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|
| General |
| Study Status |
Ongoing |
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
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| 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.
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| 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
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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).
|
| Interim or Final Data Summary |
| Interim Results |
Safety Results: N/A
Effectiveness Results: N/A
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| Actual Number of Patients Enrolled |
4
|
| Actual Number of Sites Enrolled |
Following protocol approval, 15 sites were recruited to take part in the Minima Post-Approval Study. The first site completed activation activities on April 8, 2025 and there is only one site pending activation as of August 27, 2025. The last site is only pending IRB approval and is anticipating approval within the next week. This site, like the others, began site initiation activities in November of 2024 following Protocol Approval and experienced numerous delays within their site due to new processes and resourcing issues. The 14 other sites have completed IRB Approvals and are able to enroll patients.
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| Patient Follow-up Rate |
N/A
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