Dissolving iron stent offers hope for aortic narrowing
NCT ID NCT07316855
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a new type of stent made from iron that slowly dissolves in the body. It is designed to treat coarctation of the aorta, a condition where the main artery from the heart is narrowed. The study will enroll 10 people aged 1 to 60 to see if the stent is safe and effective at keeping the artery open.
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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 10 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2024
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
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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1 year to 60 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.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Patient must between 1 and 60 years old Patients being clinically diagnosed with CoA or patients with post-operative anastomotic stenosis after CoA surgery,meanwhile meeting one of the following conditions: A:Pressure gradient of Carctation in a calm state. B:The degree of aortic stenosis is not less than 50% (degree of Carctation Of the Arota = (diameter of adjacent normal segment of blood vessel - residual vessel lumen diameter of stenotic segment) * diameter of adjacent normal segment of blood vessel×100% ) C:Peak velocity of echocardiographic Doppler in the CoA≥2.5m/s 2. The patients and their families have high compliance, sign the informed consent and willing to undergo 1-year follow-ups and related examinations. 3. The patient's expected lifespan is more than one year after successful treatment with the stent. 4. Reference vessel (diameter of the adjacent normal segment vessel ) diameter:4-16mm Exclusion Criteria: 1. Patients with a history of iron overload or iron disorder, such as hereditary hemochromatosis, etc. 2. Patients with cardiopulmonary function that cannot tolerate surgery, such as severe heart failure (NYHA Grade III and above) that cannot be controlled by active medical treatment. 3. Patients with known allergy to contrast agent, iron and its degradation products. 4. Patients with hemorrhagic disorders 5. Patients with contraindications on antiplatelet agents and anticoagulant therapy. 6. Patients with thrombosis at the vascular wall of target lesion and the distal or proximal location of the lesion. 7. Patients with known severe renal or hepatic insufficiency, which are unsuitable for index procedure 8. Target lesion to be treated where stent was implanted previously. 9. Patients with severe stenosis or excessive tortuosity in the targeted vessel, or anatomical abnormalities, which predict the device will have difficulty reaching the target lesion. 10. Other conditions that are unfavorable for stent delivery or balloon expansion. 11. Patient who have already participated in another clinical trial, and have not yet completed or withdrawn within 3 months before the screening period of this trial. 12. Patients who are not suitable for participating the trial as per investigator judgement.
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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 places running it
1 site. The list below names each one and where it is.
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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.
Contacts and locations
Locations
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Fuwai Central China Cardiovascular Hospital
RECRUITINGZhengzhou, Henan, 450000, China
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