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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INCRAFT US Post-Approval Study

General
Study Status	Study Pending
Application Number / Requirement Number	P150002 / PAS002
Date Original Protocol Accepted	03/26/2019
Date Current Protocol Accepted
Study Name	INCRAFT US Post-Approval Study
Device Name	INCRAFT(R) AAA STENT GRAFT SYSTEM
Clinical Trial Number(s)	NCT01664078
General Study Protocol Parameters
Study Design	Prospective Cohort Study
Data Source	New Data Collection
Comparison Group	No Control
Analysis Type	Descriptive
Study Population	Adult: >21
Detailed Study Protocol Parameters
Study Objectives	The INCRAFT U.S. Post Approval Study is a multi-center, open label, single arm, prospective post approval study. The objective of the study is to collect real-world safety and effectiveness outcomes of the INCRAFT® AAA Stent Graft System in an all-comers population eligible for the endovascular treatment of abdominal aortic aneurysms in routine clinical practice.
Study Population	All-comers population
Sample Size	A minimum of 250 patients will be enrolled.
Key Study Endpoints	The primary endpoint is successful aneurysm treatment through 2 years post-procedure. Technical success at the conclusion of the index procedure, defined as: Successful delivery, (i.e. ability to deliver the implant to the intended location without the need for unanticipated corrective intervention related to delivery); Successful and accurate deployment, defined as: deployment of the endovascular stent graft in the planned location; ¿ patency of the endovascular stent graft, absence of device deformations, (e.g. kinks, stent eversion, mal-deployment, misaligned deployment) requiring unplanned placement of an additional device within the endovascular stent graft, and; Successful withdrawal (i.e. successful withdrawal of the delivery system, without the need for unanticipated corrective intervention related to withdrawal) ¿ Absence of post-operative aneurysm enlargement (growth > 5 mm) or stent graft migration (> 10 mm) compared to the one-month size measurement; ¿ Absence of aneurysm rupture, endoleak Type I / III, or graft occlusion (including unilateral or bilateral limb occlusion); ¿ Absence of post-operative conversion to open surgery ¿ Absence of secondary intervention to address migration, patency-related events, Type I/III endoleaks, or fracture.
Follow-up Visits and Length of Follow-up	All patients will receive 2 years of follow-up. Patients identified with fracture(s) within the first 2 years will be followed annually for an additional 3 years for a total of 5 years of follow-up.

INCRAFT US Post-Approval Study Reporting Schedule

Reporting Schedule	Report Date Due	FDA Receipt Date	Applicant's Reporting Status
six month report	05/28/2019	05/24/2019	On Time
one year report	11/27/2019	11/21/2019	On Time
18 month report	05/27/2020	05/26/2020	On Time
two year report	11/26/2020	11/23/2020	On Time
3 year report	11/26/2021	11/23/2021	On Time
4 year report	11/26/2022	11/07/2022	On Time
5 year report	11/26/2023	11/22/2023	On Time
6 year report	11/26/2024

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