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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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SFA ISR IDE Continued f/u study

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Study Status Completed
Application Number P130024 S009/ PAS002
Study Name SFA ISR IDE Continued f/u study
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description Continued follow-up
Study Population Description DCB
Data Collection the composite of freedom from all-cause peri-procedural (=30 day) death and freedom at 1 year and 2 years from index limb amputation (above or below the ankle), index limb re-intervention, and index-limb-related death and (2) primary patency at 1 year and 2 years
Follow-up Visits and Length of Follow-up 3 years

Interim or Final Data Summary
Actual Number of Patients Enrolled 82

DCB Subjects (53)

Control Subjects (29)
Actual Number of Sites Enrolled 20
Patient Follow-up Rate Missing data (lost + withdrew) was 9.4%% (5/53) in the DCB arm and 20.7% (6/29) in the PTA arm.
Final Safety Findings At 12 months (365 days), the KM estimate of primary safety was 73.1% in the DCB group and 64.0% in the PTA group. At 36 months, the KM estimate of primary safety was 54.4% in the DCB group and 43.6% in the PTA group. At 36 months, the KM estimate of freedom

from all cause death for the DCB arm was 88.1% for the DCB arm and 87.8% for the PTA arm.
Final Effect Findings The primary patency at 12 months by KM estimate was 67.0% in the DCB arm and 49.5% in the PTA arm. At 24 months the primary patency was 28.9% in the DCB group and 31.0% in the PTA group by KM estimate.
Study Strengths & Weaknesses The strengths of the study include looking at the ISR indication and the extended safety follow up. Study weaknesses include the small sample size unbalanced randomization.
Recommendations for Labeling Changes Yes

SFA ISR IDE Continued f/u study Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
interim report 10/11/2017 10/11/2017 On Time
one year report 02/07/2018 02/26/2018 Overdue/Received
final report (3 yr) 06/15/2019 06/12/2019 On Time

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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