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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 45
研究概览
简要总结
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.
详细描述
Background and Clinical Need Pulmonary artery stenosis (PAS) and aortic coarctation (CoA) are among the most common congenital cardiovascular conditions requiring catheter-based intervention in infants and children. Current standard of care involves balloon dilation and implantation of permanent metallic stents. While effective in the short term, permanent stents present a significant limitation in pediatric patients: they cannot accommodate somatic growth, necessitating repeated balloon dilations and re-interventions throughout childhood. Furthermore, permanent metallic implants preclude normal vessel remodeling, restrict MRI imaging quality, and complicate future surgical access.
The unmet clinical need is substantial. A bioresorbable stent that provides acute vessel support, maintains patency through the critical healing phase, and then completely resorbs - leaving no permanent implant - would represent a paradigm shift in the management of pediatric congenital cardiovascular stenoses.
Device Description The CardiaZn stent is a bioresorbable endovascular stent fabricated from a zinc-silver (ZnAg) alloy. Zinc is an essential trace element with well-characterized metabolic pathways, and its corrosion byproducts are biocompatible and cleared through normal physiological mechanisms. The addition of silver enhances mechanical properties including radial strength and corrosion kinetics. The device is balloon-expandable and delivered via standard cardiac catheterization technique.
The ZnAg alloy platform distinguishes CardiaZn from polymer-based bioresorbable scaffolds, which have demonstrated limitations in radial strength and degradation kinetics, and from magnesium-based platforms, which resorb too rapidly for the intended application window. The zinc-silver system is designed to provide sufficient radial support through the vessel healing phase, with a resorption timeline aligned to the biological requirements of pediatric vascular remodeling.
The device is drug-free, relying entirely on the mechanical and biological properties of the ZnAg alloy to achieve its clinical objectives. This drug-free positioning is supported by pediatric case data from magnesium-based platforms demonstrating that bioresorbable metal scaffolds can achieve clinically meaningful outcomes without pharmacological augmentation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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