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U.S. Department of Health and Human Services

Post-Approval Studies (PAS) Database

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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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ILLUMINATE Continued Follow-Up Study

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Study Status Completed
Application Number P160049 / PAS001
Date Current Protocol Accepted  
Study Name 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
Interim or Final Data Summary
Actual Number of Patients Enrolled 300
Actual Number of Sites Enrolled 43
Patient Follow-up Rate 86.3% at 5 years
Final Safety Findings Major adverse events, as well as all-cause mortality were similar between treatment
arms through 5 years.
Final Effect Findings Primary patency was assessed through 3 years, showing similar outcomes at this point.
Similar outcomes were also demonstrated for clinically-driven target lesion
revascularization through 5 years.
Study Strengths & Weaknesses Strengths: The study was a prospectively designed randomized controlled trial with
appropriate oversight.
Weakness: A higher rate of missing data was present for 5 year follow up.
Recommendations for Labeling Changes Labeling should be updated to include 5 year clinical data

ILLUMINATE Continued Follow-Up Study Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
one year report 07/26/2018 07/26/2018 On Time
two year report 07/26/2019 07/30/2019 Overdue/Received
interim report 12/11/2019 12/11/2019 On Time
three year report 07/26/2020 07/28/2020 Overdue/Received
final report 07/26/2021 06/30/2021 On Time

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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