• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

  • Print
  • Share
  • E-mail
-

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.

Learn more...


             

New US Enrollment


Suggest Enhancement / Report Issue | export reports to excelExport to Excel
General
Study Status Progress Adequate
Application Number P100022 / PAS001
Date Current Protocol Accepted 02/15/2013
Study Name New US Enrollment
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Objective Performance Criterion
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description A prospective, single-arm, multicenter study of newly enrolled U.S. patients.
Study Population Description Patients with symptomatic vascular disease of the native above-the-knee femoro-popliteal arteries with a reference vessel diameter 4- 7 mm and total lesion lengths up to 140 mm per limb and 280 mm total.

The study has no control group. The comparator is performance goal of

83.1% at 1 year.

Sample Size 200 new patients enrolled from a minimum of 10 sites across the United

States.

Data Collection Primary Endpoint: Target lesion Revascularization (TLR) at 1 year. Secondary Endpoints: thrombosis, stent fracture other adverse events.
Follow-up Visits and Length of Follow-up 1 year

TLR assessment at 1 year.

Stent thrombosis and other adverse events assessments at pre-discharge and 1 year.

Interim or Final Data Summary
Actual Number of Patients Enrolled A total of two hundred (200) patients were enrolled for this PAS. This includes 149 patients treated with

stents less than or equal to 80 mm in length and 51 patients treated with stents greater than or equal to 100 mm in length.

Actual Number of Sites Enrolled Seventeen (17) investigational sites were enrolled across the United States for the post -approval study (US PAS).
Patient Follow-up Rate One hundred and ninety-four (194) of the 200 enrolled patents were eligible for 12 months visit and 175 patients completed the follow-up at 12 months for a rate 90.2% (175/194).
Final Safety Findings safety and effectiveness endpoints:

All patients

The 12-month freedom from target lesion revascularization (TLR) rate in patients treated with the Zilver PTX stent (91.8%, 95% confidence interval:87.2%, 94.8%) met the non- inferiority performance goal of 83.1% (z test statistics, p<0.001).



Study lesion thrombosis rate at 12 months was 2.5% (5/200). Stent fracture rate at 12 months was 0.4 (1/276).

The rate of amputation of study limb at 12 months was 2.5% (5/200).



The rate of worsened claudication/rest pain at 12 months was 13.5% (27/200).



Subgroups: Short stent group- patients treated with stents less than or equal to 80 m m in length vs. long stent group- patients treated with stents greater than or equal to 100 mm in length



The Kaplan-Meier estimates for freedom from TLR at 12 months for patients treated with stents less than or equal to 80 mm in length and those treated with stents greater than or equal to 100 mm in length were 91.9% and 92.2%, respectively (p=0.94, Log-Rank test), indicating no significant difference in the TLR rates between the subgroups.



The 12-month rate of study lesion thrombosis was 2.7% (4/149) for the short stent group and 2.0% (1/51) for the long stent group (p > 0.99).



Stent fracture rate at 12 months was 0.5% (1/214 stents) for the short stent group and 0% (0/62 stents) for the long stent group (P > 0.99).



The rate of amputation of study limb at 12 months was 3.4% (5/149) for the short stent group and 0% (0/51) for the long stent group.



The rate of worsened claudication/rest pain at 12 months was 14.8% (22/149) for the short stent group and 9.8% (5/51) for the long stent group.

Study Strengths & Weaknesses This was a single-arm, non-randomized multicenter study involving United States patients with follow- up up to 12 months (available patients will be followed through 5 years in the Zilver PTX Stent PAS or PAS2). The follow up rate at 12 months exceeded 80%. The study met the primary endpoint hypothesis with freedom from TLR rate greater than the 83.1% performance goal, therefore confirms the safety and effectiveness of the Zilver PTX stent in the post-approval setting.
Recommendations for Labeling Changes Labeling change is recommended to reflect the data from the post-approval study. The labeling change should include a new section in the label showing a summary of the post Approval study methods (including study objectives, design, population, number of enrolled sites/subjects, key endpoints, follow

–up visits etc.), results and study strengths and limitations.



New US Enrollment 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
two 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
Final Report 11/13/2017 11/14/2017 Overdue/Received


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

Related Links

-
-