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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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INCRAFT US Post-Approval Study


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General
Study Status Study Pending
Application Number P150002 / PAS002
Date Current Protocol Accepted  
Study Name INCRAFT US Post-Approval Study
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 Design Description 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 Description All-comers population



Sample Size A minimum of 250 patients will be enrolled.



Data Collection 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 Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 05/28/2019   On Time
one year report 11/27/2019    
18 month report 05/27/2020    
two year report 11/26/2020    
three year report 11/26/2021    
four year report 11/26/2022    


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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