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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 Follow-up IDE Study Subjects


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General
Study Status Study Pending
Application Number /
Requirement Number		 P210032 S015/ PAS001
Date Original Protocol Accepted 04/11/2025
Date Current Protocol Accepted  
Study Name Cont Follow-up IDE Study Subjects
Device Name GORE TAG Thoracic Branch Endoprosthesis (TBE Device)
Clinical Trial Number(s) NCT02777528  
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Study Population Adult: At least 22 yrs
Detailed Study Protocol Parameters
Study Objectives Assess the safety and effectiveness of the TAMBE Device in the treatment of thoracoabdominal aortic aneurysms (TAAA) and pararenal aortic aneurysms. This is continued follow up of the premarket cohort.
Study Population Patients with lesions of the aortic arch.
Sample Size 77
Key Study Endpoints Procedural Success (defined as Device Technical Success with the absence of serious adverse events at 30 days, including: death, disabling stroke, paraplegia, paraparesis, new onset renal failure requiring permanent dialysis, unanticipated reintervention related to the device or the procedure, new ischemia, distal device-related thromboembolic events requiring intervention, life threatening bleed, myocardial infarction, prolonged intubation, laryngeal or phrenic nerve injury, renal dysfunction or volume overload requiring ultrafiltration, severe heart failure or hypotension, aortic rupture, new dissection, or extension of a dissection (Dissection Cohort only)) and Treatment Success (defined as Device Technical Success, with absence of all of the following at all appropriate follow-up windows: lesion-related mortality, disabling stroke, paraplegia and paraparesis, protocol-defined reintervention, new ischemia, aortic rupture, loss of patency, fistula formation, loss of device integrity, device migration, new dissection, Type I/III endoleak, aortic enlargement, extension of dissection (Dissection Cohort only), false lumen perfusion through primary entry tear (Dissection Cohort only), and false lumen perfusion through an aortic arch branch vessel (Dissection Cohort only).
Follow-up Visits and Length of Follow-up 5 years


Cont Follow-up IDE Study Subjects Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
1 year report 04/11/2026   Overdue
2 year report 04/11/2027    
3 year report 04/10/2028    
4 year report 04/10/2029    


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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