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

NCT07628101 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2026-06-04

No results posted yet for this study

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.

Conditions

  • Aortic Coarctation, Pulmonary Artery Stenosis

Interventions

DEVICE

CardiaZn Bioresorbable Stent

The CardiaZn stent is a balloon-expandable bioresorbable endovascular stent fabricated from a zinc-silver (ZnAg) alloy. Zinc is an essential trace element with well-characterized metabolic pathways and biocompatible corrosion byproduct profile. The addition of silver enhances radial strength and optimizes corrosion kinetics for the intended resorption timeline. The device is delivered via standard cardiac catheterization technique under fluoroscopic guidance and is designed to provide acute mechanical support of the stenotic vessel segment following balloon dilation, then gradually resorb completely over time leaving no permanent implant. The device is drug-free.

Sponsors & Collaborators

  • PediaStent LLC

    lead INDUSTRY

Principal Investigators

  • Daniel Levi, MD · University of California, Los Angeles

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
8 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-10-31
Primary Completion
2031-10-31
Completion
2031-12-31
FDA Device
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07628101 on ClinicalTrials.gov