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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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RelayPro Post-Approval Surveillance Study


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General
Study Status Progress Adequate
Application Number /
Requirement Number
P200045 / PAS002
Date Original Protocol Accepted 11/16/2021
Date Current Protocol Accepted  
Study Name RelayPro Post-Approval Surveillance Study
Device Name RelayPro Thoracic Stent-Graft System
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source Sponsor Registry
Comparison Group No Control
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 To collect real world, post-approval safety, performance, patient reported outcomes and health economic data on patients treated with Terumo Aortic endovascular stent-grafts in standard clinical practice.
This is a multi-center, open label, prospective observational registry enrolling new patients to obtain safety and performance data for the RelayPro Thoracic Stent-Graft System.
Study Population Patients requiring urgent or elective endovascular treatment of thoracic aortic aneurysm, pseudoaneurysm, dissection, penetrating aortic ulcer or intramural hematoma treated with the RelayPro Thoracic Stent-Graft System
There is no comparison group for the registry study
Sample Size A minimum of 177 aneurysm subjects treated with the RelayPro Thoracic Stent-Graft System will be enrolled. Of these a minimum of 88 patients will be enrolled in the U.S.
A sample size of 161 subjects provides 80% power (a =0.05) to distinguish any event that occurs at 1% or greater from 0. To allow for 10% attrition at 1 year, a minimum of 177 patients will be enrolled and analyzed.
Up to 80 global sites, including up to 40 US sites will be enrolled.
Key Study Endpoints Primary Outcome
The primary outcome is Aortic-related mortality, defined as any death due to aortic rupture, malperfusion or aortic dissection.
Secondary Outcomes
All-cause mortality
Technical Success
Clinical Success
Serious Adverse Events
Major Adverse Events
Patient Outcomes (Post-operative return to normal activities – employment, household activities, social life
and hobbies)
Procedure related health Economics (e.g., total procedure time, blood loss, volume of contrast used etc.)
Summary data to be posted on FDA website for interim and final reports include:
Aortic-related mortality
All-cause mortality
Aneurysm rupture
Aneurysm enlargement (>5mm)
Major Adverse Events
All types of endoleaks
Graft migration (>10mm)
Stent fracture and graft occlusion (including stenosis and kink)
Conversion to open surgery
Secondary interventions
Technical Success
Follow-up Visits and Length of Follow-up A minimum of 5 years


RelayPro Post-Approval Surveillance Study Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 02/03/2022 01/31/2022 On Time
1 year report 09/04/2022 09/02/2022 On Time
18 month report 02/03/2023    
2 year report 08/05/2023    
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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