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

Stroke Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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). ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Atherosclerosis
• Carotid Artery Disease
• Carotid Artery Diseases
• Carotid Stenosis
• Stroke

• NCT number: NCT00287508
• Study type: Interventional
• Source: Abbott Vascular
• Status: Completed
• Phase: Phase 4
• Start date: November 2005
• Completion date: January 2008