Impact of Aspiration Thrombectomy During Carotid Stenting | NCT01550835

Studies
Impact of Aspiration Thrombectomy During Carotid Stenting

NCT01550835

Sponsor

Fogarty Clinical Research Inc.

Status

Unknown status

Last Update Posted

Apr 21, 2015Estimated

Enrollment

80Estimated

Phase

Not Applicable

Conditions

Carotid Artery Stenosis

Interventions

Emboshield NAV6® embolic protection system (Abbott Vascular, Santa Clara, CA)
Emboshield NAV6® embolic protection system (Abbott Vascular, Santa Clara, CA)

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2012

Primary Completion Date

Feb 2016Estimated

Completion Date

Not provided

First Submitted Date

Mar 1, 2012

First Submission Date that Met QC Criteria

Mar 7, 2012

First Posted Date

Mar 12, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 17, 2015

Last Update Posted Date

Apr 21, 2015Estimated

Name	Class
Abbott Medical Devices	INDUSTRY
Helen Kay Foundation	UNKNOWN
Northern Michigan Hospital Foundation's Louis A. and Sally Cannon	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

80Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Distal Embolic Protection Only	Experimental	Carotid stenting with distal embolic protection only	Device: Emboshield NAV6® embolic protection system (Abbott Vascular, Santa Clara, CA)
Distal embolic protection and aspiration thrombectomy	Active Comparator	Aspiration thrombectomy following stent deployment and prior to removal of distal embolic protection	Device: Emboshield NAV6® embolic protection system (Abbott Vascular, Santa Clara, CA)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Emboshield NAV6® embolic protection system (Abbott Vascular, Santa Clara, CA)	Device	Standard of care use of an embolic protection device	Distal Embolic Protection Only

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of new, ischemic foci	Foci of restricted diffusion will be classified by their number, location, and size	18-48 hours post procedure

Secondary Outcomes

Measure	Description	Time Frame
Ischemic zone area	Maximum size of new, ipsilateral,ischemic foci on post-carotid stenting diffusion-weighted MRI of the brain	18-48 hours post stenting

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D002340	Carotid Artery Diseases
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases