Study of the Renata Minima Stent System for Treating Pulmonary Artery Stenosis and Aortic Coarctation in Neonates, Infants, and Small Children

What this Trial Is About

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.

Minima Stent System Post- Approval Study (PAS)