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U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

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The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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Study Status Completed
Application Number P040038 / PAS002
Date Current Protocol Accepted 10/12/2005
Study Name EXACT Study
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source Sponsor Registry
Comparison Group Concurrent Control
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description The objective of the EXACT study is to collect clinical outcome and device performance data on the Xact

Rapid Exchange Carotid Stent System when used in conjunction with the emboshield.Bare Wire Rapid Exchange Embolic Protection System, in general use, to identify any rare adverse or unanticipated device related events and to determine the adequacy of the Abbott training program.
Study Population Description This device is indicated for the improvement of the lumen diameter of carotid arteries in patients considered at high risk for adverse events from carotid endarterectomy who require percutaneous carotid angioplasty and stenting for occlusive artery disease and meet the criteria outlined as follows:1) Patients with carotid artery stenosis (>50% for symptomatic patients by ultrasound or angiography or >80% for asymptomatic patients by ultrasound or angiography), located between the origin of the common carotid artery and the intra-cranial segment of the internal carotid artery; and 20 Patients must have a reference vessel diameter ranging between 4.8 mm and 9.1 mm at the target lesion.
Sample Size 1500 patients, 150 sites
Data Collection There are two primary composite endpoints defined in this study. The first primary composite endpoint includes the 30-day follow-up composite rate of death, stroke, and myocardial infarction at 30 days post-procedure for all subjects. The second primary endpoint included the subset of patients to be followed for 1-year where the primary composite endpoint is a composite of stroke, death and myocardial infarction at 30 days and ipsilateral stroke at 1 year.
Follow-up Visits and Length of Follow-up Patients were followed for 1-year. The endpoint of DSMI at 30 days and ipsilateral stroke between days 31 and 365.

EXACT Study Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
Final EXACT Report 06/30/2008 06/27/2008 On Time

Contact Us

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD

Phone: (301) 796-6134
Fax: (301) 847-8140

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