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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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Registry Data Collection for Dissection


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General
Study Status Ongoing
Application Number /
Requirement Number
P200045 S002/ PAS003
Date Original Protocol Accepted 08/04/2023
Date Current Protocol Accepted  
Study Name Registry Data Collection for Dissection
Device Name RelayPro Thoracic Stent-Graft System
General Study Protocol Parameters
Study Design Active Surveillance
Data Source Sponsor Registry
Comparison Group No Control
Analysis Type Descriptive
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Objectives To collect real world, post-approval safety, performance, health economics and patient reported outcomes on patients treated with the RelayPro Thoracic Stent Graft System when used to repair Type B dissections in the descending thoracic aorta. This is a multi-center, prospective observational registry enrolling new patients
Study Population Patients requiring urgent or elective endovascular treatment of thoracic aortic acute and chronic dissections with the RelayPro Thoracic Stent-Graft System. There is no comparison group for the registry study.
Sample Size Number of subjects: A minimum of 60 patients with acute dissections and 60 patients with chronic dissections with a minimum of 50% of each indication from the US.
Assumptions for sample size estimation: A sample size of 120 provides 80% power (a =0.05) to distinguish an event that occurs with an incidence of 2% or greater from 0. That is, the 95% CI does not include 0.
Number of sites: 80
Sites location: US and OUS
Key Study Endpoints Technical success, defined as:
Successful delivery of the device through the vasculature (i.e. ability to deliver the implant to the intended location without the need for unanticipated corrective intervention related to delivery)
• Deployment of the endovascular stent-graft in the planned location with coverage of the target lesion (or entry tear in the case of dissection);
• Absence of unplanned coverage or aortic branch vessels;
• Patency of the endovascular stent-graft, absence of device deformations (e.g. kinks, stent eversion, maldeployment, misaligned deployment) requiring unplanned placement of an additional device within the endovascular stentgraft, and;
• Successful withdrawal (i.e. successful withdrawal of the delivery system, without the need for unanticipated corrective intervention related to withdrawal)
• Absence of Type Ia, Type Ib, Type IIIa and IIIb endoleak that extends beyond 30 days by confirmatory imaging (CTA, magnetic resonance angiography [MRA], or duplex ultrasound)
Clinical success, defined as the absence of:
• Target lesion related mortality
• Type Ia, Ib, IIIa and IIIb endoleak
• Graft infection
• Stent patency <50%
• Target lesion aortic rupture
• Conversion to open repair
• Arrest of the original pathological process (e.g., total aortic diameter expansion >5 mm in the aorta that has a study endograft, embolization from penetrating ulcer, extension of dissection, false lumen perfusion) or a new aortic pathology as a result of the intervention (e.g., pseudoaneurysm, dissection, intramural hematoma, unintentional adverse dissection septum rupture, stent-graft induced aortic wall injury, new aortobronchial/tracheal or aortoenteric fistula formation)
Additional endpoints:
• All-cause mortality
• Safety (MAEs, all related adverse events)
• Target lesion reintervention, all secondary interventions
• Device performance based on imaging assessments of all morphological variables (aortic remodeling, all endoleaks, any loss of patency, stent-graft migration, device integrity, etc.)
Patient outcome measures:
• Post-operative return to normal activities – employment, household activities, social life and hobbies (return to normal activities will be recorded at one year visit only)
Follow-up Visits and Length of Follow-up 30 days, 6 months, 1 year and annually thereafter through five years


Registry Data Collection for Dissection Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 09/29/2023 09/29/2023 On Time
1 year report 03/06/2024    


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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