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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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Continued Follow-up of the Premarket Cohort


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General
Study Status Study Pending
Application Number /
Requirement Number
P240003 / PAS001
Date Original Protocol Accepted 08/28/2024
Date Current Protocol Accepted  
Study Name Continued Follow-up of the Premarket Cohort
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, pivotal study

Continued follow-up of premarket cohort
Study Population The study population was comprised of subjects with a clinically relevant pulmonary artery or aortic vascular stenosis who were indicated for treatment. For each treatment location (pulmonary artery or aortic vascular), a minimum of 10 subjects was required per the study protocol.
Sample Size 42 subjects enrolled

For the study to successfully pass, all both Safety & Efficacy Primary Endpoints must reject their null hypothesizes concurrently, using the appropriate one-sided significance level for each endpoint (2.5% and 2.5% respectively); therefore, power calculations were performed
for each hypothesis statement, based on the normal approximation to the binomial distribution, and combined using the Inclusion-Exclusion Rule (shown below), assuming the 2 endpoints are independent, to determine the power of the study at each sample
size.

P(A U B) = P(A) + P(B) - P(AB)
Where:
P(A) = ßEfficacy
P(B) = ßSafety
P(AB) = ßEfficacy x ßSafety
P(A U B) = ßEfficacy & Safety
Study Power = 1 - ßEfficacy & Safety

Using the assumptions above, analysis shows a minimum of 36 subjects will provide 90% power to meet both the primary efficacy and safety performance goals. To account for approximately 15% attrition rate, a maximum of 42 United States subjects (42=36(100%+15%)) were allowed to be implanted, prior to further authorization.
Key Study Endpoints The primary efficacy endpoint is assessed as the rate of clinical success, with the performance goal defined as a clinical success rate of greater than 77%. Clinical success was defined as:
• Stenosis relief, defined by stent outer diameter = 75% o the surrounding vessel immediately after deployment
• Freedom from open surgical intervention required to treat Minima Stent dysfunction through 6 months
• Maintenance of stented vessel diameter = 50% of post-implant diameter at 6 months; as measured using CT angiography and/or angiography.

The primary safety endpoint was assessed as the percentage of cases with freedom from procedure- or device-related SAEs resulting in an event listed below, with the performance goal defined as greater than 78% of cases:
• 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

The secondary efficacy endpoints are as follows:
• Peak-to-peak pressure gradient (ventricle to arterial or arterial to arterial) < 20 mmHg after stent placement, when applicable.
• Successful stent re-dilation (when indicated) at re-catheterization, defined as an increase in the intra stent angiographic luminal diameter of within 2 mm of the adjacent native vessel diameter immediately after re-dilation.

The secondary safety endpoints are as follows:
• Free from stent embolization or migration through 6 months.
• Free from stent fracture that led to reintervention through 6 months
• Free from non-elective Minima Stent explant at 90-days post re-dilation
• Free 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
Follow-up Visits and Length of Follow-up 5 years


Continued Follow-up of the Premarket Cohort Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 02/26/2025    
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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