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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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Post-Market Surveillance Study


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General
Study Status Study Pending
Application Number /
Requirement Number
P210032 / PAS002
Date Original Protocol Accepted 07/08/2022
Date Current Protocol Accepted  
Study Name Post-Market Surveillance Study
Device Name GORE TAG Thoracic Branch Endoprosthesis (TBE Device)
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source External 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 The GORE® TAG® Thoracic Branch Endoprosthesis Zone 2 Post-Market Surveillance is a single-arm, non-randomized, multicenter registry collecting data from consecutively treated Patients. The objective is
to ensure that the clinical outcomes during the commercial use of the GORE® TAG® Thoracic Branch Endoprosthesis are as anticipated.
Study Population Patients who undergo treatment with the GORE® TAG® Thoracic Branch Endoprosthesis at Sites participating in the SVS VQI.

Sample Size Max number of Patients: 350

Proximal Landing Zone: Zone 2 (per Study protocol)
Min number of Patients: 250
Min number of Patients enrolled by new Sites*: 60
Min number of Patients for specific pathologies:
• Acute Type B Dissection: 45
• Other Isolated Lesions (including PAU and IMH): 20
• Traumatic Transections: 25
A minimum of 100 evaluable Patients in Zone 2 will be available at 5-years. The minimum number of evaluable Patients at 5-years for specific pathologies will be:
• Acute Type B Dissection: 13
• Other Isolated Lesions (including PAU and IMH): 6
Traumatic Transections: 7

Key Study Endpoints Procedural Success: Device Technical Success and the absence of the following through the 1-Month follow-up window (181 days):
• Mortality (device- and disease or treatment-related)
• Stroke (mRS = 2) (through 30-days)
• Paraplegia / Paraparesis (through 30-days)
• Aortic rupture
• Type I/III endoleak
• Branch vessel occlusion requiring reintervention
• Additional surgical or interventional procedure related to the device or treatment (Reintervention)
Treatment Success: Device Technical Success and absence of the following through all follow-up windows (unless indicated)
• Mortality (device- and disease or treatment-related)
• Stroke (mRS = 2) (through 30-days only)
• Paraplegia / Paraparesis (through 30-days only)
• Aortic enlargement in the region encompassed by the initial lesion
• Aortic rupture
• Type I/III endoleak
• New dissections
• Loss of device integrity
• Device migration
• Loss of aortic/aortic branch patency
• Additional surgical or interventional procedure related to the device or procedure (Reintervention)
Additional endpoints of interest through all follow-up windows unless indicated:
• Access complications requiring additional intervention (procedural / periprocedural only)
• Stroke (mRS = 2)
• All-cause mortality
• New dissections requiring additional intervention / reintervention
• All endoleaks
• Branch vessel occlusion requiring reintervention
• False lumen status (dissection pathology only)
False lumen perfusion source (dissection pathology only)

Follow-up Visits and Length of Follow-up 120 months


Post-Market Surveillance Study Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 11/11/2022   Overdue
1 year report 05/13/2023    
18 month report 11/11/2023    
2 year report 05/12/2024    
3 year report 05/12/2025    
4 year report 05/12/2026    


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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