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U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

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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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OSB Lead-Popliteal Indication PAS Surv Project


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General
Study Status Progress Adequate
Application Number P070014 S037/ PAS001
Date Current Protocol Accepted  
Study Name OSB Lead-Popliteal Indication PAS Surv Project
General Study Protocol Parameters
Study Design Comprehensive/Linked/RegistryBased Surveillance
Data Source External Registry
Comparison Group No Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description To conduct long term post-market surveillance of the safety

(including stent fractures assessed at revision) and effectiveness of the Bard LifeStent Vascular Stent Systems for the treatment of symptomatic de novo or restenotic lesions in the popliteal artery



A prospective surveillance project using the Vascular Quality

Initiative (VQI) Peripheral Vascular Intervention (PVI) registry to evaluate consecutive patients treated for symptomatic de novo or restenotic lesions of the popliteal artery with the LifeStent. The surveillance project involves new enrollment.



Patient information will be collected according to standard of care practice through 24 months post index procedure

Study Population Description All eligible patients with symptomatic de novo or restenotic lesions in the popliteal artery (P2/P3) that receive treatment with the Bard life Stent.
Sample Size A minimum of 74 patients will be treated with the LifeStent in P2/P3 lesions.
Data Collection Primary Post Approval Surveillance Project Endpoints

Safety:

Freedom from Major Adverse Events (MAE) defined as device and/or procedure-related death or target limb(s) major amputation through 12-months post- index procedure.

Effectiveness:

Freedom from Target Lesion Revascularization (TLR) and/or Target Vessel Revascularization (TVR) at 12- months post-index procedure.



Secondary Post Approval Surveillance Project Endpoints:

Acute Lesion Success defined as attainment of < 30% residual stenosis of the target lesion after the index procedure using any percutaneous method and/or non-investigational registry device (i.e., post- dilatation).

Acute Procedure Success defined as lesion success and no peri-procedural complications prior to hospital discharge, and the following secondary endpoints assessed at 12 and 24 months post index procedure:



Primary Patency assessed with Doppler ultrasound (DUS)

Primary Assisted Patency assessed with DUS

Secondary Patency assessed with DUS

Sustained Clinical Success

Sustained Hemodynamic Success



Stent fracture rate will be assessed by Core Lab inter- pretation of images obtained during target lesion revascularization classified as Types I to IV.

Follow-up Visits and Length of Follow-up 2 years


OSB Lead-Popliteal Indication PAS Surv Project Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 11/29/2016 12/01/2016 Overdue/Received
one year report 05/31/2017 06/01/2017 Overdue/Received
18 month report 11/29/2017    
two year report 05/31/2018    
three year report 05/31/2019    
Final Report 03/31/2020    


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

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