St. Louis

This research evaluates the Renata Minima Stent System in neonates, infants, and small children with vascular narrowing conditions like pulmonary artery stenosis or aortic coarctation. It is a post-approval, multi-center, open-label study conducted in the United States to monitor the devices performance and collect real-world outcome data. Participants will receive treatment with the Renata Minima Stent System. The study involves one group of patients who have been implanted with this device. Follow-up visits will occur immediately after implantation, during any re-dilation procedures, annually, and at other standard care visits as determined by the implanting physician. The study will track key data related to the device and the procedure over a period of up to 5 years post-implant. During the study, researchers will collect information at each follow-up to analyze the devices success rate at implantation and monitor for serious adverse events related to the procedure or device. They will also track outcomes like stent re-dilation success, pressure gradients, stent migration, embolization, and any need for unplanned stent removal. Participants will be observed and assessed over several years to gather comprehensive safety and performance data.