Post-Approval Studies (PAS) Database

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

General
Study Status	Completed
Application Number / Requirement Number	P130024 S009/ PAS002
Study Name	SFA ISR IDE Continued f/u study
Device Name	LUTONIX 035 DRUG COATED BALLOON PTA CATHETER
Clinical Trial Number(s)	NCT01864278
General Study Protocol Parameters
Study Design	Prospective Cohort Study
Data Source	New Data Collection
Comparison Group	No Control
Analysis Type	Descriptive
Study Population	Adult: At least 22 yrs
Detailed Study Protocol Parameters
Study Objectives	Continued follow-up
Study Population	DCB
Key Study Endpoints	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 yearly
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 Reporting Schedule

Reporting Schedule	Report Date Due	FDA Receipt Date	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

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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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• Guidance Document: "Procedures for Handling Post-Approval Studies Imposed by PMA Order"
• PAS Program Background