Growth Trial: Study of the Renata Minima Stent
- Conditions
- Coarctation of the AortaPulmonary Artery Stenosis
- Interventions
- Device: Catheterized Stenting
- Registration Number
- NCT05086016
- Lead Sponsor
- Renata Medical
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 42
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description All treated Catheterized Stenting 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).
- Primary Outcome Measures
Name Time Method Number of Participants Demonstrating Clinical Success at 6 Months 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 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 Outcome Measures
Name Time Method Number of Patients With Arterial to Arterial Peak-to-peak Pressure Gradient of < 20 mmHg immediately after deployment 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.
Successful Stent Re-dilation at Re-catheterization Immediately after re-dilation 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.
Number of Patients With Freedom From Stent Embolization or Migration at 6 Months 6 months Freedom from stent embolization or migration through 6 months.
Number of Patients With Freedom From Stent Fracture at 6 Months 6 months Freedom from stent fracture that led to reintervention through 6 months
Number of Patients With Freedom From Non-elective Minima Stent Explant at 90-days Post Re-dilation 90 days post re-dilation Freedom from non-elective Minima Stent explant at 90-days post re-dilation procedure
Number of Patients With Freedom From Procedure- or Device-related SAE During Re-dilation Immediately after 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
Trial Locations
- Locations (7)
Cincinnati Children's Hospital
🇺🇸Cincinnati, Ohio, United States
Le Bonheur Children's
🇺🇸Memphis, Tennessee, United States
Children's Hospital Los Angeles
🇺🇸Los Angeles, California, United States
Boston Children's
🇺🇸Boston, Massachusetts, United States
Cedars-Sinai Medical Center
🇺🇸Los Angeles, California, United States
Nationwide Children's
🇺🇸Columbus, Ohio, United States
Seattle Children's Hospital
🇺🇸Seattle, Washington, United States