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U.S. Department of Health and Human Services

522 Postmarket Surveillance Studies

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CENTER FOR DEVICES AND RADIOLOGICAL HEALTH

DIVISION OF EPIDEMIOLOGY

"PROTECTING & PROMOTING PUBLIC HEALTH THROUGH DEVICE SURVEILLANCE AND RESEARCH"



WELCOME TO THE 522 POSTMARKET SURVEILLANCE STUDIES WEBPAGE

 

 

 

 

            

Rates of Stroke and Death


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General
522 Number / Requirement Number PS120110 / PSS001
Current Plan Approved 06/17/2013
Study Name Rates of Stroke and Death
Root Document Number H050001 
General Study Protocol Parameters
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description a prospective, single-arm study of the Wingspan Stent System and Gateway PTA Balloon Catheter.

Study Population Description The study population will consist of adult patients who have a Wingspan stent procedure attempted

Sample Size Approximately 389 subjects will be required to obtain 350 subjects eligible for the primary analysis at a maximum of 50 sites (US or International) is planned. Enrollment rate is expected to be between 75 and 250 patients per year. Minimum number of US or International sites: 30 sites. Minimum number of US sites: 25 sites.

Data Collection The primary endpoint is the rate of stroke or death within 72 hours of the procedure. Secondary endpoints include the following: Hemorrhagic stroke within 72 hours post procedure: Ischemic stroke within 72 hours post procedure: Neurological death within 72 hours post procedure: Stroke recovery at 90 days post procedure: Stroke in the territory of the stented artery within 72 hours post procedure

Follow-up Visits and Length of Follow-up 72 hours Post Procedure. Day 4 Post Procedure. Post Stroke Follow-Up: Patients who receive a stent and have a stroke within 72 hours post procedure will be followed for 90 days, at stroke onset, day 3, and day 90.



Rates of Stroke and Death Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 12/17/2013 12/13/2013 On Time
one year report 06/17/2014 06/16/2014 On Time
18 month report 12/17/2014 12/18/2014 Overdue/Received
two year report 06/17/2015 06/23/2015 On Time
three year report 06/17/2016    
four year report 06/17/2017    


  • The 522 Postmarket Surveillance Studies Program encompasses design, tracking, oversight, and review responsibilities for studies mandated under section 522 of the Federal Food, Drug and Cosmetic Act. The program helps ensure that well-designed 522 postmarket surveillance (PS) studies are conducted effectively and efficiently and in the least burdensome manner.
  • In May 2008, the oversight responsibility of the 522 Postmarket Surveillance 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). DEPI continues to build the 522 program.
  • CDRH has established an automated internal tracking system that efficiently identifies the reporting status of active 522 PS studies 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 522 PS 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 522 PS study. The webpage displays general information regarding each study, as well as the overall study status (based on protocol-driven timelines and adequacy of the data) and the applicant's reporting status for each submission due.

Links

Contact Information

Cheryl Reynolds
Project Manager, 522 Postmarket Surveillance (PS) Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4108
Silver Spring, MD 20993-0002

Phone: (301) 796-7033
Fax: (301) 847-8140
Cheryl.Reynolds@fda.hhs.gov
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