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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

April 25, 2006
August 25, 2010
September 2003
August 2007   (final data collection date for primary outcome measure)
Number of new diffusion weighted abnormalities post-procedure [ Time Frame: 24 hours post stent placement ] [ Designated as safety issue: No ]
  • Number of new diffusion weighted abnormalities post-procedure
  • Neuropsychological stability or deterioration
  • Acute (1-7 days)versus delayed (3,6, 12 month) neuropsychological changes\
Complete list of historical versions of study NCT00318851 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Stroke and death at 1 month, 6 months, and 12 months
  • NIH stroke scale changes at 24 hours, 1 month, 6 months and 12 months
Not Provided
Not Provided
 
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.

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.

Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Carotid Artery Stenosis
Device: Carotid Stent with Distal Protection Device
Carotid Stent Placement with Distal Protection
Other Names:
  • Carotid Artery Stenting
  • Neurocognitive evaluation in Carotid Artery Stenting
Experimental: Carotid Artery Stenting
Intervention: Device: Carotid Stent with Distal Protection Device
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
62
August 2007
August 2007   (final data collection date for primary outcome measure)

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
Both
18 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00318851
HI473
No
Rodney D. Raabe, MD, Providence Sacred Heart Medical Center & Children's Hospital
Providence Health & Services
Not Provided
Principal Investigator: Rodney D. Raabe, MD Providence Health & Services
Providence Health & Services
March 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP