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U.S. Department of Health and Human Services

Post-Approval Studies (PAS) Database

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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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Alto US and OUS Post-Approval Study


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General
Study Status Study Pending
Application Number P120006 S031/ PAS002
Date Current Protocol Accepted  
Study Name Alto US and OUS 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 Objective of this post-approval study is to collect safety, effectiveness, and neck dilatation data on Alto Abdominal Stent Graft System for the endovascular treatment of infrarenal abdominal aortic aneurysms and evaluate real-world outcomes in comparison to commercially available comparator devices.
Study Population Description The study population is patients with an infrarenal abdominal aortic aneurysm who met the anatomic criteria for implantation with the Alto device according to clinical guidelines and the treating physician’s judgement. Notably, treating physiscians will be making the determination regarding whether a subject should be enrolled and treated; they may request input from the Endologix Imaging Services.
Sample Size A minimum of 450 consented patients diagnosed with AAA who are considered candidates for endovascular repair and meet the study eligibility criteria. At least 300 will be allocated to the Alto cohort, and 150 to the comparator group.
Data Collection There are two primary endpoints: a clinical endpoint and a surrogate. The clinical endpoint is a composite of aneurysm-related complications (ARC), and consists of freedom from device-related interventions (for Type I & III endoleaks, stenosis/occlusion, migration, or other device-related cause), conversion to open surgery, Type I and III endoleaks, device migration (>10 mm), aneurysm sac enlargement (>5 mm), occlusion, aneurysm rupture, and aneurysm-related death. The surrogate is the hypothesized physiologic mechanism that leads to failure of several components within the clinical endpoint: proximal neck dilation over time. The surrogate allows for an early insight into eventual clinical sequelae.



All individual components of the primary endpoint will be evaluated as separate outcomes using the Kaplan-Meier approach. Results will be stratified by device cohort.

Follow-up Visits and Length of Follow-up Subjects will be followed for 5 years.


Alto US and OUS Post-Approval Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 09/11/2020 09/11/2020 On Time
one year report 03/13/2021 03/11/2021 On Time
quarterly report 05/28/2021 05/28/2021 On Time
18 month report 09/11/2021    
two year report 03/13/2022    
three year report 03/13/2023    
four year report 03/12/2024    
five year report 03/12/2025    


Contact Us

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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