Emboshield® and Xact® Post Approval Carotid Stent Trial (The EXACT Study) - Full Text View

Sponsor:	Abbott Vascular
Information provided by:	Abbott Vascular
ClinicalTrials.gov Identifier:	NCT00287508

Purpose

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.

Condition	Intervention	Phase
Carotid Artery Disease Carotid Stenosis Stroke Atherosclerosis	Device: Carotid artery stenting with filter (interventional)	Phase IV

Study Type:	Interventional
Study Design:	Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official 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

Resource links provided by NLM:

MedlinePlus related topics: Carotid Artery Disease

U.S. FDA Resources

Further study details as provided by Abbott Vascular:

Primary Outcome Measures:

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).

Estimated Enrollment:	1500
Study Start Date:	November 2005
Study Completion Date:	January 2008
Primary Completion Date:	December 2007 (Final data collection date for primary outcome measure)

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).

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00287508

Sponsors and Collaborators

Abbott Vascular

Investigators

Study Chair:

Don E Schwarten, MD

Abbott Vascular

More Information

No publications provided

Responsible Party:	Abbott Vascular ( Matt Kiely, Manager Medical Information )
Study ID Numbers:	AVD-640-0063
Study First Received:	February 1, 2006
Last Updated:	October 16, 2008
ClinicalTrials.gov Identifier:	NCT00287508 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Abbott Vascular:

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

Additional relevant MeSH terms:

Arterial Occlusive Diseases
Atherosclerosis
Carotid Stenosis
Nervous System Diseases
Stroke
Vascular Diseases

Central Nervous System Diseases
Cardiovascular Diseases
Arteriosclerosis
Brain Diseases
Carotid Artery Diseases
Cerebrovascular Disorders

ClinicalTrials.gov processed this record on February 08, 2010