Secondary	Neuropsychological stability or deterioration		6 months post procedure	No
Secondary	Neuropsychological stability or deterioration		12 months post procedure	No
Secondary	Acute versus delayed neuropsychological changes		1-7 days post procedure	No
Secondary	Acute versus delayed neuropsychological changes		3 months post procedure	No
Secondary	Acute versus delayed neuropsychological changes		6 months post procedure	No
Secondary	Acute versus delayed neuropsychological changes		12 months post procedure	No
Secondary	Stroke and death		1 month	No
Secondary	Stroke and death		6 months	No
Secondary	Stroke and death		12 months	No
Secondary	NIH stroke scale changes		24 hours post procedure	No
Secondary	NIH stroke scale changes		1 month post procedure	No
Secondary	NIH stroke scale changes		6 months post procedure	No
Secondary	NIH stroke scale changes		12 months post procedure	No