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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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Comprehensive/Linked-Registry Based Surv.

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Study Status Progress Adequate
Application Number /
Requirement Number
P100040 S012/ PAS002
Date Original Protocol Accepted 06/23/2014
Date Current Protocol Accepted  
Study Name Comprehensive/Linked-Registry Based Surv.
General Study Protocol Parameters
Study Design Comprehensive/Linked/RegistryBased Surveillance
Data Source External Registry
Comparison Group No Control
Analysis Type Descriptive
Detailed Study Protocol Parameters
Study Objectives The purpose of this surveillance project, using the Society for Vascular Surgery Vascular Quality Initiative (SVS VQI) registry, will be to obtain data that can be used to refine the selection of and treatment strategy for patients with Type B aortic dissections managed through endovascular graft repair. Data will also be evaluated to identify any signals of device-specific safety or effectiveness issues. This project will be used to establish performance goals for future studies.
Specifically, the project will evaluate the short- and long-term clinical performance of endovascular grafts for the treatment of Type B thoracic aortic dissection, following premarket approval.
This is a cohort study of patients entered into the VQI registry, treated for Type B thoracic aortic dissection. The project will be comprised of (1) a cohort of patients followed through five years post-implant procedure (this will include a sub-cohort of the 1-year cohort); and (2) a cohort of all-comers followed through one year post-implant procedure.
Study Population Inclusion criteria:
Patients whose index procedure is on or after September 10, 2013 (date of first device approval) for treatment with an endovascular stent-graft used to repair Type B dissections in the descending thoracic aorta may be included in the 1-year or 5-year cohort.

Patients diagnosed with classic “double-barrel” Type B thoracic aortic dissection in the descending thoracic aorta and an identifiable intimal flap, with visible contrast enhancement in the false lumen that are treated with endovascular grafts at centers participating in the VQI registry.

For the 5-year cohort, subjects will be considered enrolled in the study after arterial cut- down and introduction of the endovascular graft. Data will be collected for unsuccessfully implanted patients through their in-hospital stay.

Exclusion criteria:
Medial disruption with formation of intramural hematoma/hemorrhage.

Plaque rupture leading to aortic ulceration, penetrating aortic atherosclerotic ulcer with surrounding hematoma, usually subadventitial.

Iatrogenic and traumatic dissection.
Sample Size Two surveillance arms:
Five (5)-year cohort: Data will be captured on a minimum of 194 chronic and 200 acute patients with Device Technical Success, and treated at centers agreeing to participate in the Surveillance Project through the VQI registry. At least 60 patients treated with the final device design of a participating manufacturer will be enrolled in each surveillance arm (i.e., acute and chronic). If the total sample size of 200 or 194 patients has been reached for one arm (acute or chronic, respectively) of the 5-year surveillance arm, but an individual device has not met the 60 patients minimum required for that arm, enrollment will only continue for that specific device.
One (1)-year: All-comers until 200 patients have been surveilled into the VQI registry during the specified enrollment period.

Key Study Endpoints The sponsor will report any significant observations from the surveillance described below of the use of the TAG device to repair Type B dissections in the descending thoracic aorta. Specifically, this surveillance should monitor:
Primary Safety (All devices combined)
5-year arm:
Freedom from dissection-related mortality at 5 years
1-year arm:
Freedom from dissection-related mortality through 1 year

Primary Effectiveness
5-year arm:
Device technical success at the time of the procedure (successful delivery, successful and accurate deployment, and successful withdrawal of the delivery system)
Device procedural success at 30 days (device technical success with absence of the following at 30 days: major adverse events [MAE] subset, primary intimal tear false lumen perfusion [PIT FLP], retrograde extension of the dissection, and unintentional dissection septum rupture).
1-year arm:
Device technical success at the time of the procedure (successful
delivery, successful and accurate deployment, and successful withdrawal of the delivery system)

Secondary endpoints
5-year arm:
Elements of device technical and procedural success
Additional endovascular and surgical dissection-related interventions pre-procedure, index-procedure, and post-index procedure (within 30 days, 1 year, yearly)

The following endpoints at 30 days, 1 year and yearly assessments:
Dissection treatment success and its individual elements:
Aortic enlargement in the region encompassed by the initial dissection (1 year and yearly only)
Aortic rupture
Dissection-related mortality
Extension of the dissection (proximally or distally) with or without complications
False lumen perfusion (FLP)
primary intimal tear Proximal aorta
Distal aorta
Proximal branch
Distal branch
Fistula formation (e.g., aorto-esophageal, aorto-tracheal)
MAEs subset
Unintentional dissection septum rupture
Conservative estimate of dissection-related mortality
All-cause mortality
False lumen patency
Endovascular device penetration of the aortic wall
Loss of device integrity

1-year arm:
Elements of device technical success
The following endpoints at procedure and 1 year assessments:
FLP (all elements)
Aortic enlargement in the region encompassed by the initial dissection (1 year only)
Aortic rupture
Dissection-related mortality
Conservative estimate of dissection-related mortality
All-cause mortality
MAEs subset
Additional endovascular and surgical dissection-related interventions

Major adverse events are pre-specified as:
disabling stroke*
non-preexisting and sustained contrast-induced renal failure requiring dialysis not due to malperfusion of the kidneys present at presentation*
new ischemia (i.e., not evident at the time of the index procedure) due to branch vessel compromise (malperfusion of organ, upper limb, or lower limb)†
*Subset of MAEs for device procedural success
†Subset of MAEs for dissection treatment success and 1-year arm

Follow-up Visits and Length of Follow-up 5-year cohort: 30 days, 1 year, and annually through 5 years following the index procedure.
1-year cohort: 30 days and 1 year following the index procedure.

Comprehensive/Linked-Registry Based Surv. Reporting Schedule

Reporting Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
FDA 6 month report 07/23/2014 07/21/2014 On Time
FDA one year report 01/22/2015 01/14/2015 On Time
FDA 18 month report 07/23/2015 07/17/2015 On Time
FDA 2 year report 01/22/2016 01/13/2016 On Time
FDA 3 year report 01/21/2017 01/18/2017 On Time
FDA 4 year report 01/21/2018 01/18/2018 On Time
FDA 5 year report 01/21/2019 01/16/2019 On Time
FDA 6 year report 01/21/2020 12/20/2019 On Time
FDA 7 year report 01/21/2021 01/13/2021 On Time
FDA 8 year report 01/21/2022 01/10/2022 On Time
FDA final report 06/28/2023 06/27/2023 On Time

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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