NCT01550835

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

March 1, 2012

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 12, 2012

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
Last Updated

April 21, 2015

Status Verified

April 1, 2015

Enrollment Period

4 years

First QC Date

March 1, 2012

Last Update Submit

April 17, 2015

Conditions

Carotid Artery Stenosis

Keywords

Symptomatic carotid artery stenosis

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • Ischemic zone area

    18-48 hours post stenting

Study Arms (2)

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

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

Standard of care use of an embolic protection device

Distal Embolic Protection Only

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

El Camino Hospital

Mountain View, California, 94040, United States

RECRUITING

Northern Michigan Regional Hospital

Petoskey, Michigan, 49770, United States

RECRUITING

MeSH Terms

Conditions

Carotid Stenosis

Condition Hierarchy (Ancestors)

Carotid Artery DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesArterial Occlusive DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • James Joye, DO

    Fogarty Clinical Research Inc.

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Betty deBettencourt, RN

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief Medical Officer

Study Record Dates

First Submitted

March 1, 2012

First Posted

March 12, 2012

Study Start

February 1, 2012

Primary Completion

February 1, 2016

Last Updated

April 21, 2015

Record last verified: 2015-04

Locations

US(2)