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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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Zilver PTX Stent PAS


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General
Study Status Progress Adequate
Application Number P100022 / PAS002
Date Current Protocol Accepted 01/13/2015
Study Name Zilver PTX Stent PAS
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
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 prospective, single-arm, multi-center study. Includes all subjects from the new US enrollment study, the Zilver PTX subjects from the premarket study, the Japanese post-approval study.
Study Population Description Comprises of PAS 1 subjects, the Zilver PTX subjects from the pivotal study, and earliest sequentially enrolled subjects in the Japan PAS that are consistent with the US PAS selection criteria with the exception that lesion length per limb may extend up to 200 mm.



Patients with symptomatic vascular disease of the native above-the-knee femoropopliteal arteries with a reference vessel diameter 4 to 7 mm and total lesion lengths up to 140 mm per limb and 280 mm total will be enrolled; for patients enrolled from the Japan PAS, lesion length per limb may extend up to 200 mm.

Sample Size The sample size will comprise of 200 patients from the new US Enrollment enrolled from minimum of 10 sites, 300 premarket RCT patients enrolled at

47 sites in the US, and approximately 400 patients from the Japan

postmarket study enrolled at 60-90 sites.

Data Collection Target lesion revascularization (TLR), patency by duplex ultrasonography, and stent thrombosis assessed annually through 5 years in 900 subjects.



Stent integrity assessed by x-ray imaging at 1, 3, and 5 years in 600 patients.

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

Annual follow-up through 5 years

Interim or Final Data Summary
Actual Number of Patients Enrolled Combined Cohort - 904

Pivotal – 305

Japanese Post-Approval Study – 399

US Post-Approval Study - 200
Actual Number of Sites Enrolled Combined Cohort – 158

Pivotal – 52

Japanese Post-Approval Study – 89

US Post-Approval Study - 17
Patient Follow-up Rate Combined Cohort

Baseline 100% (904/904);

1 Year 96.3% (810/841);

2 Years 93.0% (681/732);

3 Years 92.9% 588/633);

4 Years 94.0% (513/546)

5 Years 451 completed study



Pivotal

Baseline 100% (305/305);

1 Year 98.2% (277/282);

2 Years 93.1% (228/245);

3 Years 95.7% (198/207);

4 Years 91.3% (167/183)

5 Years 146 completed study



Japanese PAS

Baseline 100% (399/399);

1 Year
Final Safety Findings Safety endpoints assessed for the combined cohort included:

adverse events,

occurrence of TLR,

thrombosis, and

stent integrity through 5 years.

The primary safety hypothesis was freedom from TLR at 12-months against a performance goal of 83.1%.

12-month TLR rate of 91.8% met the non-inferiority performance goal of 83.1% (p < 0.0001).

5-year freedom from TLR rate - 80.8%.

Through 5 years, the freedom from thrombosis rate - 96.5%.

Stent integrity was assessed by X-ray at 1, 3, and 5 years.

5-year freedom from stent fracture rate of 98.5%

1 year – 3 fractures total

3 years – 12 fractures total

5 years – 14 fractures total

> 5 years – 16 fractures total
Final Effect Findings Effectiveness endpoint for the combined cohort was primary patency assessed by duplex ultrasound (PSVR < 2.0). Patency data were only available for the pivotal and US PAS studies; patency assessment was not required in the Japanese PAS.

5-year primary patency estimate - 59.3%.
Study Strengths & Weaknesses The follow-up compliance and study deviations were within reasonable expectations
Recommendations for Labeling Changes Additional information is available from these results that supplements information already contained in the publicly available SSED and labeling. Therefore, labeling changes are recommended


Zilver PTX Stent PAS Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 05/15/2013 05/14/2013 On Time
one year report 11/14/2013 11/14/2013 On Time
18 month report 05/15/2014 05/14/2014 On Time
2 year report 11/14/2014 11/13/2014 On Time
three year report 11/14/2015 11/13/2015 On Time
updated report 12/07/2015 12/07/2015 On Time
four year report 11/13/2016 11/14/2016 Overdue/Received
five year report 11/13/2017 11/14/2017 Overdue/Received
six year report 11/14/2018 11/14/2018 On Time
seven year report 11/14/2019 11/18/2019 Overdue/Received
eight year report 11/14/2020 11/13/2020 On Time
final report 05/31/2021 05/14/2021 On Time


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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