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Carotid Artery Stenting With Protection Registry

This study has been completed.
Sponsor:
Information provided by:
Providence Health & Services
ClinicalTrials.gov Identifier:
NCT00318851
First received: April 25, 2006
Last updated: August 25, 2010
Last verified: March 2006
History of Changes
  Purpose

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


Condition Intervention Phase
Carotid Artery Stenosis
 Device: Carotid Stent with Distal Protection Device
 Phase 3

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

Further study details as provided by Providence Health & Services:

Primary Outcome Measures:
  • Number of new diffusion weighted abnormalities post-procedure [ Time Frame: 24 hours post stent placement ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Neuropsychological stability or deterioration [ Time Frame: 3 months post procedure ] [ Designated as safety issue: No ]
  • Neuropsychological stability or deterioration [ Time Frame: 6 months post procedure ] [ Designated as safety issue: No ]
  • Neuropsychological stability or deterioration [ Time Frame: 12 months post procedure ] [ Designated as safety issue: No ]
  • Acute versus delayed neuropsychological changes [ Time Frame: 1-7 days post procedure ] [ Designated as safety issue: No ]
  • Acute versus delayed neuropsychological changes [ Time Frame: 3 months post procedure ] [ Designated as safety issue: No ]
  • Acute versus delayed neuropsychological changes [ Time Frame: 6 months post procedure ] [ Designated as safety issue: No ]
  • Acute versus delayed neuropsychological changes [ Time Frame: 12 months post procedure ] [ Designated as safety issue: No ]
  • Stroke and death [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • Stroke and death [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Stroke and death [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • NIH stroke scale changes [ Time Frame: 24 hours post procedure ] [ Designated as safety issue: No ]
  • NIH stroke scale changes [ Time Frame: 1 month post procedure ] [ Designated as safety issue: No ]
  • NIH stroke scale changes [ Time Frame: 6 months post procedure ] [ Designated as safety issue: No ]
  • NIH stroke scale changes [ Time Frame: 12 months post procedure ] [ Designated as safety issue: No ]

Enrollment: 62
Study Start Date: September 2003
Study Completion Date: August 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00318851

Locations
United States, Washington
Sacred Heart Medical Center
Spokane, Washington, United States, 99204
Sponsors and Collaborators
Providence Health & Services
Investigators
Principal Investigator: Rodney D. Raabe, MD Providence Health & Services
  More Information

Additional Information:
(Click here for more information regarding Providence Medical Research Center)  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Rodney D. Raabe, MD, Providence Sacred Heart Medical Center & Children's Hospital
ClinicalTrials.gov Identifier: NCT00318851     History of Changes
Other Study ID Numbers: HI473
Study First Received: April 25, 2006
Last Updated: August 25, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Providence Health & Services:
Carotid Artery stenting
Stroke

Additional relevant MeSH terms:
Carotid Stenosis
Constriction, Pathologic
Carotid Artery Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on May 21, 2013