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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Cont f/u Dissection Study Subjects


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General
Study Status Ongoing
Application Number /
Requirement Number		 P200045 S002/ PAS001
Date Original Protocol Accepted 03/07/2023
Date Current Protocol Accepted  
Study Name Cont f/u Dissection 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 B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Objectives This study is a prospective, multicenter, non-blinded, non-randomized study designed to assess the RelayPro thoracic endografts in the treatment of acute, complicated type B aortic dissection that consists of continued follow-up of all available subjects from the IDE Pivotal Study.
Study Population Subjects with acute, complicated type B aortic dissections.
Sample Size A total of 56 subjects were enrolled in the IDE Pivotal Study.
Key Study Endpoints Clinical outcomes will include all-cause mortality, lesion-related mortality, major adverse events, false lumen perfusion, retrograde extension, fistula formation, stent graft kinking or twisting, patency, device misalignment, stent fracture, secondary interventions, conversion to open repair, occlusions, stenosis, all types of endoleaks, stent graft migration (>10 mm), aortic expansion (>5 mm), aortic rupture, loss of device integrity, and other device-related events
Follow-up Visits and Length of Follow-up 5 years


Cont f/u Dissection Study Subjects Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
interim report 09/28/2023 09/28/2023 On Time
1 year report 03/06/2024 03/04/2024 On Time
2 year report 03/06/2025    
3 year report 03/06/2026    
4 year report 03/06/2027    


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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