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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-IDE Cohort Post Approval Study

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Study Status Study Pending
Application Number P170003 / PAS001
Study Name ODE Lead-IDE Cohort Post Approval Study
General Study Protocol Parameters
Study Design Randomized Clinical Trial
Data Source New Data Collection
Comparison Group Concurrent Control
Analysis Type Analytical
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description This study will evaluate the long-term safety and effectiveness of the Lutonix 035AV Drug Coated Balloon Catheter (Lutonix 035 DCB) in the remaining 265 subjects from the premarket study.
Study Population Description The test group is the Lutonix 035 DCB and the control group is standard PTA.
Sample Size 265 subjects
Data Collection The primary effectiveness endpoint is target lesion primary patency (TLPP) through 24 months. The primary safety endpoint is freedom from any serious adverse event(s) involving the AV access circuit through 24 months. Additional endpoints to be assessed through 24 months post-procedure are: (1) access circuit primary patency (ACPP), (2) device, procedural, and clinical success, (3) abandonment of permanent access in the index extremity, (4) number of interventions required to maintain access circuit patency, (5) number of interventions required to maintain target lesion patency, and (6) rate of device and procedure related adverse events.
Follow-up Visits and Length of Follow-up 2 years

ODE Lead-IDE Cohort Post Approval Study Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
six month report 02/23/2018    
one year report 08/25/2018    
18 month report 02/23/2019    
two year report 08/25/2019    

Contact Us

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

Phone: (301) 796-6134
Fax: (301) 847-8140

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