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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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Synergy Megatron PAS


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General
Study Status Progress Adequate
Application Number P150003 S054/ PAS001
Date Current Protocol Accepted  
Study Name Synergy Megatron PAS
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description This is a post-market, standard of care, real-world observational study to assess the clinical outcomes of the SYNERGY XLV Coronary Stent System for the treatment of subjects with atherosclerotic lesion(s) less than or equal to 28 mm in length (by visual estimate) in native coronary arteries greater than or equal to 3.50 mm to less than or equal to 5.00 mm in diameter (by visual estimate).
Study Population Description A patient is an acceptable candidate for treatment with a SYNERGY XLV stent if treated in accordance with the applicable guidelines on PCI, the SYNERGY IFU, and the Declaration of Helsinki. Sites should follow their local standard of care and approach consecutive patients for inclusion in the trial.
Sample Size A minimum of 100 subjects will be enrolled at up to 20 US sites.
Data Collection The primary endpoint is the rate of Target Lesion Failure (TLF) rate at 12-months.

Secondary endpoints include rates of TLR, TLF, TVR, TVF, MI (Q-Wave and non-Qwave), Death (All, Cardiac, Non-Cardiac), Cardiac Death or MI, All Death or MI, All Death or MI or TVR, Stent Thrombosis (ARC Definitions) at 6-months, 12-months, 2-years, and 3-years. In addition, secondary endpoints will technical and clinical success rates.
Follow-up Visits and Length of Follow-up 3 years
Interim or Final Data Summary
Interim Safety Information Due to the early stage of the study, no interpretation, or conclusions regarding the overall safety of the study can be drawn.
Actual Number of Patients Enrolled 72
Actual Number of Sites Enrolled 10
Patient Follow-up Rate 100%
Study Strengths & Weaknesses This is an approved, single arm, multi-center observational trial designed to confirm the safety and effectiveness of the SYNERGY EVOLVE LV XLV/MEGATRON Coronary Stent System.


Synergy Megatron PAS Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 07/23/2021 07/26/2021 Overdue/Received
one year report 01/22/2022    
18 month report 07/23/2022    
two year report 01/22/2023    
three year report 01/22/2024    
four year report 01/21/2025    


Contact Us

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

Additional Resources

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