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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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Pipeline Flex Embolization w Shield Tech PAS


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General
Study Status Study Pending
Application Number P100018 S026/ PAS001
Date Current Protocol Accepted  
Study Name Pipeline Flex Embolization w Shield Tech PAS
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source Sponsor Registry
Comparison Group Objective Performance Criterion
Analysis Type Analytical
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description Prospective cohort. Will use sponsor’s “Product Surveillance Registry” platform.
Study Population Description Adult patients receiving Pipeline Flex Embolization Device with Shield Technology for treatment of intracranial aneurysm.
Sample Size 203
Data Collection Primary Endpoint: A patient will be considered a success if there is complete occlusion of the target aneurysm without significant parent artery stenosis (less than or equal to 50%), and the patient does not require retreatment of the target aneurysm.

Secondary Endpoints:

1. Incidence of complete aneurysm occlusion (defined as Raymond-Roy Class 1) without significant parent artery stenosis (less than or equal to 50%) or retreatment of the target aneurysm through 1- and 3-years post-procedure.

2. Incidence of device deployment success rate at the target site.

3. Incidence of target aneurysm recurrence and retreatment through 1- and 3- year post-procedure.

4. Incidence of major stroke in the territory supplied by the treated artery or neurological death through 3-years post-procedure.

5. Incidence of major stroke in the territory supplied by the treated artery or neurological death through 30 days post-procedure due to procedural complications.

6. Incidence of delayed intracerebral hemorrhage > 30 days through 1- and 3- years post-procedure.

7. Incidence of patients with disabling strokes that have a mRS decline to a score of 3 or more (mRS = 3) due to a stroke-related cause assessed at a minimum of 90

days post-stroke event at 1- and 3-years post-procedure.

8. Incidence of all strokes, both hemorrhagic and ischemic, through 1- and 3-years post-procedure.

Follow-up Visits and Length of Follow-up Patients will be followed for a minimum of 3 years.


Pipeline Flex Embolization w Shield Tech PAS Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 10/12/2021    
one year report 04/13/2022    
18 month report 10/12/2022    
two year report 04/13/2023    


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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