GROWTH: A Multicenter Pivotal Study of Neonatal, Infant, and Young Child Vascular Stenoses Studying the Renata Minima Stent
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Coarctation of the Aorta
- Sponsor
- Renata Medical
- Enrollment
- 42
- Locations
- 7
- Primary Endpoint
- Number of Participants Demonstrating Clinical Success at 6 Months
- Status
- Active, Not Recruiting
- Last Updated
- last year
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Number of Participants Demonstrating Clinical Success at 6 Months
Time Frame: Through 6-month follow-up Visit
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.
Number of Participants With Freedom From Serious Adverse Events at 6 Months
Time Frame: Through 6-month follow-up Visit
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
Secondary Outcomes
- Number of Patients With Arterial to Arterial Peak-to-peak Pressure Gradient of < 20 mmHg(immediately after deployment)
- Successful Stent Re-dilation at Re-catheterization(Immediately after re-dilation)
- Number of Patients With Freedom From Stent Embolization or Migration at 6 Months(6 months)
- Number of Patients With Freedom From Stent Fracture at 6 Months(6 months)
- Number of Patients With Freedom From Non-elective Minima Stent Explant at 90-days Post Re-dilation(90 days post re-dilation)
- Number of Patients With Freedom From Procedure- or Device-related SAE During Re-dilation(Immediately after re-dilation)