Carotid Artery Stenting With Protection Registry

Providence Health & Services

Status and phase

Completed

Phase 3

Conditions

Carotid Artery Stenosis

Treatments

Device: Carotid Stent with Distal Protection Device

Study type

Interventional

Funder types

Other

Identifiers

NCT00318851

HI473

Details and patient eligibility

About

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

Full 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.

Enrollment

62 patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

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