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U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

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

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OSB Lead-Continued F/u of Premarket and OUS Cohort


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General
Application Number P110013 S005/ PAS002
Current Plan Approved 02/22/2013
Study Name OSB Lead-Continued F/u of Premarket and OUS Cohort
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source Sponsor Registry
Comparison Group No Control
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description The 38 mm Length Group is designed as a prospective analysis of the pooled data from patients treated with a 38 mm stent from two multi-center, non-randomized studies, RESOLUTE US (R-US) and RESOLUTE Asia (R-Asia).
Study Population Description Subjects enrolled in the Global Resolute Clinical Program
Sample Size 223 subjects (Consists of patients from 38 mm sub studies of R-US (N=114) and R-Asia (N=109))
Data Collection Primary Endpoints

Stent Thrombosis rates from 12-24, 24-36, 36-48 and 48-60 months

Cardiac Death/TV MI annual rates up to 5 years post procedure.
Follow-up Visits and Length of Follow-up Patient Contact (assessed by telephone, email and/or office visit):

Annually 2, 3 years (R-Asia)*

Annually 2, 3, 4, 5 years (R-US)

Note: R-Asia patients were consented for 5 years. At 3 years if the event rates are demonstrated to plateau or decrease as compared to the rates in the prior years the Steering Committee and Sponsor may consider stopping further follow-ups.


OSB Lead-Continued F/u of Premarket and OUS Cohort Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
one year report 02/22/2014 03/31/2014 On Time
two year report 03/31/2015 03/30/2015 On Time
three year report 03/31/2016 02/29/2016 On Time
four year report 03/31/2017    


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

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