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General |
Study Status |
Study Pending |
Application Number / Requirement Number |
P240003 / PAS001 |
Date Original Protocol Accepted |
08/28/2024
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Date Current Protocol Accepted |
 
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Study Name |
Continued Follow-up of the Premarket Cohort
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Device Name |
Minima Stent System
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Clinical Trial Number(s) |
NCT05086016
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General Study Protocol Parameters |
Study Design |
Prospective Cohort Study
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Data Source |
New Data Collection
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Comparison Group |
No Control
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Analysis Type |
Descriptive
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Study Population |
Neonate: 1-28 days,
Infant: 29 days-2 yrs,
Child: 2-12 yrs
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Detailed Study Protocol Parameters |
Study Objectives |
Single-arm, prospective, non-randomized, multi-center, open-label, pivotal study
Continued follow-up of premarket cohort
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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.
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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.
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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
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Follow-up Visits and Length of Follow-up |
5 years
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