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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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PAS 1 (Extended Follow-up Study)

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Study Status Completed
Application Number P130024 / PAS001
Date Current Protocol Accepted 11/28/2017
Study Name PAS 1 (Extended Follow-up Study)
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source Sponsor Registry
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 Prospective cohort study, continued follow-up of premarket cohorts and LEVANT 2 Safety Registry subjects
Study Population Description Patients treated with the Lutonix DCB for stenosis of the femoropopliteal artery
Sample Size 657 DCB subjects from the LEVANT 2 Safety Registry

372 DCB subjects from the LEVANT 2 Pivotal IDE study

160 PTA controls from the LEVANT 2 Pivotal IDE study

The assumption is that results at 2 years will be proportionally similar in DCB subjects and controls to what

they were in the pivotal IDE study. The PAS study will have a much larger sample size and therefor greater power than that of the pivotal IDE study.
Data Collection Primary effectiveness: Primary patency of the target lesion

at 24 months

Primary safety: Composite freedom for all cause

perioperative (within 30 days), index limb amputation (2

years), index limb re-intervention (2 years), and index limbrelated death (2 years)

Secondary endpoints: Individual components of the primary

safety endpoint, device- and drug-related adverse events,

all-cause death, major vascular complications, target lesion

revascularization, and Rutherford classification
Follow-up Visits and Length of Follow-up 5 years Clinical follow-up, including Duplex Ultrasound (DUS) will be

done at 6 months, 12 months, and 24 months. Telephone

f/u will be done at 1 month, 3, 4, and 5 years.
Interim or Final Data Summary
Actual Number of Patients Enrolled Actual number of subjects enrolled:

DCB Subjects (1029)

Control Subjects (160)

This includes: LEVANT 2 Safety Registry patients (n=657), LEVANT 2 randomized DCB (n=316) and

LEVANT 2 randomized roll-in (n=56) compared against the results from the LEVANT 2 randomized

control PTA (n=160).
Actual Number of Sites Enrolled 74
Patient Follow-up Rate DCB Subjects 86% (143/1029)

Control Subjects 84% (26/160)

Lost to follow up plus withdrew from study.
Final Safety Findings The composite of freedom from all-cause perioperative death (=

30 days) and index limb amputation (including above or below the knee), index limb reintervention,

or index limb related death through 24 months was 74.7% (674/902) for the DCB group

and 67.1% (94/140) for the PTA group. The DCB group has a higher freedom from the composite

safety endpoint rate of 6.4% through the 24 months follow-up.
Final Effect Findings Primary patency of the target lesion at 24 months was

54.5% (458/841) for the DCB group and 47.2% (60/127) for the control group. The DCB group

demonstrated a higher rate of primary patency, approximately 6.4%, over the PTA group throughout 24

Study Strengths & Weaknesses The strengths of the study include randomization against an appropriate control and adequate and

extended follow up. Study weaknesses include increase mortality for the test device versus control after

two years in the randomized patients
Recommendations for Labeling Changes yes

PAS 1 (Extended Follow-up Study) Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
one year report 10/09/2015 10/09/2015 On Time
two year report 10/08/2016 10/11/2016 Overdue/Received
three year report 10/08/2017 10/11/2017 Overdue/Received
Final Report 02/28/2019 03/18/2019 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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