NCT00287508

Brief Summary

To collect clinical outcome and device performance data on the FDA 510(k)-cleared Emboshield® BareWire™ Rapid Exchange Embolic Protection System and FDA-approved Xact® Rapid Exchange Carotid Stent System when used under commercial use conditions by a broad group of physicians entering the study with differing carotid artery stenting experiences.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
1,500

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Nov 2005

Typical duration for phase_4

Status
completed

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

November 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 1, 2006

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 7, 2006

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
Last Updated

October 17, 2008

Status Verified

October 1, 2008

Enrollment Period

2.1 years

First QC Date

February 1, 2006

Last Update Submit

October 16, 2008

Conditions

Carotid Artery DiseaseCarotid StenosisStrokeAtherosclerosis

Keywords

Carotid stentingCarotid endarterectomyCarotid artery disease with severe narrowing of the arteryStroke preventioncerebral infarction

Outcome Measures

Primary Outcomes (2)

  • The endpoint for the 1500 subjects enrolled will be a 30-day composite of death, stroke and myocardial infarction (MI).

  • For the 500 subjects with 12 month follow-up, the endpoint will be a composite of stroke, death and MI at 30 days and ipsilateral stroke at 12 months (31-365 days).

Interventions

Carotid artery stenting with filter (interventional)DEVICE

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects who agree to participate in this study and have signed the IRB approved informed consent form.
  • Subjects who are willing to have the Emboshield and/or the Xact inserted into the their vasculature.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Carotid Artery DiseasesCarotid StenosisStrokeAtherosclerosisCerebral Infarction

Interventions

Methods

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesArterial Occlusive DiseasesArteriosclerosisBrain InfarctionBrain IschemiaInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • Don E Schwarten, MD

    Abbott Medical Devices

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 1, 2006

First Posted

February 7, 2006

Study Start

November 1, 2005

Primary Completion

December 1, 2007

Study Completion

January 1, 2008

Last Updated

October 17, 2008

Record last verified: 2008-10