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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
42
Catheterized stenting of vascular narrowings.
Children's Hospital Los Angeles
Los Angeles, California, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
Boston Children's
Boston, Massachusetts, United States
Cincinnati Children's Hospital
Cincinnati, Ohio, United States
Number of Participants Demonstrating Clinical Success at 6 Months
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.
Time frame: Through 6-month follow-up Visit
Number of Participants With Freedom From Serious Adverse Events at 6 Months
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
Time frame: Through 6-month follow-up Visit
Number of Patients With Arterial to Arterial Peak-to-peak Pressure Gradient of < 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.
Time frame: 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.
Time frame: Immediately after re-dilation
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Nationwide Children's
Columbus, Ohio, United States
Le Bonheur Children's
Memphis, Tennessee, United States
Seattle Children's Hospital
Seattle, Washington, United States
Number of Patients With Freedom From Stent Embolization or Migration at 6 Months
Freedom from stent embolization or migration through 6 months.
Time frame: 6 months
Number of Patients With Freedom From Stent Fracture at 6 Months
Freedom from stent fracture that led to reintervention through 6 months
Time frame: 6 months
Number of Patients With Freedom From Non-elective Minima Stent Explant at 90-days Post Re-dilation
Freedom from non-elective Minima Stent explant at 90-days post re-dilation procedure
Time frame: 90 days post re-dilation
Number of Patients With Freedom From Procedure- or Device-related SAE During Re-dilation
Freedom from procedure- or device-related SAE during re-dilation that results in the following: * 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
Time frame: Immediately after re-dilation