Recruiting

Aspiration Thrombectomy

Sponsor:

Fogarty Clinical Research Inc.

Code:

NCT01550835

Conditions

Carotid Artery Stenosis

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

Interventions

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

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

Study Details

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.

Conditions

Carotid Artery Stenosis

Study ID

NCT01550835

Start date

Feb, 2012

Status verified date

Apr, 2015

Primary completion date

Feb, 2016

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Distal Embolic Protection Only

Carotid stenting with distal embolic protection only

active comparator: Distal embolic protection and aspiration thrombectomy

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

Interventions

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

Standard of care use of an embolic protection device

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

Aspiration thrombectomy following stent deployment and prior to embolic protection device removal

Primary outcome measure

  • Number of new, ischemic foci [ Time Frame: 18-48 hours post procedure ]

Central Contacts and Locations

Central contacts

Betty deBettencourt, RN

650-962-4566betty.debettencourt@fogartyinstitute.org

Locations

El Camino Hospital

Recruiting

Mountain View, California, United States, 94040

Contacts

Betty deBettencourt, RN

650-962-4566betty.debettencourt@fogartyinstitute.org

Principal Investigator:

James Joye, DO

Northern Michigan Regional Hospital

Recruiting

Petoskey, Michigan, United States, 49770

Contacts

Jennifer Lalonde, RN

231-487-9185jlalonde@cvrcnm.com

Principal Investigator:

Jason Ricci, MD

More Information

Sponsor

Fogarty Clinical Research Inc.

Last update posted

Apr 21, 2015

Last verified

Apr, 2015

Keywords

  • Symptomatic carotid artery stenosis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Fogarty Clinical Research Inc. on 2015-04-21.