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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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ODE Lead-Cont f/u ANCHOR Reg Short Neck Cohort


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General
Study Status Progress Adequate
Application Number P100021 S063/ PAS001
Date Current Protocol Accepted  
Study Name ODE Lead-Cont f/u ANCHOR Reg Short Neck Cohort
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 This study consists of the extended follow-up data out to 5 years for surviving patients enrolled in the ANCHOR Registry Short Neck Cohort.
Study Population Description Patients with an abdominal aortic aneurysm with an infrarenal neck length measured as greater than or equal to 4 to <10mm by the core laboratory, who met the selection criteria and who were treated with an Endurant or Endurant II/IIs Stent Graft System and the Heli-FX EndoAnchor System during the initial repair of their aneurysm.
Sample Size 70 patients were enrolled in Short Neck Cohort. Follow-up data on the surviving patients in this cohort will be reported in this PAS.
Data Collection Clinical outcomes will include aneurysm-related mortality, aneurysm rupture, aneurysm expansion, Type Ia endoleak, migration, Type III endoleak, re-intervention, device-related adverse events, and device integrity.
Follow-up Visits and Length of Follow-up 5 years


ODE Lead-Cont f/u ANCHOR Reg Short Neck Cohort Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
one year report 09/29/2018    
two year report 09/29/2019    
three year report 09/28/2020    
four year report 09/28/2021    
five year report 09/28/2022    


Contact Us

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD
20993-0002

Phone: (301) 796-6134
Fax: (301) 847-8140
julie.unger@fda.hhs.gov

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