Carotid Artery Stenting With Protection Registry

Treatment of Carotid Stenosis With Carotid Stenting and Neurologic Protection With Pre-Procedure and Follow-Up With MRI DIffusion Imaging and Neuropsychological Testing

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

Study Overview

• Status: Completed
• Conditions: Carotid Artery Stenosis
• Intervention / Treatment: Device: Carotid Stent with Distal Protection 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.

• Study Type: Interventional
• Enrollment (Actual): 62
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Washington
    • Spokane, Washington, United States, 99204
      • Sacred Heart Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Carotid Artery Stenting	Device: Carotid Stent with Distal Protection Device; Carotid Stent Placement with Distal Protection; Other Names: Carotid Artery Stenting; Neurocognitive evaluation in Carotid Artery Stenting

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of new diffusion weighted abnormalities post-procedure	24 hours post stent placement

Secondary Outcome Measures

Outcome Measure	Time Frame
Neuropsychological stability or deterioration	3 months post procedure
Neuropsychological stability or deterioration	6 months post procedure
Neuropsychological stability or deterioration	12 months post procedure
Acute versus delayed neuropsychological changes	1-7 days post procedure
Acute versus delayed neuropsychological changes	3 months post procedure
Acute versus delayed neuropsychological changes	6 months post procedure
Acute versus delayed neuropsychological changes	12 months post procedure
Stroke and death	1 month
Stroke and death	6 months
Stroke and death	12 months
NIH stroke scale changes	24 hours post procedure
NIH stroke scale changes	1 month post procedure
NIH stroke scale changes	6 months post procedure
NIH stroke scale changes	12 months post procedure

Collaborators and Investigators

• Sponsor: Providence Health & Services
• Investigators: Principal Investigator: Rodney D. Raabe, MD, Providence Health & Services

Study record dates

Study Major Dates

• Study Start: September 1, 2003
• Primary Completion (Actual): August 1, 2007
• Study Completion (Actual): August 1, 2007

Study Registration Dates

• First Submitted: April 25, 2006
• First Submitted That Met QC Criteria: April 25, 2006
• First Posted (Estimate): April 27, 2006

Study Record Updates

• Last Update Posted (Estimate): August 26, 2010
• Last Update Submitted That Met QC Criteria: August 25, 2010
• Last Verified: March 1, 2006

More Information

Terms related to this study

• Keywords: Stroke; Carotid Artery stenting
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arterial Occlusive Diseases; Pathological Conditions, Anatomical; Carotid Artery Diseases; Carotid Stenosis; Constriction, Pathologic
• Other Study ID Numbers: HI473