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U.S. Department of Health and Human Services

Post-Approval Studies (PAS) Database
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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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Cont f/u ANCHOR Reg Short Neck Cohort


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General
Study Status Ongoing
Application Number /
Requirement Number		 P100021 S063/ PAS001
Date Original Protocol Accepted 09/29/2017
Date Current Protocol Accepted 05/28/2021
Study Name Cont f/u ANCHOR Reg Short Neck Cohort
Device Name Endurant II/IIs Stent Graft System
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 Objectives The purpose of this study is to evaluate the long-term safety and effectiveness outcomes on the use of the Endurant II/IIs Stent Graft System to treat short neck infrarenal abdominal aortic aneurysms when used in conjunction with the Heli-FX EndoAnchor System. The study was originally approved with enrollment of 70 subjects to be followed for up to 5 years. Clinical safety and effectiveness outcomes from the 70 subjects were used to seek an indication expansion for the Endurant II/IIs Stent Graft System to treat short (proximal neck lengths greater than or equal to 4 mm and < 10 mm) neck infrarenal abdominal aortic aneurysms when used in conjunction with the Heli-FX EndoAnchor System. In May 2021, FDA approved a study expansion to include clinical data for 60 additional core lab-verified short neck subjects from the ANCHOR registry to support the long-term safety and effectiveness for the short neck indication. These additional 60 subjects will be followed through 5 years as per the ANCHOR clinical investigation plan requirements.
Study Population 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.
Key Study Endpoints 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


Cont f/u ANCHOR Reg Short Neck Cohort Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
1 year report 12/29/2018 11/23/2018 On Time
2 year report 12/29/2019 11/29/2019 On Time
3 year report 12/28/2020 11/04/2020 On Time
4 year report 09/20/2021 09/20/2021 On Time
5 year report 09/29/2022 09/14/2022 On Time
6 year report 09/29/2023 09/01/2023 On Time
7 year report 09/29/2024    
final report 09/29/2025    


Contact Us
Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

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