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Carotid Artery Stenting With Protection Registry

Primary Purpose

Carotid Artery Stenosis

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Carotid Stent with Distal Protection Device
Sponsored by
Providence Health & Services
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carotid Artery Stenosis focused on measuring Carotid Artery stenting, Stroke

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Sacred Heart Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Carotid Artery Stenting

Arm Description

Outcomes

Primary Outcome Measures

Number of new diffusion weighted abnormalities post-procedure

Secondary Outcome Measures

Neuropsychological stability or deterioration
Neuropsychological stability or deterioration
Neuropsychological stability or deterioration
Acute versus delayed neuropsychological changes
Acute versus delayed neuropsychological changes
Acute versus delayed neuropsychological changes
Acute versus delayed neuropsychological changes
Stroke and death
Stroke and death
Stroke and death
NIH stroke scale changes
NIH stroke scale changes
NIH stroke scale changes
NIH stroke scale changes

Full Information

First Posted
April 25, 2006
Last Updated
August 25, 2010
Sponsor
Providence Health & Services
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1. Study Identification

Unique Protocol Identification Number
NCT00318851
Brief Title
Carotid Artery Stenting With Protection Registry
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2006
Overall Recruitment Status
Completed
Study Start Date
September 2003 (undefined)
Primary Completion Date
August 2007 (Actual)
Study Completion Date
August 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Providence Health & Services

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carotid Artery Stenosis
Keywords
Carotid Artery stenting, Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Carotid Artery Stenting
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Carotid Stent with Distal Protection Device
Other Intervention Name(s)
Carotid Artery Stenting, Neurocognitive evaluation in Carotid Artery Stenting
Intervention Description
Carotid Stent Placement with Distal Protection
Primary Outcome Measure Information:
Title
Number of new diffusion weighted abnormalities post-procedure
Time Frame
24 hours post stent placement
Secondary Outcome Measure Information:
Title
Neuropsychological stability or deterioration
Time Frame
3 months post procedure
Title
Neuropsychological stability or deterioration
Time Frame
6 months post procedure
Title
Neuropsychological stability or deterioration
Time Frame
12 months post procedure
Title
Acute versus delayed neuropsychological changes
Time Frame
1-7 days post procedure
Title
Acute versus delayed neuropsychological changes
Time Frame
3 months post procedure
Title
Acute versus delayed neuropsychological changes
Time Frame
6 months post procedure
Title
Acute versus delayed neuropsychological changes
Time Frame
12 months post procedure
Title
Stroke and death
Time Frame
1 month
Title
Stroke and death
Time Frame
6 months
Title
Stroke and death
Time Frame
12 months
Title
NIH stroke scale changes
Time Frame
24 hours post procedure
Title
NIH stroke scale changes
Time Frame
1 month post procedure
Title
NIH stroke scale changes
Time Frame
6 months post procedure
Title
NIH stroke scale changes
Time Frame
12 months post procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rodney D. Raabe, MD
Organizational Affiliation
Providence Health & Services
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sacred Heart Medical Center
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States

12. IPD Sharing Statement

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Carotid Artery Stenting With Protection Registry

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