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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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Long Term Follow-up Study


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General
Study Status Progress Adequate
Application Number P150002 / PAS001
Study Name Long Term Follow-up 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 purpose of the post approval study is to evaluate the long-term safety and effectiveness of the INCCRAFT AAA Stent Graft System. It is a prospective, multi-center, single-arm clinical study. It involves the long-term follow-up of the premarket cohort.



Study Population Description The study population is patients with an infrarenal abdominal aortic aneurysm who met the study selection criteria.



Sample Size A total of 190 patients were enrolled.



Data Collection The primary endpoint is successful aneurysm treatment through 1 year post-procedure.



Additional endpoints will be collected and reported at each follow-up point through 5 years post procedure (through 10 years for patients with stent fracture(s) identified within the first 5 years), including Major Adverse Events (MAE), aneurysm enlargement (>5mm), aneurysm-related mortality, all types of endoleaks, aneurysm sac rupture, device integrity (e.g. stent strut fracture), device migration (>10 mm), graft occlusion, stenosis or kink, conversion to open surgery and secondary interventions.



Follow-up Visits and Length of Follow-up Patients will be followed for 5 years. Patients identified with stent fracture(s) within the first 5 years will be followed for an additional 5 years (total 10 years of follow-up).





Long Term Follow-up Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 08/27/2019 08/27/2019 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    


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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