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General |
Study Status |
Study Pending |
Application Number / Requirement Number |
P240003 / PAS002 |
Date Original Protocol Accepted |
11/08/2024
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Date Current Protocol Accepted |
 
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Study Name |
New Enrollment Study
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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, 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.
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Study Population |
The study population will comprise patients treated with the Minima Stent System.
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Sample Size |
Number of subjects: Minimum 100 patients Assumptions for sample size estimation: N/A Number of sites: N/A Sites location: N/A
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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).
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