New dissolving stent could spare kids repeated heart surgeries
NCT ID NCT07628101
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This trial tests a new type of stent that dissolves over time for children under 9 with narrowed arteries in or near the heart. The stent opens the vessel and then gradually disappears, allowing the artery to grow naturally. The study will enroll 45 children and follow them for 5 years to see if the stent is safe and works better than permanent stents.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- CardiaZn bioresorbable stent (zinc-silver alloy)
- What this could lead to
- If it works, this could provide a one-time treatment for narrowed arteries in children, avoiding repeated surgeries and allowing vessels to grow naturally.
- What could go wrong
- This is an early pivotal trial with only 45 children, so results may not apply to all. Risks include vessel damage, stent clotting, or the stent not dissolving as planned.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 45 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Oct 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2031
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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Up to 8 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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