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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IDE Cohort Post Approval Study


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General
Study Status Completed
Application Number /
Requirement Number		 P170003 / PAS001
Date Original Protocol Accepted 08/25/2017
Date Current Protocol Accepted  
Study Name IDE Cohort Post Approval Study
Device Name LUTONIX® 035 Drug Coated Balloon PTA Catheter, Model 9010
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 Objectives 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 The test group is the Lutonix 035 DCB and the control group is standard PTA.
Sample Size 265 subjects
Key Study Endpoints 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
Interim or Final Data Summary
Actual Number of Patients Enrolled 285
Actual Number of Sites Enrolled 23
Patient Follow-up Rate 90.5% at 6 months
Final Safety Findings The primary safety result was 94.9% (130/137) for DCB and 95.8% (138/144) for control PTA freedom from localized or systemic serious adverse events through 30 days.
Final Effect Findings The primary effectiveness was 71.4% for DCB and 63.0% for control PTA Kaplan-Meier (KM) survival at Day 180.
Study Strengths & Weaknesses The study had adequate follow-up. It did not meet its primary effectiveness endpoint, but safety was demonstrated to be similar to the control and there was a reduction in the number of reinterventions compared to control.
Recommendations for Labeling Changes Yes


IDE Cohort Post Approval Study Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 02/23/2018 03/07/2018 Overdue/Received
Final Report 09/28/2018 11/09/2018 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

Additional Resources

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