Post-Approval Studies (PAS) Database

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

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
Clinical Trial Number(s)	NCT01534819
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	08/21/2024	On Time
final report	09/29/2025

Contact Us

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

Additional Resources

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• Guidance Document: "Procedures for Handling Post-Approval Studies Imposed by PMA Order"
• PAS Program Background