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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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EVOLVE 4.5/5.0 Study


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General
Study Status Ongoing
Application Number /
Requirement Number		 P150003 S039/ PAS001
Date Original Protocol Accepted 03/29/2019
Date Current Protocol Accepted  
Study Name EVOLVE 4.5/5.0 Study
Device Name SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System
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 Objectives 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 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.
Key Study Endpoints 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
Interim or Final Data Summary
Interim Results The study is still completing long-term follow up after completing the initial 12-month endpoint. However, review of the current data does not raise any concerns regarding the safety or efficacy of the device.
Actual Number of Patients Enrolled 100
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 4.50 mm and 5.00 mm Coronary Stent System.


EVOLVE 4.5/5.0 Study Reporting Schedule

Reporting 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 10/16/2019 On Time
18 month report 04/17/2020 04/21/2020 On Time
two year report 10/17/2020 10/15/2020 On Time
3 year report 10/17/2021 10/14/2021 On Time
4 year report 10/17/2022 10/14/2022 On Time
5 year report 10/17/2023 10/16/2023 On Time
final report 02/15/2024 02/15/2024 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

Additional Resources

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