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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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OSPREY Iliac Continued Follow-up Study


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General
Study Status Study Pending
Application Number /
Requirement Number		 P140002 S032/ PAS001
Date Original Protocol Accepted 07/16/2026
Date Current Protocol Accepted 07/16/2026
Study Name OSPREY Iliac Continued Follow-up Study
Device Name MISAGO(TM) RX Self-expanding Peripheral Stent
Clinical Trial Number(s) NCT02793492  
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Study Population Transit.Adolescent B(as adults): 18 yrs < 22 yrs, Adult: At least 22 yrs
Detailed Study Protocol Parameters
Study Objectives The study objective is to confirm the safety and efficacy of the Misago® RX Self-expanding Peripheral Stent for use in the common and/or external iliac artery.
Study Population The target population is comprised of subjects with de novo, restenotic and/or occlusive atherosclerotic lesion(s) of the common and/or external iliac artery up to 120 mm in length with reference vessel diameters between 4.0 and 9.0 mm.
Sample Size 75 Subjects Enrolled, 64 remain in follow up.
Key Study Endpoints Co-primary Endpoint: Freedom from the composite Major Adverse Event, defined as peri-procedural related death, amputation of the target limb, and clinically driven Target Lesion Revascularization (CD-TLR) assessed at 9 months post-procedure.
Clinically driven TLR is defined as re-intervention of the target lesion in which subject has greater than or equal to 50% stenosis with worsening symptoms, or greater than or equal to 70% stenosis without symptoms. The date of the TLR is the date of the re-intervention. The primary objective will be to summarize the primary endpoint. The percentage of subjects not experiencing the MAEs (%) and the 95% Agresti-Coull confidence interval will be reported.
Follow-up Visits and Length of Follow-up 24 months


OSPREY Iliac Continued Follow-up Study Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
1 year report 07/16/2027    
2 year report 07/15/2028    
3 year report 07/15/2029    
4 year report 07/15/2030    
5 year report 07/15/2031    


Contact Us
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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