f Post-Approval Studies (PAS) Database
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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 PAS


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General
Study Status Completed
Application Number /
Requirement Number		 P150003 S055/ PAS001
Date Original Protocol Accepted 05/28/2020
Date Current Protocol Accepted  
Study Name SYNERGY PAS
Device Name SYNERGY™ XD Everolimus-Eluting Platinum Chromium Coronary Stent System (Monorail™)
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Objective Performance Criterion
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Objectives To assess the FDA requirement for safety and effectiveness of the SYNERGY 48 mm Coronary Stent System for the treatment of subjects with atherosclerotic lesion(s) > 34 mm and less than or equal to 44 mm in length (by visual estimate) in native coronary arteries greater than or equal to 2.5 mm to less than or equal to 4.0 mm in diameter (by visual estimate).
Study Population patients, including those with diabetes mellitus, with symptomatic heart disease, stable angina, unstable angina, non-ST elevation MI or documented silent ischemia due to atherosclerotic lesions in native coronary arteries from 2.50 - 4.00mm (nominal) in diameter, and > 34 mm and less than or equal to 44 mm lesion lengths
Sample Size 100
Key Study Endpoints The primary endpoint is the 12-month Target Lesion Failure (TLF) rate, defined as any ischemia-driven revascularization of the target lesion (TLR), myocardial infarction (MI, Q-wave and non–Q-wave) related to the target vessel, or cardiac death.
Follow-up Visits and Length of Follow-up 1 year follow-up
Interim or Final Data Summary
Actual Number of Patients Enrolled 100
Actual Number of Sites Enrolled 10
Patient Follow-up Rate 1 year
Final Safety Findings Two patients had a MI that was related to the target vessel
None of the patients experienced a definite or probable ST through 12 months
Final Effect Findings The trial primary endpoint was met: the rate of 12-month TLF was 4.1% in both the ITT and per-protocol population (one-sided 95% upper confidence bound of 9.1%), which was significantly less than the performance goal of 19.5% (P<0.0001)
There was a total of 5 deaths at 12-months and 1 of these was cardiac-related
The rates of technical and clinical procedural success were 100.0%
Study Strengths & Weaknesses Single arm trial with a limited sample size for confirmatory analysis.
Recommendations for Labeling Changes none


SYNERGY PAS Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
Final Report 07/27/2020 06/18/2020 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

Additional Resources

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