NCT00287508

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
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,500 (planned)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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).

Conditions

• Carotid Artery Disease
• Carotid Stenosis
• Stroke
• Atherosclerosis

Interventions

Type	Name	Description
DEVICE	Carotid artery stenting with filter (interventional)

Timeline

• Start date: 2005-11-01
• Primary completion: 2007-12-01
• Completion: 2008-01-01
• First posted: 2006-02-07
• Last updated: 2008-10-17