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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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IMPERIAL Continued f/u study


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General
Study Status Progress Adequate
Application Number P180011 / PAS001
Date Current Protocol Accepted  
Study Name IMPERIAL Continued f/u study
General Study Protocol Parameters
Study Design Randomized Clinical Trial
Data Source New Data Collection
Comparison Group Concurrent Control
Analysis Type Analytical
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description Continued follow-up of premarket cohort; RCT
Study Population Description Test: Eluvia DES

Control: Zilver PTX DES

Sample Size 485
Data Collection Premarket:

The primary safety hypothesis to be tested is that the 12-month MAE-free rate in subjects treated with ELUVIA is non-inferior to subjects treated with Zilver PTX by a margin of -10% (negative value) at one-sided significance level of 5%.



The primary effectiveness hypothesis to be tested is that the 12-month primary patency in subjects treated with ELUVIA is non-inferior to subjects treated with Zilver PTX by a margin of -10% (negative value) at one-sided significance level of 5%.



PAS:



Above endpoints at 24 months (descriptively).

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


IMPERIAL Continued f/u study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 03/19/2019 03/18/2019 On Time
one year report 09/18/2019    
18 month report 03/18/2020    
two year report 09/17/2020    
three year report 09/17/2021    


Contact Us

Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

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