Carotid Artery Stenting With Protection Registry

Completed · Phase 3

Conditions studied: Carotid Artery Stenosis

In brief

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

Key facts

Study ID

NCT00318851

Run by

Providence Health & Services

People needed

62

Starts

2003-09-01

Expected to finish

2007-08-01

Last updated by the study team

2010-08-26

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Sacred Heart Medical Center — Spokane, Washington, United States

Full record on ClinicalTrials.gov

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