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

• ClinicalTrials.gov Identifier: NCT00287508
• Recruitment Status: Completed
• First Posted: February 7, 2006
• Last Update Posted: October 17, 2008
• Sponsor: Abbott Medical Devices
• Information provided by: Abbott Medical Devices

Tracking Information

• First Submitted Date: February 1, 2006
• First Posted Date: February 7, 2006
• Last Update Posted Date: October 17, 2008
• Study Start Date: November 2005
• Actual Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 2, 2006)

• 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).

Original Primary Outcome Measures (submitted: February 3, 2006)

• · 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).

• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Emboshield® and Xact® Post Approval Carotid Stent Trial (The EXACT 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
• 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).

• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label)

Condition

• Carotid Artery Disease
• Carotid Stenosis
• Stroke
• Atherosclerosis

• Intervention: Device: Carotid artery stenting with filter (interventional)
• Study Arms: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Enrollment (submitted: February 3, 2006): 1500
• Original Enrollment: Same as current
• Actual Study Completion Date: January 2008
• Actual Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: Child, Adult, Older Adult
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided
• Removed Location Countries: United States

Administrative Information

• NCT Number: NCT00287508
• Other Study ID Numbers: AVD-640-0063
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Matt Kiely, Manager Medical Information, Abbott Vascular
• Study Sponsor: Abbott Medical Devices
• Collaborators: Not Provided

Investigators

• Study Chair: Don E Schwarten, MD; Abbott Medical Devices

• PRS Account: Abbott Medical Devices
• Verification Date: October 2008