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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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New Enrollment Study


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General
Study Status Study Pending
Application Number /
Requirement Number
P240003 / PAS002
Date Original Protocol Accepted 11/08/2024
Date Current Protocol Accepted  
Study Name New Enrollment Study
Device Name Minima Stent System
Clinical Trial Number(s) NCT05086016 
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Study Population Neonate: 1-28 days, Infant: 29 days-2 yrs, Child: 2-12 yrs
Detailed Study Protocol Parameters
Study Objectives Single arm, prospective, non-randomized, multi-center, open-label, post approval study
To collect post-market, real-world safety and effectiveness data of the Minima Stent when used in treatment of native and post-operative congenital vascular stenoses within the aortic and pulmonary circulations, in neonates, infants, and small children.
Study Population The study population will comprise patients treated with the Minima Stent System.
Sample Size Number of subjects: Minimum 100 patients
Assumptions for sample size estimation: N/A
Number of sites: N/A
Sites location: N/A
Key Study Endpoints Safety Endpoints
Primary:
Freedom from procedure- or device-related SAEs resulting in an event listed below:
•Death
•Cardiac arrest and/or emergency ECMO cannulation
•Stroke
•Limb loss
•Vessel dissection of target lesion
•Device thrombosis/occlusion
•Cardiac perforation requiring percutaneous or open surgical intervention
•Persistent cardiac arrhythmia requiring a pacemaker
Secondary:
• Freedom from intraprocedural stent movement to non-intended location during the procedure.
• Freedom from postprocedural stent embolization or migration
• Freedom from stent fracture that led to reintervention
• Freedom from non-elective Minima Stent explant
• Freedom from procedure- or device-related SAE during re-dilation that results in the following:
o Death
o Cardiac arrest and/or emergency ECMO cannulation
o Stroke
o Limb loss
o Vessel dissection of target lesion
o Device thrombosis/occlusion
o Cardiac perforation requiring percutaneous or open surgical intervention
o Persistent cardiac arrhythmia requiring a pacemaker
Effectiveness Endpoints
Primary:
Acute device success as defined by:
•Stenosis relief, defined by stent outer diameter = 75% of the normal surrounding vessel immediately after deployment.
•Freedom from open surgical intervention required to treat Minima Stent dysfunction at implantation
Secondary:
•Peak-to-peak pressure gradient (ventricle to arterial or arterial to arterial) < 20 mmHg after stent placement, in treatment of Aortic Coarctation, when applicable.
•Successful stent re-dilation (when indicated) at re-catheterization, defined as angiographic improvement of stenosis to >50% of the normal surrounding vessel.
•Maintenance of stented vessel diameter = 50% of post implant diameter at the time of re-dilation (pre re-dilation).


New Enrollment Study Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 02/26/2025 01/28/2025 On Time
1 year report 08/28/2025    
18 month report 02/26/2026    
2 year report 08/28/2026    
3 year report 08/28/2027    


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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