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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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ODE Lead-EVOLVE Short DAPT Stu;dy


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General
Study Status Study Pending
Application Number P150003 / PAS001
Study Name ODE Lead-EVOLVE Short DAPT Stu;dy
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Historical Control
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, 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:

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 2,000 subjects will be enrolled in up to 110 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 Primary endpoint: Rate of death or MI between 3 and 15 months post-index procedure



Powered major secondary endpoints:

¿ Rate of ARC definite/probable stent thrombosis (ST) involving the SYNERGY stent between 3 and 15 months post-index procedure

¿ Rate of major bleeding (GUSTO severe/life-threatening + moderate) between 3 and 15 month post-index procedure

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.


ODE Lead-EVOLVE Short DAPT Stu;dy Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
two year report 10/01/2017 10/23/2017 Overdue/Received
three year report 10/01/2018    
four year report 10/01/2019    
five year report 09/30/2020    


Contact Us

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD
20993-0002

Phone: (301) 796-6134
Fax: (301) 847-8140
julie.unger@fda.hhs.gov

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