f Post-Approval Studies (PAS) Database
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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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Continued f/u of the IDE Study Subjects


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General
Study Status Ongoing
Application Number /
Requirement Number		 P200045 / PAS001
Date Original Protocol Accepted 08/05/2021
Date Current Protocol Accepted  
Study Name Continued f/u of the IDE Study Subjects
Device Name RelayPro Thoracic Stent-Graft System
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Objective Performance Criterion
Analysis Type Descriptive
Study Population Transit. Adolescent A (distinctively) : 18-21 yrs, Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Objectives This is a prospective, single-arm, multicenter study that consists of continued follow-up of all available subjects from the IDE
Pivotal Study and the Continued Access Study
Study Population Subjects with TAAs and PAUs eligible for treatment with the RelayPro Thoracic Stent-Grafts
Sample Size A total of 110 subjects were enrolled in IDE Pivotal Study and 5 subjects were enrolled in the Continued Access Study
Key Study Endpoints Clinical outcomes will include all-cause mortality, lesion-related mortality, major adverse events, secondary interventions, conversion to open repair, occlusions, stenosis or kink, all types of endoleaks, stent graft migration (>10 mm), aneurysm expansion (>5 mm), aortic rupture, loss of device integrity, and other device-related events.
Follow-up Visits and Length of Follow-up 5 years


Continued f/u of the IDE Study Subjects Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
1 year report 09/04/2022 09/02/2022 On Time
2 year report 09/29/2023 09/28/2023 On Time
3 year report 08/04/2024    
4 year report 08/04/2025    


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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