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

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.

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Key information

Conditions

Carotid Artery Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Brain Diseases Brain Infarction Brain Ischemia Cardiovascular Diseases Carotid Artery Diseases Carotid Stenosis Central Nervous System Diseases Cerebral Infarction Cerebrovascular Disorders Infarction Ischemia Necrosis Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Stroke Vascular Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 exclusion criteria for this study.

Treatment and study plan

Carotid artery stenting with filter (interventional)

Device

Primary outcomes

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).

Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Registry information

Official study title

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

Important dates

Study start: 2005
Primary completion: 2007
Study completion: 2008
First posted: Feb 7, 2006
Registry last updated: Oct 17, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed