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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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New Enrollment PAS Registry

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Study Status Progress Inadequate
Application Number /
Requirement Number
P170003 / PAS002
Date Original Protocol Accepted 02/26/2018
Date Current Protocol Accepted 12/16/2021
Study Name New Enrollment PAS Registry
Device Name LUTONIX® 035 Drug Coated Balloon PTA Catheter, Model 9010
General Study Protocol Parameters
Study Design Active Surveillance
Data Source Sponsor Registry
Comparison Group Objective Performance Criterion
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Objectives To demonstrate safety and assess the clinical use and outcomes of the Lutonix DCB for treatment of dysfunctional AV fistulae located in the arm in a heterogeneous patient population in a real world clinical practice.

A prospective, global multicenter, single arm, post-approval registry study of newly enrolled patients.
Study Population Subjects presenting with clinical and hemodynamic abnormalities in arteriovenous fistulae located in the arm who meet all inclusion criteria and none of the exclusion criteria.
Sample Size A total of 213 subjects will be enrolled at a minimum of 15 and a maximum of 30 U.S. and International sites. Approximately 50% of subjects enrolled and study sites will be from the U.S.
Based on a TLPP rate of 71.4%, a non-inferiority margin of 10%, a 10% drop-out rate and one-sided exact binomial test p = 0.05, sample size of 213 provide 90% power for evaluating the primary effectiveness hypothesis comparing 61.4% PG.

Based a primary safety endpoint rate of 95% (pivotal trial), a non-inferiority margin of 6%, and one-sided exact binomial test p = 0.05, sample size of 213 will provide 95% power evaluating the primary safety hypothesis comparing to 89% PG.
Key Study Endpoints Primary Safety Endpoint:
Freedom from any serious adverse event(s) involving the AV access circuit through 30 days

Primary Effectiveness Endpoint:
TLPP through 6 months
defined as the interval following index procedure until clinically-driven reintervention of the target lesion or access thrombosis, through 6 months

Secondary Safety Endpoints:
1. Freedom from any serious adverse event(s) involving the AV access circuit through 6, 12, 18 and 24 months
2. Rate of device and procedure related adverse events assessed at 6, 12, 18 and 24 months

Secondary Effectiveness Endpoints:

1. TLPP evaluated at 12, 18 and 24 months
2. Number of reinterventions to maintain target lesion patency at 6, 12, 18 and 24 months
3. Time to loss of Target Lesion Primary Patency (i.e. time between index procedure to the first loss of patency)
4. Access Circuit Primary Patency (ACPP) evaluated at 6, 12, 18 and 24 months
5. Number of reinterventions to maintain access circuit patency at 6, 12, 18 and 24 months
6. Device, Procedural and Clinical Success
7. Abandonment of permanent access in the index extremity at 6, 12, 18 and 24 months
8. Secondary Patency of the Access Circuit at 6, 12, 18 and 24 months
9. Time to loss of target lesion secondary patency following DCB (i.e. time between first reintervention with a DCB to the next loss of patency)
Follow-up Visits and Length of Follow-up 24 months
Interim or Final Data Summary
Actual Number of Patients Enrolled 58
Actual Number of Sites Enrolled 18 sites have enrolled
Patient Follow-up Rate Rate: 79.3% (46/58)
36/39 (92.3%) completed 6- month follow-up visit
28/31 (90.3%) completed 12-month follow-up visit
24/25 (96.0%) completed 18-month follow-up visit
20/21 (95.2%) completed 24-month follow-up visit
12/58 subjects have discontinued the study (1 withdrawal, 11 died)

New Enrollment PAS Registry Reporting Schedule

Reporting Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
six month report 02/23/2018 03/01/2018 Overdue/Received
one year report 08/25/2018 08/22/2018 On Time
18 month report 02/23/2019 02/22/2019 On Time
two year report 08/25/2019 08/19/2019 On Time
three year report 08/24/2020 08/24/2020 On Time
4 year report 08/24/2021 08/20/2021 On Time
5 year report 08/24/2022 08/24/2022 On Time
66 month report 03/20/2023    
6 year report 08/24/2023    

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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