Emboshield® and Xact® Post Approval Carotid Stent Trial (The EXACT Study)

Emboshield and Xact Post Approval Carotid Stent Trial Using the Emboshield® BareWire™ Rapid Exchange Embolic Protection System and Xact® Rapid Exchange Carotid Stent System

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00287508

Enrollment

1500

Registered

2006-02-07

Start date

2005-11-30

Completion date

2008-01-31

Last updated

2008-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atherosclerosis, Carotid Artery Disease, Carotid Stenosis, Stroke

Keywords

Carotid stenting, Carotid endarterectomy, Carotid artery disease with severe narrowing of the artery, Stroke prevention, cerebral infarction

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.

Detailed description

This is a multi-center, observational, single arm, post-approval study enrolling the following study population: * Subjects with neurological symptoms and \>= 50% stenosis of the common or internal carotid artery by ultrasound or angiogram (visual estimate), or * Subjects without neurological symptoms and \>= 80% stenosis of the common or internal carotid artery by ultrasound or angiogram (visual estimate) * 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

DEVICECarotid artery stenting with filter (interventional)

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Masking

NONE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

* 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.

Exclusion criteria

* There are no

Design outcomes

Primary

Measure	Time frame
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).	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026