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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Lutonix Long Lesion SFA Cont f/u study

General
Study Status	Completed
Application Number / Requirement Number	P130024 S009/ PAS003
Study Name	Lutonix Long Lesion SFA Cont 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	Sponsor Registry
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 and2 years from the following: index limb amputation and (above or below the ankle) and index limb re-intervention and (2) primary patency at 1 year and 2 years
Follow-up Visits and Length of Follow-up	2 years yearly
Interim or Final Data Summary
Actual Number of Patients Enrolled	125 DCB Subjects (118) Control Subjects (7)
Actual Number of Sites Enrolled	14
Patient Follow-up Rate	DCB Subjects 89.0% (105/118) Lost to follow up plus withdrew from study.
Final Safety Findings	The primary safety endpoint for the DCB group was 78.7%% (85/108) [69.8, 86.0] and was defined as the composite of freedom from all-cause peri-procedural (less than or equal to 30 day) death and freedom at 1 year from the following: index limb amputation (above or below the ankle) and index limb re-intervention.
Final Effect Findings	The primary effectiveness endpoint for the DCB group was DCB group: 58.3% (60/103) [48.1, 67.9] and represents primary patency at 12 months. Primary Patency is defined as Freedom from Clinically-Driven TLR and from Binary Restenosis.
Study Strengths & Weaknesses	The strengths of the study include looking at the long lesion length indication and the extended safety follow up. Study weaknesses include the small sample size and lack of control group.
Recommendations for Labeling Changes	No

Lutonix Long Lesion SFA Cont f/u study Reporting Schedule

Reporting Schedule	Report Date Due	FDA Receipt Date	Applicant's Reporting Status
one year report	02/07/2018	03/07/2018	Overdue/Received
final report	02/07/2019	04/16/2019	Overdue/Received

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