First-in-human Clinical Trial to Assess Safety and Efficacy of the CardiaZn Bioresorbable Stent in Children With Pulmonary Artery Stenosis and Aortic Coarctation

This study evaluates the safety and effectiveness of the CardiaZn stent, a novel bioresorbable stent designed specifically for infants and children with congenital cardiovascular conditions. Unlike permanent metal stents, the CardiaZn stent is designed to open narrowed blood vessels and then gradually dissolve, leaving nothing permanently behind. This allows the vessel to grow naturally with the child over time. The study will enroll children under 9 years of age diagnosed with either pulmonary artery stenosis - a narrowing of the arteries that carry blood from the heart to the lungs - or aortic coarctation - a narrowing of the main artery carrying blood from the heart to the body. Both conditions currently require repeated interventions as children grow, since existing permanent stents cannot accommodate natural vessel growth. Participants will receive the CardiaZn stent during a standard cardiac catheterization procedure and will be followed for 5 years to assess vessel patency, device performance, and long-term safety outcomes.

Inclusion Criteria: * Subject is aged less than 9 years at the time of the index procedure * Subject presents with hemodynamically significant discrete aortic coarctation or pulmonary artery stenosis requiring catheter-based intervention * Subject meets angiographic eligibility criteria at the time of the index procedure as assessed by the interventional cardiologist * Subject's legally authorized representative has provided written informed consent prior to any study-related procedures * Subject's physician has determined that catheter-based intervention is clinically indicated * Target vessel anatomy is suitable for stent implantation as assessed by the operator Exclusion Criteria: * Subject has complex aortic arch hypoplasia or long segment coarctation not amenable to stent therapy * Subject has a known allergy or hypersensitivity to zinc or silver * Subject has active systemic infection at the time of the index procedure * Subject has a contraindication to cardiac catheterization or general anesthesia * Subject has previously received a stent at the target vessel segment * Subject has a comorbid condition that in the opinion of the investigator would preclude safe participation in the study or confound study results * Subject is currently enrolled in another investigational device or drug study that has not completed its primary endpoint * Subject has a life expectancy of less than 12 months in the opinion of the investigator