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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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EVOLVE 4.5/5.0 Study


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General
Study Status Progress Adequate
Application Number P150003 S039/ PAS001
Date Current Protocol Accepted  
Study Name EVOLVE 4.5/5.0 Study
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Study Population Transit. Adolescent A (distinctively) : 18-21 yrs, Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description The objective of the EVOLVE 4.5/5.0 Study is to confirm the safety and effectiveness of SYNERGY 4.50 mm and 5.00 mm Everolimus-Eluting Platinum Chromium Coronary Stent System (SYNERGY Stent System) for the treatment of patients with atherosclerotic lesions(s) less than or equal to 28 mm in length (by visual estimate) in native coronary arteries > 4.00 mm to less than or equal to 5.00 mm in diameter (by visual estimate).
Study Population Description US patients who are acceptable candidates for treatment with a 4.50 or 5.00 mm SYNERGY stent if treated in accordance with the applicable guidelines on PCI, the SYNERGY DFU, and the Declaration of Helsinki. Sites should 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-Q-wave), 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


EVOLVE 4.5/5.0 Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 04/18/2019 04/16/2019 On Time
one year report 10/18/2019    
18 month report 04/17/2020    
two year report 10/17/2020    
three year report 10/17/2021    


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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