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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Aorfix Post Approval Study

General
Study Status	Terminated
Application Number / Requirement Number	P110032 / PAS001
Date Original Protocol Accepted	11/01/2013
Date Current Protocol Accepted	11/01/2013
Study Name	Aorfix Post Approval Study
Device Name	AORFIX FLEXIBLE STENT GRAFT SYSTEM
Clinical Trial Number(s)	NCT00522535
General Study Protocol Parameters
Study Design	Prospective Cohort Study
Data Source	External Registry
Comparison Group	Historical Control
Analysis Type	Analytical
Study Population	Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Objectives	The study is a prospective observational study with a historical control, including both prospective follow-up of newly enrolled subjects, plus continued follow-up of the premarket cohort.
Study Population	The study will include 234 prospectively enrolled subjects treated in accordance with the IFU for the device plus all 221 Aorfix¿ subjects enrolled into Lombard Medical¿s IDE study.
Sample Size	455 subjects, including 234 newly enrolled subjects plus 221 from the premarket cohort. A minimum of 20 sites
Key Study Endpoints	 Aneurysm-related mortality at 5 years (primary endpoint)  Major adverse events at 30 days, and annually through 5 years  Type I and III endoleaks  Device migration  Fracture in fixation zone  Conversion to open surgery  Change in aneurysm size  Aneurysm rupture
Follow-up Visits and Length of Follow-up	5 years 30 day post-implant, one year, and annually thereafter

Aorfix Post Approval Study Reporting Schedule

Reporting Schedule	Report Date Due	FDA Receipt Date	Applicant's Reporting Status
six month report	08/15/2013	11/27/2013	Overdue/Received
one year report	02/14/2014	03/14/2014	Overdue/Received

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