• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

  • Print
  • Share
  • E-mail
-

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.

Learn more...


             

OSB Lead-Comprehensive/Linked-Registry Based Surv


Suggest Enhancement / Report Issue | export reports to excelExport to Excel
General
Study Status Progress Adequate
Application Number P040043 S051/ PAS002
Date Current Protocol Accepted  
Study Name OSB Lead-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 Design Description Objectives: to support and actively participate as a stakeholder in the Society for Vascular Surgery Patient Safety Organization-governed Vascular Quality Initiative (VQI) and undertake such activities to ensure that surveillance occurs for the TAG device when used to repair Type B dissections in the descending thoracic aorta.

Study Population Description Two surveillance arms:

a. Five (5)-year: Data will be captured on a minimum of 200 chronic and 200 acute patients with device technical success, and treated at centers agreeing to participate in the surveillance through the VQI registry. This includes patients treated on or after September 10, 2013 (date of first device approval).



b. One (1)-year: Standard VQI data will be captured on all-comers to the VQI registry. This includes patient treated after the 5Tthoracic endovascular aortic repair5T (TEVAR) forms are released and will end after 200 patients have been surveilled.

Sample Size Two surveillance arms:

a. Five (5)-year: 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 patients has been reached for one arm (acute or chronic) 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.



b. One (1)-year: All-comers until 200 patients have been surveilled to the VQI registry.

Data Collection 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

5year arm: Freedom from dissection related mortality at 5 years

1year 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:

paraplegia*+

paraparesis*+

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.



OSB Lead-Comprehensive/Linked-Registry Based Surv Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
FDA 6 month report 03/11/2015 03/16/2015 On Time
FDA 1 year report 09/10/2015 09/10/2015 On Time
FDA 18 month report 03/11/2016 03/07/2016 On Time
FDA 2 year report 09/10/2016 09/12/2016 Overdue/Received
FDA 3 year report 09/09/2017 09/22/2017 Overdue/Received
FDA 4 year report 09/09/2018    
FDA 5 year report 09/09/2019    
FDA 6 year report 09/09/2020    


Contact Us

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD
20993-0002

Phone: (301) 796-6134
Fax: (301) 847-8140
julie.unger@fda.hhs.gov

Related Links

-
-