New brain stent aims to stop strokes in High-Risk patients
NCT ID NCT05757505
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a new stent (a small mesh tube) placed in brain arteries to prevent strokes in people whose arteries are narrowed by plaque. It includes 200 adults aged 18-75 who have had a stroke or mini-stroke despite medication. The main goal is to see if the stent is safe and works as well as existing treatments, with follow-up for up to 2 years.
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 200 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2023
- Expected to finish
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Dec 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 75 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: * Age 18-75; * Subjects with symptomatic intracranial atherosclerotic stenosis who do not respond to antiplatelet therapy or have poor compensation of collateral circulation and hypoperfusion in the offending vessel blood supply; * The last onset time of TIA is not limited or the last onset of ischemic stroke is more than 2 weeks; * The lesion is confirmed to be located in intracranial large arteries, including intracranial segment of the internal carotid artery, middle cerebral artery, intracranial segment of vertebral artery and the basilar artery; * Target vessel diameter≥2.0mm and ≤4.5mm, lesion length ≤33mm; * Stenosis degree of intracranial arteries≥70% and ≤99% measured by intracranial angiography (WASID method); * Intracranial artery stenosis which requiring interventional treatment is a single lesion; * Subjects have at least 1 atherosclerotic plaque risk factor including hypertension, diabetes mellitus, hyperlipidemia, hyperhomocysteinemia, coronary heart disease, obesity, and smoking history; * mRS≤2 before enrollment; * Voluntarily participate in this study and sign the informed consent form, can complete examinations and follow-ups in accordance with the requirements of the protocol during the clinical trial. Exclusion Criteria: * Intracranial arterial stenosis caused by non-atherosclerotic lesions: such as arterial dissection, moyamoya disease, vasculitis, active arteritis, etc.; * Preoperative MRI shows only perforator infarction in the target lesion; * Preoperative CT or MRI indicates the presence of post-infarct hemorrhagic transformation in the target vascular, or a history of subarachnoid, subdural, and epidural hemorrhage within 30 days before procedure, or the presence of untreated chronic subdural hematoma (≥5mm); * Severe calcification of target vessels; or target vessel tortuosity or other reasons will make experimental device difficult to reach the target lesion position; * There is more than 70% stenosis in the distal intracranial large vessels or proximal intracranial and extracranial large vessels of the target vessels, and the presence of unidentified responsible lesions; * Subjects have a major surgery within 30 days before procedure or intend to be hospitalized for other procedure within 6 months after procedure; * Intracranial tumors or intracranial arteriovenous malformations, or distal and proximal target vessels combined with aneurysms; * The target lesion has a history of stent implantation; * It is suspected that there is severe allergy or contraindication to aspirin, clopidogrel, heparin, contrast media, nitinol and other drugs and devices related to endovascular therapy; * There is an underlying source of cardiac thrombus, such as atrial fibrillation, left ventricular thrombus, myocardial infarction within 30 days; * Subjects with an INR \> 1.5 or the presence of nonmodifiable bleeding factors; * Medically uncontrolled severe hypertension (systolic blood pressure \> 180 mmHg or diastolic blood pressure \> 110 mmHg); * Severe comorbid conditions or unstable conditions, such as severe heart failure, pulmonary failure, or renal failure (serum creatinine \>3.0 mg/dL (264μmol/L)), severe liver insufficiency (ALT or AST \>3 times normal), and malignancy; * Life expectancy is less than two years; * Women who are pregnant or breastfeeding; * Subjects unable to complete follow-up due to cognitive impairment, mood disorder, or mental illness; * Subjects who are enrolled in other clinical trials of drugs/devices and have not yet met the primary endpoint; * Other circumstances which investigators do not consider are appropriate for intracranial stent treatment.
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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
13 sites. 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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Baotou City Central Hospital
RECRUITINGBaotou, Neimenggu, China
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Changhai Hospital of Shanghai
NOT_YET_RECRUITINGShanghai, China
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First Affiliated Hospital of Kunming Medical University
NOT_YET_RECRUITINGKunming, Yunnan, China
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Hangzhou First People's Hospital
RECRUITINGHangzhou, Zhejiang, China
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Jiangxi Provincial People's Hospital
RECRUITINGNanchang, Jiangxi, China
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Nanjing Drum Tower Hospital
NOT_YET_RECRUITINGNanjing, Jiangsu, China
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Ningbo First Hospital
RECRUITINGNingbo, Zhejiang, China
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Shanghai Fourth People's Hospital
RECRUITINGShanghai, China
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The First Affiliated Hospital of Dalian Medical University
RECRUITINGDalian, Liaoning, China
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The First Affiliated Hospital of Henan Science & Technology University
NOT_YET_RECRUITINGLuoyang, Henan, China
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The First Hospital of Jilin University
RECRUITINGChangchun, Jilin, China
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Tongji Hospitai of Tongji University
NOT_YET_RECRUITINGShanghai, China
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Zhongnan Hospital of Wuhan University
NOT_YET_RECRUITINGWuhan, Hubei, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Balloon treatment tested against drugs for stroke risk from narrowed brain arteries
- Detailed MRI scans could reveal which brain plaques trigger strokes
- After stroke, a balloon or a stent? trial tests which rescue opens blocked brain arteries better
- Can a Cholesterol-Lowering shot reverse brain artery blockages?
- New balloon coated with paclitaxel aims to keep brain arteries open
- Balloon breakthrough: could a Drug-Coated device prevent stroke?