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Impact of Aspiration Thrombectomy During Carotid Stenting

Primary Purpose

Carotid Artery Stenosis

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Emboshield NAV6® embolic protection system (Abbott Vascular, Santa Clara, CA)
Emboshield NAV6® embolic protection system (Abbott Vascular, Santa Clara, CA)
Sponsored by
Fogarty Clinical Research Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carotid Artery Stenosis focused on measuring Symptomatic carotid artery stenosis

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • ICA stenosis greater than 50 percent by carotid angiography
  • Documented hemispheric ischemic stroke, TIA, amaurosis fugax, or retinal stroke in the last six months ipsilateral to the stented lesion

Exclusion Criteria:

  • Subject less than 40 years of age
  • Pregnant subjects
  • Asymptomatic carotid stenosis
  • Total occlusion of target carotid artery
  • Inability to deploy distal protection device or stent in target vessel
  • Allergy to both aspirin and approved thienopyridine anti-platelet drugs (clopidogrel/ticlopidine)
  • Multiple carotid stenoses in same vessel that cannot be covered by single stent
  • Ipsilateral intracranial stenosis requiring treatment
  • Isolated common carotid stenosis
  • Stenosis less than 50 percent by angiography
  • Chronic or paroxysmal atrial fibrillation not treated with warfarin or dabigatran.
  • Life expectancy less than 30 days
  • Active bleeding diathesis
  • Suspected Myocardial Infarction within 72 hours prior to carotid stenting
  • Presence of intracranial tumor arteriovenous malformations or aneurysm requiring treatment
  • Inability to undergo DWMRI
  • Unwillingness to participate or provide consent
  • Subjects using a legally authorized representative for consent for participation
  • Concurrently enrolled in another study
  • Stroke, TIA, amaurosis fugax ipsilateral to the treated lesion more than 6 months from randomization
  • Occlusive or critical ilio-femoral disease that precludes safe femoral access to the aortic arch
  • Severe atherosclerosis of the aortic arch or origin of the innominate or common carotid arteries
  • Prior large stroke, multiple lacunar infarcts, or dementia
  • Stenosis that contain visible thrombus

Sites / Locations

  • El Camino HospitalRecruiting
  • Northern Michigan Regional HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Distal Embolic Protection Only

Distal embolic protection and aspiration thrombectomy

Arm Description

Carotid stenting with distal embolic protection only

Aspiration thrombectomy following stent deployment and prior to removal of distal embolic protection

Outcomes

Primary Outcome Measures

Number of new, ischemic foci
Foci of restricted diffusion will be classified by their number, location, and size

Secondary Outcome Measures

Ischemic zone area
Maximum size of new, ipsilateral,ischemic foci on post-carotid stenting diffusion-weighted MRI of the brain

Full Information

First Posted
March 1, 2012
Last Updated
April 17, 2015
Sponsor
Fogarty Clinical Research Inc.
Collaborators
Abbott Medical Devices, Helen Kay Foundation, Northern Michigan Hospital Foundation's Louis A. and Sally Cannon
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1. Study Identification

Unique Protocol Identification Number
NCT01550835
Brief Title
Impact of Aspiration Thrombectomy During Carotid Stenting
Official Title
Impact of Aspiration Thrombectomy During Carotid Stenting on New Ischemic Lesions Identified by Diffusion-Weighted Magnetic Resonance Imaging
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Unknown status
Study Start Date
February 2012 (undefined)
Primary Completion Date
February 2016 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fogarty Clinical Research Inc.
Collaborators
Abbott Medical Devices, Helen Kay Foundation, Northern Michigan Hospital Foundation's Louis A. and Sally Cannon

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to determine whether aspiration thrombectomy following carotid stent deployment will reduce the number of procedure related signals as identified by diffusion weighted MRI of the brain.
Detailed Description
Studies have demonstrated that carotid artery stenting is a safe and effective alternative to carotid endarterectomy for high or standard risk patients with symptomatic stenosis. Despite the routine use of embolic protection devices, numerous studies have shown that carotid stenting is associated with a higher degree of intracranial emboli by diffusion-weighted MRI of the brain. A potential solution to minimize this effect is the use of aspiration prior to distal embolic protection removal.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carotid Artery Stenosis
Keywords
Symptomatic carotid artery stenosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Distal Embolic Protection Only
Arm Type
Experimental
Arm Description
Carotid stenting with distal embolic protection only
Arm Title
Distal embolic protection and aspiration thrombectomy
Arm Type
Active Comparator
Arm Description
Aspiration thrombectomy following stent deployment and prior to removal of distal embolic protection
Intervention Type
Device
Intervention Name(s)
Emboshield NAV6® embolic protection system (Abbott Vascular, Santa Clara, CA)
Intervention Description
Standard of care use of an embolic protection device
Intervention Type
Device
Intervention Name(s)
Emboshield NAV6® embolic protection system (Abbott Vascular, Santa Clara, CA)
Intervention Description
Aspiration thrombectomy following stent deployment and prior to embolic protection device removal
Primary Outcome Measure Information:
Title
Number of new, ischemic foci
Description
Foci of restricted diffusion will be classified by their number, location, and size
Time Frame
18-48 hours post procedure
Secondary Outcome Measure Information:
Title
Ischemic zone area
Description
Maximum size of new, ipsilateral,ischemic foci on post-carotid stenting diffusion-weighted MRI of the brain
Time Frame
18-48 hours post stenting

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ICA stenosis greater than 50 percent by carotid angiography Documented hemispheric ischemic stroke, TIA, amaurosis fugax, or retinal stroke in the last six months ipsilateral to the stented lesion Exclusion Criteria: Subject less than 40 years of age Pregnant subjects Asymptomatic carotid stenosis Total occlusion of target carotid artery Inability to deploy distal protection device or stent in target vessel Allergy to both aspirin and approved thienopyridine anti-platelet drugs (clopidogrel/ticlopidine) Multiple carotid stenoses in same vessel that cannot be covered by single stent Ipsilateral intracranial stenosis requiring treatment Isolated common carotid stenosis Stenosis less than 50 percent by angiography Chronic or paroxysmal atrial fibrillation not treated with warfarin or dabigatran. Life expectancy less than 30 days Active bleeding diathesis Suspected Myocardial Infarction within 72 hours prior to carotid stenting Presence of intracranial tumor arteriovenous malformations or aneurysm requiring treatment Inability to undergo DWMRI Unwillingness to participate or provide consent Subjects using a legally authorized representative for consent for participation Concurrently enrolled in another study Stroke, TIA, amaurosis fugax ipsilateral to the treated lesion more than 6 months from randomization Occlusive or critical ilio-femoral disease that precludes safe femoral access to the aortic arch Severe atherosclerosis of the aortic arch or origin of the innominate or common carotid arteries Prior large stroke, multiple lacunar infarcts, or dementia Stenosis that contain visible thrombus
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Betty deBettencourt, RN
Phone
650-962-4566
Email
betty.debettencourt@fogartyinstitute.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Joye, DO
Organizational Affiliation
Fogarty Clinical Research Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
El Camino Hospital
City
Mountain View
State/Province
California
ZIP/Postal Code
94040
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Betty deBettencourt, RN
Phone
650-962-4566
Email
betty.debettencourt@fogartyinstitute.org
First Name & Middle Initial & Last Name & Degree
James Joye, DO
Facility Name
Northern Michigan Regional Hospital
City
Petoskey
State/Province
Michigan
ZIP/Postal Code
49770
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer Lalonde, RN
Phone
231-487-9185
Email
jlalonde@cvrcnm.com
First Name & Middle Initial & Last Name & Degree
Jason Ricci, MD

12. IPD Sharing Statement

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Impact of Aspiration Thrombectomy During Carotid Stenting

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