New stent aims to prevent stroke in patients with clogged neck arteries
NCT ID NCT06365697
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests a new device called the Ton-bridge carotid stent for treating carotid artery stenosis, a condition where the main arteries in the neck become narrowed, raising stroke risk. Researchers will compare it to a standard stent in 188 patients aged 18-80 who have significant blockage. The main goal is to see if the new stent is as safe and effective, looking at major problems like death, stroke, or heart attack within 30 days.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Ton-bridge carotid stent (a mesh tube placed in the neck artery to keep it open)
- What this could lead to
- If successful, this could offer a safe and effective new option for treating narrowed carotid arteries, potentially reducing the risk of stroke.
- What could go wrong
- This is a mid-stage trial with only 188 participants, so results may not apply to everyone. There are standard risks like stroke, heart attack, or death from the procedure itself.
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 188 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2024
- Expected to finish
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Oct 2026
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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18 to 80 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: * Patient is 18-80 years old and of any sex; * Patient is diagnosed with carotid atherosclerotic stenosis by imaging. The lesion site is located in the extracranial segment of carotid artery and is suitable for endovascular treatment. Patient is either symptomatic with carotid stenosis≥50% or asymptomatic with carotid stenosis≥70% as determined by digital subtraction angiography (DSA) using NASCET methodology. * Symptomatic is defined as non-disabling ischemic stroke (mRS≤2) or transient cerebral ischemia (TIA, including cerebral hemispheric neurological events and amaurosis fugax) associated with the carotid stenosis within the past 6 months. * The target vessel reference diameter ranges from 3.5mm to 9mm. * Patient has been informed of the nature of this trial, understood the purpose of this clinical investigation, and volunteered to participate and sign the informed consent form. Exclusion Criteria: * Evolving stroke within 3 months before index procedure, disabling stroke (mRS≥3) before the procedure, or massive cerebral infarction (area of infarction is \>1/3 of the ipsilateral middle cerebral artery territory) within 30 days before the procedure. * Myocardial infarction within 30 days prior to index procedure. * Severe heart, lung, liver, or renal insufficiency. * Patient has known bleeding diathesis, or contraindication to heparin or antiplatelet therapy. * Patient has a known allergy to contrast media or nickel-titanium material. * Disturbance of consciousness, dementia, or severe neurological deficits (NIHSS≥15 or mRS≥3) * Severe hypertension (Systolic blood pressure≥180mmHg and/or diastolic blood pressure≥110mmHg) difficult to be controlled. * Patient has known risk factors for embolization. * Patient has had any major surgical procedure (i.e., intraabdominal or intrathoracic surgery, any surgery or interventional procedure involving cardiac, cerebral or vascular system) within 30 days before index procedure. * Patient has had any intracranial surgery or intracranial hemorrhage within 1 year before index procedure. * Patient has other known neurological diseases such as intracranial tumor, which may confound the neurological assessments. * Intracranial aneurysm or arteriovenous malformation, which requires treatment. * Patient has other known vascular lesion requiring intervention at the same time or within 30 days after index procedure. * Patient has other carotid diseases such as vasculitis, carotid dissection, carotid aneurysm and fibromuscular dysplasia. * Ipsilateral intracranial artery severe stenosis (≥70%), occlusion or dissection; stenosis(≥50%) or occlusion of ipsilateral common carotid artery opening or brachiocephalic artery; any previously placed stent in the ipsilateral carotid artery or brachiocephalic artery; the target lesion is a restenosis after a previous carotid endarterectomy (CEA). * The target lesion vessel has intraluminal filling defect, thrombosis, occlusion or subtotal occlusion ("string sign"). * Severe tortuous anatomy or other anatomic factors that prohibit the safe placement of the catheter or stent systems. * Pregnant or lactating female. * Patient is participating in an investigational drug or device study where the primary endpoint has not yet been completed or that will clinically interfere with the endpoint of this investigation. * Other circumstances which the investigator considers unsuitable for participating in this investigation.
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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.
Contacts and locations
Locations
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Central Hospital Affiliated to Shangdong First Medical University
Jinan, Shangdong, China
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Linyi People's Hospital
Linyi, Shandong, China
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Lishui Central Hospital
Lishui, Zhejiang, China
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Qingdao Central Hospital
Qingdao, Shandong, China
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The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China
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The People's Hospital of Liaoning Province
Shenyang, Liaoning, China
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Xuanwu Hospital, Capital Medical University
Beijing, China
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Other studies related to the condition(s) this trial covers.
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