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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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ODE Lead-ILLUMINATE Continued Follow-Up Study


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General
Study Status Study Pending
Application Number P160049 / PAS001
Date Current Protocol Accepted  
Study Name ODE Lead-ILLUMINATE Continued Follow-Up 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 This study will evaluate the long-term safety and effectiveness of the Stellarex 035 DCB in 300 subjects from the premarket study (ILLUMINATE trial).
Study Population Description The test group is the Stellarex DCB and the control group is standard PTA.
Sample Size A minimum of 236 subjects evaluable at 24 months are required for the sample size calculations.
Data Collection The primary effectiveness endpoint is primary patency of the target lesion at 24 months. The primary safety endpoint is a composite of freedom from device- and procedure-related death at 30 days and freedom from target limb major amputation and clinically-driven target vessel revascularization (CD-TVR) at 24 months. Secondary endpoints include : (1) major adverse events (MAE), (2) clinically-driven target lesion revascularization (CD-TLR), (3) all TLR, (4) clinically-driven target vessel revascularization (CD-TVR), (5) target limb major amputation, (6) mortality, and (7) arterial thrombosis. The endpoints to be assessed at 2 and 3 years post-procedure are: (1) patency, (2) change in ankle-brachial index (ABI), (3) change in walking impairment questionnaire (WIQ), (4) change in walking distance, (5) change in Rutherford-Becker classification, and (6) change in quality of life assessment by EQ-5D questionnaire.
Follow-up Visits and Length of Follow-up 5 years


ODE Lead-ILLUMINATE Continued Follow-Up Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
one year report 07/26/2018    
two year report 07/26/2019    
three year report 07/25/2020    
four year report 07/25/2021    
five year report 07/25/2022    


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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