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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-PROMUS Element Plus US PAS


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General
Application Number P110010 / PAS001
Current Plan Approved 05/10/2012
Study Name OSB Lead-PROMUS Element Plus US PAS
General Study Protocol Parameters
Study Design Other Study Design
Data Source Sponsor Registry
Comparison Group Historical Control
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description Prospective, open-label, multi-center registry study
Study Population Description PLATINUM-like patients
Sample Size Approximately 2,689 patients will be enrolled consecutively from up to 65 sites in order to attain 906 PLATINUM-like patients (33.7% of the enrolled patients). Each site may enroll up to a maximum of 200 patients.



A minimum of 200 subjects will be treated with the stent lengths 32/38 mm (diameters 2.5-4.00 mm) and 288 PLATINUM-like medically treated diabetic subjects.



Approximately 1,706 and 345 PLATINUM-like subjects are required to provide 80% power to test the hypotheses for the primary and medically treated diabetic subset endpoints, respectively. A minimum of 1,660 PLATINUM-like patients at 5-years will be required to provide 90% power to test the secondary endpoint for the annual increase in the ST rates starting at 12 months.

Data Collection Primary Endpoint

The primary endpoint is the cardiac death or myocardial infarction (CD/MI) rate through 12 months post stent implantation expressed as the proportion of PLATINUM-like patients who experience CD/MI within 365 days among all PLATINUM-like patients who either experience

12-month CD/MI or survive free of CD/MI for at least 335 days.



Secondary Endpoints

Stent thrombosis (ST) rate, using ARC definition (definite/probable) in the following populations: overall patient population, the PLATINUM-like patient population (from this post-approval study) and the non-PLATINUM-like patient population (from this post-approval study).

Rate of longitudinal stent deformation. Angiograms from reported cases of longitudinal stent deformation will be sent to the angiographic core lab for review.

Overall and PROMUS Element Plus-related major adverse cardiac event (MACE) rates (cardiac death, MI, target vessel revascularization-TVR).

Overall and PROMUS Element Plus-related cardiac death or MI rates.

Overall and PROMUS Element Plus-related target vessel failure (TVF) rates.

Overall and PROMUS Element Plus-related TVR rates.

Overall and PROMUS Element Plus-related cardiac death rates.

Overall and PROMUS Element Plus-related MI rates.

All death rates

Non-cardiac death rates

All death or MI rates



The secondary endpoints will be assessed for all patients at less than or equal to 24 hours, 30 days, 180 days, and annually through 5 years post-index stent implantation.



Endpoint for PLATINUM-like Medically Treated Diabetic Subset

The pre-specified endpoint for the PLATINUM-like medically treated diabetic subset is the TVF rate for PLATINUM-like medically treated diabetics through 12-month follow- up expressed as the proportion of PLATINUM-like medically treated diabetic patients who experience TVF within 365 days among all PLATINUM-like medically treated diabetic patients who either experience 12-month TVF or survive free of TVF for at least 335 days.



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





OSB Lead-PROMUS Element Plus US PAS Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
three month report 02/22/2012 02/22/2012 On Time
six month report 05/22/2012 05/22/2012 On Time
9 month report 08/21/2012 08/22/2012 Overdue/Received
one year report 11/21/2012 11/16/2012 On Time
18 month report 06/01/2013 06/03/2013 Overdue/Received
two year report 11/21/2013 11/20/2013 On Time
three year report 11/21/2014 11/21/2014 On Time
four year report 11/21/2015 11/25/2015 Overdue/Received
five year report 11/21/2016 11/22/2016 Overdue/Received
six year report 11/21/2017    


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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