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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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Continued Follow-up of the IDE Study


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General
Study Status Study Pending
Application Number /
Requirement Number
P210032 / PAS001
Date Original Protocol Accepted 05/13/2022
Date Current Protocol Accepted  
Study Name Continued Follow-up of the IDE Study
Device Name GORE TAG Thoracic Branch Endoprosthesis (TBE Device)
General Study Protocol Parameters
Detailed Study Protocol Parameters
Study Objectives The primary objective of the study was to determine whether the GORE® TAG® Thoracic Branch Endoprosthesis (TBE device) is safe and effective in treating thoracic aortic pathologies while maintaining blood flow to the LSA. Specifically, the objective was to perform hypothesis-driven analysis of the device’s safety and effectiveness in the treatment of aortic aneurysms requiring proximal device placement in Zone 2 of the thoracic aorta.
Sample Size The IDE allowed for a minimum of 115 and up to a total of 315 Subjects
Key Study Endpoints Endpoints:
The Zone 2 study had a composite primary endpoint design, of eight overall components (one of the components ‘Device Technical Success’ has three further subcomponents). The composite can be considered a mixture of effectiveness and safety variables.

The Primary Endpoints for the Zone 2 Aneurysm hypothesis-driven study cohort are described below. A complete listing of these endpoint definitions and relevant assessment scales (Modified Rankin Scale (mRS), Spinal Cord Ischemia (SCI) scale and NIH Stroke Scake (NIHSS)).
The primary endpoint for the Zone 2 Aneurysm cohort was a composite of the following events through 12 months:
Device Technical Success
Successful access and delivery to the intended implantation site, and retrieval of the device delivery system, and;
Patency of the graft, and;
The absence of unanticipated additional procedure related to the device, procedure, or withdrawal of the delivery system

Absence of the following:
Aortic rupture
Lesion-related mortality
Disabling stroke
Permanent paraplegia
Permanent paraparesis
New onset renal failure requiring permanent dialysis
Additional unanticipated post-procedural surgical or interventional procedure related to the device, procedure, or withdrawal of the delivery system

In addition to the Primary Endpoints noted above, Procedural and Treatment Success data (aggregate and components) were collected and analyzed for all Zone 2 cohorts.

Procedural Success was defined as Device Technical Success (defined in Section 7.4.1), with absence of the following events occurring from the initiation of the index endovascular procedure through 1 month:
Death (Through 30 days only)
Aortic rupture (Through 30 days only)
Disabling stroke
Paraplegia (Through 30 days only)
Paraparesis (Through 30 days only)
New onset renal failure requiring permanent dialysis
Additional unanticipated post-procedural surgical (including conversion to open surgery) or interventional (placement of additional unanticipated endovascular devices) procedure related to the device, procedure, or withdrawal of the delivery system
New ischemia
Distal device-related thromboembolic adverse event requiring intervention or surgery
Extension of a dissection (proximally or distally) (Dissection cohort only)
New dissection
Life-threatening bleed
Myocardial infarction
Prolonged intubation
Laryngeal or Phrenic Nerve injury
Renal dysfunction or volume overload requiring ultrafiltration
Severe Heart Failure/Hypotension

Treatment Success was defined as Device Technical Success, with absence of the following events occurring from the initiation of the index endovascular procedure and at all appropriate follow-up windows:
Aortic enlargement in the region encompassed by the initial lesion
Aortic rupture
Extension of a dissection (proximally or distally) (Dissection cohort only)
New dissection
False lumen perfusion through the primary entry tear (Dissection cohort only)
False lumen perfusion through an aortic arch branch vessel (Dissection cohort only)
Type I or III endoleak
Fistula formation
Lesion-related mortality
Loss of device integrity
Loss of aortic or aortic branch patency
Migration
Disabling stroke within 30 days of the index endovascular procedure only
Paraplegia within 30 days of the index endovascular procedure only
Paraparesis within 30 days of the index endovascular procedure only
New ischemia
Additional unanticipated post-procedural surgical (including conversion to open surgery) or interventional (placement of additional unanticipated endovascular devices) procedure related to the device, procedure, or withdrawal of the delivery system

Follow-up Visits and Length of Follow-up 5-years, 60 months follow-up


Continued Follow-up of the IDE Study Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
1 year report 05/13/2023    
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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