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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) of 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 Cohort

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Study Status Completed
Application Number P110010 S001/ PAS002
Date Current Protocol Accepted 08/23/2012
Study Name OSB Lead-Continued F/U of Premarket Cohort
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source Sponsor Registry
Comparison Group No Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description Continued follow-up of premarket study, which is a concurrent, non-randomized, single-arm long lesion (LL) subtrial.
Study Population Description Patients who met the inclusion/exclusion criteria for the PLATINUM Long Lesion (LL) sub-study, evaluating the PROMUS Element¿ Everolimus-Eluting Platinum Chromium Coronary Stent System for the treatment of coronary artery disease.
Sample Size Cohort of 102 patients at 35 sites in the U.S., Europe, IC region and Japan.
Data Collection Target lesion revascularization (TLR) rate, target lesion failure (TLF) rate, target vessel revascularization (TVR) rate, target vessel failure (TVF) rate, myocardial infarction [ MI (Q-wave and non¿Q-wave)] rate, cardiac death rate, non-cardiac death rate, all death rate, cardiac death or MI rate, all death or MI rate, all death/MI/TVR rate, and stent thrombosis rate (definite or probable by ARC definitions)
Follow-up Visits and Length of Follow-up 5 years

18-Month, and 2, 3, 4, 5-Year Follow-Up

Interim or Final Data Summary
Actual Number of Patients Enrolled 102
Actual Number of Sites Enrolled 23
Patient Follow-up Rate 86.7% at 5years
Final Safety Findings 12 months

The 12 month primary effectiveness was met. For ITT patients, the 12 month TLF rate was 3.1% (3/96)

with upper 1-sided upper confidence bound 7.88% which is significantly less than the performance goal (PG) of 19.4% (p<0.001), and for per protocol patients the 12-month TLF rate was 3.2% (3/95) with 1- sided upper confidence bound of 7.96%, significantly less than the PG, 19.4% (P<0.001).

Final Effect Findings The main safety and effectiveness endpoint rates through 5 years in the Platinum LL sub-study are: Target lesion revascularization (TLR) 7.5%, target lesion failure (TLF) 13.6%, target vessel revascularization (TVR) 11.6%, target vessel failure (TVF) 17.7%, myocardial infarction (Q and non-Q wave) 1.3%, cardiac death 8.6%, Non cardiac death 2.2%, all death 10.6%, all death or MI 11.7%, All death, MI, TVR 20.7% and Academic Research Consortium (ARC)-defined Stent Thrombosis 1%.
Study Strengths & Weaknesses The Long lesion study met the primary endpoint and provided long term data. However the sample size was small and subgroup analyses were not conducted.
Recommendations for Labeling Changes Labeling change is recommended to reflect the long term data from the post-approval study. The labeling change should include a new section on 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.), final results and study strengths and limitations of the PAS.

OSB Lead-Continued F/U of Premarket Cohort Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
one year report 06/01/2013 05/23/2013 On Time
two year report 06/01/2014 05/29/2014 On Time
three year report (final report) 11/21/2015 02/23/2016 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

Phone: (301) 796-6134
Fax: (301) 847-8140

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