In January 2005, the oversight responsibility of the Post-Approval Studies Program was transferred to the Division of Epidemiology (DEPI) of the Office of Surveillance and Biometrics (OSB)/Center for Devices and Radiological Health (CDRH).
The CDRH Post-Approval Studies Program encompasses design, tracking, oversight, and review responsibilities for studies mandated as a condition of approval of a premarket approval (PMA) application, protocol development product (PDP) application, or humanitarian device exemption (HDE) application. The program helps ensure that well-designed post-approval studies (PAS) are conducted effectively and efficiently and in the least burdensome manner.
CDRH has established an automated, internal tracking system that efficiently identifies the reporting status of active PAS studies ordered since January 1, 2005 based on study timelines incorporated in study protocols and agreed upon by the CDRH and applicants. This system represents CDRH's effort to ensure that all PAS commitments are fulfilled in a timely manner.
In addition, CDRH launched this publicly available webpage to keep all stakeholders informed of the progress of each PAS. The webpage displays general information regarding each PAS, as well as the overall study status (based on protocol-driven timelines and the adequacy of the data) and the applicant's reporting status for each submission due.
Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v
Silver Spring, MD
20993-0002
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.
Followup Visits and Length of Followup
Patients were followed for 1-year. The endpoint of DSMI at 30 days and ipsilateral stroke
between days 31 and 365.
Final Study Results
Actual Number of Patients Enrolled
2232 patietns
Actual Number of Sites Enrolled
128 sites
Patient Followup Rate
85%
Final Safety Findings
The composite event rate in the EXACT study (death, stroke, and myocardial infarction) of 4.1%
at 30 days. This is less then that event rate reported in the pivotal SECURITY trial (7.5%). The composite one-year endpoint rate wasf 6.1%.
Study Strengths and Weaknesses
Strengths: The sponsor was able to achieve a greater than 90% follow up rate at
3 years. Weaknesses: There was no control group in this study.
Recommendations for Labeling Changes
Updated labeling requested from sponsor to reflect myocardial infarction and stroke rates at 3 years.
