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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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Cont f/u of BIONICS Clinical Study


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General
Study Status Progress Adequate
Application Number P170008 / PAS001
Date Current Protocol Accepted  
Study Name Cont f/u of BIONICS Clinical 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
Study Population Description Prospective, multicenter, single-blind, two-arm 1:1 randomization (EluNIR versus Resolute)
Sample Size 1919 subjects (already enrolled)
Data Collection The primary safety and effectiveness endpoint is TLF at 12 months post-index procedure. The secondary angiographic endpoint is in-stent late lumen loss at 13-months post-index procedure. Additional clinical secondary endpoints include acute success (device, lesion, and procedure), cardiac death, target vessel MI, target lesion revascularization, MACE, target lesion failure, target vessel failure and stent thrombosis.
Follow-up Visits and Length of Follow-up 5 years
Interim or Final Data Summary
Actual Number of Patients Enrolled 1919 Patients
Actual Number of Sites Enrolled 76 Clinical sites in the US, Canada, EU and Israel
Patient Follow-up Rate Minimum of 95% follow-up rate
Final Safety Findings 12 months

The 12-month primary effectiveness was met.

Adverse event: ([EluNIR] 86.1% vs. [Resolute] 85%)

Serious Adverse event: ([EluNIR] 55% vs. [Resolute] 54.2%)
Final Effect Findings The main safety and effectives endpoint rates through 5 years in the BIONICS study are:

Target lesion revascularization (TLR): ([EluNIR] 7.8% vs. [Resolute] 6.8 %), Target lesion failure (TLF): ([EluNIR] 12.5% vs. [Resolute] 11.4%), Target vessel revascularization (TVR): ([EluNIR] 12.7% vs [Resolute] 9.3%, Target vessel failure (TVF): ([EluNIR] 18.8% vs. [Resolute] 18.0%), myocardial infraction : ([EluNIR] 11% vs. [Resolute] 10.3%), Cardiac death : ([EluNIR] 3.5% vs. [Resolute] 2.4%), Definite + probable Stent thrombosis : ([EluNIR] 1.0% vs. [Resolute] 0.9%, MACE: ([EluNIR] 17.4% vs. [Resolute] 15.8%, p = 0.46)
Study Strengths & Weaknesses This was a randomized controlled trial that met its primary endpoint. However, the trial was conducted primarily in a non-US population
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.


Cont f/u of BIONICS Clinical Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
one year report 11/28/2018 11/26/2018 On Time
two year report 11/28/2019 11/15/2019 On Time
three year/final report 12/28/2020 12/23/2020 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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