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| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P070014 S037/ PAS001 |
| Date Original Protocol Accepted |
08/31/2016
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| Date Current Protocol Accepted |
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| Study Name |
Popliteal Indication PAS Surv Project
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| Device Name |
BARD LIFESTENT VASCULAR STENT SYSTEM
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| General Study Protocol Parameters |
| Study Design |
Comprehensive/Linked/RegistryBased Surveillance
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| Data Source |
External Registry
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| Comparison Group |
No Control
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| Analysis Type |
Descriptive
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| Study Population |
Adult: >21
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| Detailed Study Protocol Parameters |
| Study Objectives |
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
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| Study Population |
All eligible patients with symptomatic de novo or restenotic lesions in the popliteal artery (P2/P3) that receive treatment with the Bard life Stent.
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| Sample Size |
A minimum of 74 patients will be treated with the LifeStent in P2/P3 lesions.
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| Key Study Endpoints |
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.
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| Follow-up Visits and Length of Follow-up |
2 years
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| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
Seventy-four (74) subjects were enrolled, and 76 legs were treated in the 74 subjects.
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| Actual Number of Sites Enrolled |
Twenty-nine (29) sites were enrolled. Nineteen (19) sites enrolled at least one subject.
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| Patient Follow-up Rate |
87.8% (65/74) and 79.0% (49/62) at 1 year and 2 years, respectively
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| Final Safety Findings |
Primary Safety Endpoint
Freedom from device and/or procedure-related death and freedom from target major limb amputation at 1 year by Kaplan Meier estimate was 98.6% and 90.9%, respectively.
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| Final Effect Findings |
Primary Effectiveness
Freedom from target vessel revascularization (TVR) and target lesion revascularization (TLR) at 1 year by Kaplan Meier estimate was 84.9% and 86.3%, respectively.
Secondary Endpoints
Acute lesion success rate was 98.7% (75/76) at pre-discharge
Acute procedure success rate was 81.6% (62/76) at pre- discharge.
Limb ischemia assessed by change in Rutherford class decreased in 86.5% (45/52) and 86.8% (33/38) of evaluable subjects at 12months and 24 months, respectively.
Ankle brachial index increased in 77.3% (17/22) and 86.7% (13/15) of evaluable subjects at 12 months and 24 months. Stent fracture rate at 12 months was 11% (1/9).
Primary patency rate at 12 and 24 months by Kaplan Meier estimate was 80.5% and 68.1%, respectively.
Primary assisted patency rate at 12 and 24 months by Kaplan Meier estimate was 80.5% and 68.1%, respectively.
Secondary patency rate at 12 and 24 months by Kaplan Meier estimate was 89.4% and 78.9% respectively.
Sustained clinical success at 12 and 24 months by Kaplan Meier estimate was 98.5% and 95.9% respectively.
Sustained Hemodynamic success at 12 and 24 months by Kaplan Meier estimate was 100% and 81.2%, respectively.
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| Study Strengths & Weaknesses |
This is an observational surveillance project involving use of real- world evidence. Therefore, patients were treated according to standard of care practice. The sample size estimation was not hypothesis- driven and the study endpoint results were not evaluated with formal hypothesis testing.
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| Recommendations for Labeling Changes |
Labeling change is recommended to reflect the long-term results of the post approval study. The labeling change should include a new section in the label showing a summary of the surveillance objective, design, patient population, data source, sample size including number of sites, endpoints, length of follow-up and frequency of follow-up, final results (final endpoint results, follow-up rate etc.), strengths and limitations of the surveillance project.
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