Growth Trial: Study of the Renata Minima Stent

Study Overview
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Brief Summary
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The objective of the clinical investigation is to access clinical safety and effectiveness of the Minima Stent in neonates, infants, and young children requiring intervention for common congenital vascular stenosis (i.e., coarctation of the aorta and/or pulmonary artery stenosis) who are indicated for treatment.

Official Title
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GROWTH: A Multicenter Pivotal Study of Neonatal, Infant, and Young Child Vascular Stenoses Studying the Renata Minima Stent

Conditions
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Coarctation of the Aorta, Pulmonary Artery Stenosis

Intervention / Treatment
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* Device: Catheterized Stenting


Participation Criteria
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Eligibility Criteria
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Inclusion criteria include: The subject's legally authorized representative has been informed of the nature of the clinical investigation, agrees to its provisions, and has provided written informed consent Requiring treatment* of: native, acquired, or recurrent aortic coarctation, or native, acquired, or recurrent pulmonary artery stenosis *As defined by the patient's medical team Patency of at least one femoral vein, femoral artery, jugular vein or both carotid arteries able to accommodate the delivery system Adjacent vessel to stenosis measuring > or equal to 4 mm Exclusion criteria include: Active bloodstream infection requiring antibiotic therapy within 3 days prior to stent implantation History of or active endocarditis (active treatment with antibiotics) within 180 days prior to stent implantation Aortic or pulmonary artery aneurysm in the location targeted for treatment Body weight < 1.5 kg Anatomic location of lesion judged by the investigator to not lend to the safe placement of a stent Target vessels larger or smaller than the Minima System balloon size ranges Known genetic syndrome known to be associated with vasculopathies such as but not limited to Williams syndrome, Loeys-Dietz syndrome, etc Clinical scenario requiring that more than one vessel needs stent implantation at the time of the trial procedure. Currently participating in an investigational drug study or another device study Major or progressive non-cardiac disease resulting in a life expectancy of less than six months Known hypersensitivity to aspirin or heparin and cannot be treated with other antiplatelet and/or antithrombotic medications Known hypersensitivity to cobalt-chromium or contrast media that cannot be adequately pre-medicated
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: All treated<br>The All Treated (AT) population is defined as all subjects who signed informed consent, meet eligibility criteria and for whom a procedure was begun (defined as the initiation of vascular access with the Renata Minima system). | Device: Catheterized Stenting<br>* Catheterized stenting of vascular narrowings.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Efficacy Endpoint | The primary efficacy endpoint will be assessed as the rate of clinical success, with the performance goal defined as a clinical success rate of greater than 77%. Clinical success is defined as: Stenosis relief, defined by stent outer diameter ≥ 75% of the surrounding vessel immediately after deployment. Freedom from open surgical intervention required to treat Minima Stent disfunction through 6 months. Maintenance of stented vessel diameter ≥ 50% of post-implant diameter at 6 months; as measured using CT angiography and/or angiography. | Through 6-month follow-up Visit | 
| Primary Safety Endpoint | The primary safety endpoint will be 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 | Through 6-month follow-up Visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Arterial to arterial peak-to-peak pressure gradient to < 20 mmHg | When a pressure gradient provides a reliable hemodynamic variable (e.g., coarctation of the aorta), a reduction in ventricle to arterial or arterial to arterial peak-to-peak pressure gradient to < 20 mmHg after stent placement. | immediately after deployment | 
| Successful stent re-dilation at re-catheterization | Successful stent re-dilation (when indicated) at re-catheterization, defined as an increase in the intra stent angiographic luminal diameter within 2mm of the adjacent native vessel diameter immediately after re-dilation. | Immediately after re-dilation |