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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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PAS-Post-Market Surveillance Study/LongTerm Safety


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General
Study Status Study Pending
Application Number P170013 / PAS001
Date Current Protocol Accepted  
Study Name PAS-Post-Market Surveillance Study/LongTerm Safety
General Study Protocol Parameters
Study Design Prospective & Retrospective Study
Data Source Sponsor Registry
Comparison Group No Control
Analysis Type Descriptive
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description A multi-center, real-world evidence (RWE), single arm, retrospective and prospective study



Study Population Description The study population conforms to currently approved Indications for Use: Subjects with wide-necked (neck greater than or equal to 4 mm or dome to neck ratio < 2) intracranial, saccular aneurysms arising from a parent vessel with a diameter greater than or equal to 2.0 mm and less than or equal to 4.5 mm who underwent treatment with LVIS device since approval in the local geography of researched sizes.



Sample Size All patients treated under HDE and IDE pivotal study with the researched LVIS devices sizes.



Data Collection Clinical Outcomes:

1. Complete or stable Raymond-Roy II intracranial aneurysm occlusion

2. Intracranial hemorrhage including SAH and IPH

3. All ischemic and hemorrhagic strokes

4. Neurological deaths

5. Transient Ischemic Attacks (TIAs)

6. Parent artery patency

7. In-stent stenosis

8. Target aneurysm retreatment

9. Cerebral vasospasm



Follow-up Visits and Length of Follow-up up to 5 years


PAS-Post-Market Surveillance Study/LongTerm Safety Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 11/28/2018 11/29/2018 Overdue/Received
one year report 05/30/2019 05/29/2019 On Time
18 month report 11/28/2019 11/27/2019 On Time
two year report 06/30/2020 05/22/2020 On Time
three year report 05/29/2021   Overdue


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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