Clinical Research Directory

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

Sponsor: PediaStent LLC

Summary

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.

Official title: A Prospective Multi-Center, Single Arm, Open Label, Pivotal Clinical Study Designed to Assess the Safety, Performance, and Efficacy of the CardiaZn Stent in the Treatment of Pediatric Aortic Coarctation and Pulmonary Artery Stenosis

Key Details

Conditions

Interventions