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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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Popliteal Indication PAS Surv Project

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Study Status Progress Adequate
Application Number P070014 S037/ PAS001
Date Current Protocol Accepted  
Study Name 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
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.
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
Interim or Final Data Summary
Interim Safety Information Primary Safety
Freedom from device and/or procedure related death rate at 30 days and 1 year was 100% at each timepoint. Freedom from target limb(s) major amputation was 100% at 30 days and 70.5% at 1 year.
Primary Effectiveness
Freedom from target vessel revascularization (TVR) was 100% at 30 days and 87.6% at 1 year post index procedure. Freedom from target lesion revascularization (TLR) was 100% at 30 days and 94.4% at 1 year post index procedure.
Secondary Endpoints
Acute Lesion Success rate was 98.1% (51/52).
Acute Procedure Success rate was 78.8% (41/52).
Primary patency rate at 12 months by Kaplan Meier (KM) estimate was 100%
Primary assisted patency rate at 12 months by KM estimate was 86.6%.
Secondary patency rate at 12 months by KM estimate was 86.6%.
Sustained clinical success at 12 months by KM estimate was 100%.
Sustained Hemodynamic Success at 12 months by KM estimate was 88.2%
Limb ischemia assessed via change in Rutherford Class decrease in 80% (8/10) of subjects at 12 months.

Strengths and Weaknesses
A registry-based prospective surveillance study involving several clinical sites. Study enrollment has improved within this reporting period. Data on 12-month outcomes is limited as only 13 subjects have completed follow-up at the time as database closure for this report April 4, 2019.
Actual Number of Patients Enrolled Fifty-one (51) subjects have been enrolled, and a total of fifty-two (52) limbs were treated.
Actual Number of Sites Enrolled Thirty-five (35) sites have been approved to participate in the registry study and twenty-eight (28) sites have been contracted and trained to enroll subjects.
Patient Follow-up Rate Follow up rate at 12 months was 76.5% (13/17).

Popliteal Indication PAS Surv Project Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
6 month report 11/29/2016 12/01/2016 Overdue/Received
1 year report 05/31/2017 06/01/2017 Overdue/Received
18 month report 11/29/2017 12/01/2017 Overdue/Received
2 year report 05/31/2018 05/31/2018 On Time
3 year report 05/31/2019 06/03/2019 Overdue/Received
4 year report 05/31/2020 06/01/2020 Overdue/Received
5 year report 06/01/2021 06/01/2021 On Time
final report 05/31/2022 06/02/2022 Overdue/Received

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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