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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 Short DAPT Study


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General
Study Status Completed
Application Number P150003 / PAS001
Date Current Protocol Accepted 05/12/2017
Study Name EVOLVE Short DAPT Study
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 The EVOLVE Short DAPT clinical trial is a prospective, multicenter, single-arm study designed to assess the safety of 3-month dual antiplatelet therapy (DAPT) in subjects at high risk for bleeding undergoing percutaneous coronary intervention (PCI) with the SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System (SYNERGY Stent System).
Study Population Description Device: SYNGERGY Everolimus-Eluting Platinum Chromium Coronary Stent System



Subject considered at high risk for bleeding, defined as meeting one or more of the following criteria at the time of enrollment: =75 years of age, current anticoagulation therapy, history of major bleeding, stroke, or renal insufficiency (creatinine =2.0 mg/dl) or renal failure (dialysis dependent).



Control:



Historical data collected from subjects at high risk for bleeding receiving 12 months of DAPT

Sample Size 2,250 subjects will be enrolled in up to 120 sites worldwide in the United States, Europe, Japan, and Brazil.



Number of evaluable test subjects required in the propensity score model is 1,650 (1,500 *1.1) including additional 10% subjects accounting for model variability



Expected drop out rate due to ineligibility for 3 month DAPT in 0 to 3 months = 15%



Expected attrition rate in 3 to 15 months = 3%

Data Collection Co-Primary Endpoints: The study has two co-primary endpoints which will be assessed: (1) rate of death and myocardial infarction between 3- and 15- months and (2) rate of Academic Research Consortium (ARC) definite/probable stent thrombosis (ST) involving SYNERGY between 3 and 15 months.

Secondary Endpoint: Rate of bleeding, based upon the Bleeding Academic Research Consortium (BARC) classification (types 2, 3, and 5) between 3 and 15 months in subjects not taking chronic anticoagulation.

Follow-up Visits and Length of Follow-up All enrolled subjects are to be followed through 15 months after the index procedure. The study will be considered complete with regard to the primary endpoint after all subjects have completed 15-months follow-up.
Interim or Final Data Summary
Actual Number of Patients Enrolled 2009
Actual Number of Sites Enrolled 110
Patient Follow-up Rate 1767/2009 (88.0%) available for 15-month follow-up
Final Safety Findings Co-Primary Endpoint (1) death or MI: 5.58%

Co-Primary Endpoint (2) Academic Research Consortium (ARC) definite/probable Stent Thrombosis: 0.2%

Study Strengths & Weaknesses prospective, multicenter, single-arm study designed to assess and underserved patient population (high risk for bleeding)
Recommendations for Labeling Changes Revisions to the labeling will be recommend that provide additional information and context regarding the clinical study that was performed.


EVOLVE Short DAPT Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
two year report 10/01/2017 10/23/2017 Overdue/Received
final report 10/01/2019 01/22/2020 Overdue/Received


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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