• 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) approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

Learn more...


             

OSB Lead-Zilver PTX Stent PAS


Suggest Enhancement / Report Issue | export reports to excelExport to Excel
General
Application Number P100022 / PAS002
Current Plan Approved 01/13/2015
Study Name OSB Lead-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



OSB Lead-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    
five year report 11/13/2017    


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

-
-