• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

  • Print
  • Share
  • E-mail

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) approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

Learn more...



Suggest Enhancement / Report Issue | export reports to excelExport to Excel
Application Number P050019 / PAS002
Current Plan Approved 10/23/2008
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source Sponsor Registry
Comparison Group Historical Control
Analysis Type Descriptive
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description The BEACH Trial was a prospective, single-arm, multi-center trial intended to evaluate the safety and effectiveness of the Boston Scientific Corporation (BSC) Carotid WALLSTENT Endoprosthesis in conjunction with the FilterWire EX/EZ System in selected high-risk surgical patients with stenosis of the carotid artery. Success of this trial was assessed by comparison to an OPC representative of similar patients treated with CEA. A maximum of six hundred eighty (680) patients with carotid stenosis at high risk for complications associated with CEA who met specific enrollment criteria were to be evaluated in the Pivotal portion of the trial and a maximum of 96 for the Bilateral Registry. Clinical follow-up for all patients was planned to occur at 1 month, 6 month, and 12 months and annually thereafter up to 60 months post index procedure. Preliminary examinations included angiography, ultrasound, and computed tomography (CT) or magnetic resonance imaging (MRI). The procedural evaluation included baseline angiography. Follow-up examinations included carotid duplex ultrasound imaging. If for any reason carotid ultrasound was not possible, an angiographic examination was required. A complete lab study was performed after the patient qualified for entry into the clinical trial.
Study Population Description The Carotid WALLSTENT Monorail Endoprosthesis, used in conjunction with the Boston Scientific embolic protection system, is indicated for the treatment of patients at high risk for adverse events from carotid endarterectomy due to either anatomic or co-morbid conditions who require carotid revascularization in the treatment of ipsilateral or bilateral carotid artery disease.
Sample Size 747 patients, 47 sites
Data Collection The primary endpoint (defined as the composite of Non Q-wave myocardial infarction within the 24 hours following carotid stenting; death, stroke and Q-wave myocardial infarction within 30 days; and ipsilateral stroke or death due to neurological events from 31 days to one year) was compared to the weighted performance criteria.
Follow-up Visits and Length of Follow-up Patients will be assessed at 30 days, and annually to 3 years.
Final Study Results
Interim Safety Information Study completed, see final results.
Number of Patients 747 patients
Number of Sites 47 sites
Follow-up Rate 90%
Safety Findings The 3 year death, stroke and myocsrdial infarction rates were 5.6%, 2.3%, and 0.3%. These rates declined from their peaks which were seen at one year: 7.7%, 8.3%, and 2.6% respectively.
Strengths & Weaknesses Strengths: The sponsor did complete this study within a reasonable period of time (2 years after device approval), eventhough there was not a study timeline. Weaknesses: The sponsor notes that 315 of the 480 patients were evaluable at 3 years. There were 84 deaths in the study. If the deaths are not included in the lost-to-follow-up rate than the 3 year follow-up was 83% (399/480). This is lower than would be expected for an IDE study however, it is an acceptable rate.
Label Changes Labeling changes were not recommended.


Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
FINAL Report 04/23/2009 04/22/2009 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

Related Links