New balloon coated with paclitaxel aims to keep brain arteries open
NCT ID NCT06047964
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests a special balloon catheter coated with the drug paclitaxel to treat narrowed or re-narrowed brain arteries. The balloon is inflated inside the artery to open it and release the drug, which may help prevent the artery from closing again. The trial includes 281 adults aged 18 to 80 with symptomatic intracranial atherosclerosis or restenosis after prior treatment. Researchers will measure how often the artery narrows again and track patients' disability levels over 12 months.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- paclitaxel-coated balloon catheter
- What this could lead to
- If successful, this could offer a new way to reopen narrowed brain arteries and reduce the risk of stroke in patients with intracranial atherosclerosis.
- What could go wrong
- This is an early-stage device trial without a randomized control group, so results may not confirm superiority over standard balloons. Risks include vessel injury or restenosis despite treatment.
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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281 people
The number who actually took part.
- Started
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Mar 2023
- Expected to finish
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Sep 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: 1. Aged 18 to 80 years old (including boundary value), gender is not limited; 2. The target lesion of the patient is a symptomatic intracranial atherosclerotic stenosis lesion (applicable to Sub-study A only) or restenosis lesions after interventional therapy (applicable only to Sub-study B); 3. Symptomatic intracranial arterial stenosis (intracranial segment of internal carotid artery (Petrous segment and above), middle cerebral artery, intracranial segment of vertebral artery, basilar artery, etc.) within 6 months, the degree of stenosis of the diseased artery is between 70% and 99% (WASID method); 4. Patients with symptoms occurring more than once (symptoms refer to stroke or transient ischemic attacks) after intensive drug therapy of internal medicine (including antiplatelet therapy, antihypertensive therapy, hypoglycemic therapy and lipid-lowering therapy); 5. The intracranial arterial stenosis lesion to be treated is a single lesion; 6. Patients with at least 1 risk factor for intracranial atherosclerotic plaque, including previous or existing hypertension, hyperlipidemia, diabetes, smoking; 7. Preoperative mRS ≤ 2, and NIHSS≤8; 8. Patients whose life expectancy is greater than 12 months as assessed by the investigator. 9. Patients or their guardians can understand the trial purpose, voluntarily participate in and sign the informed consent form, and can accept follow-up visits. Exclusion Criteria: 1. Severe calcification in the target vessel, severe distortion of the target vessel or anatomical factors that make it hard for interventional devices to be in place; 2. Ischemic symptoms are only associated with branch events; 3. Severe stenosis or occlusion of tandem extracranial or intracranial vessels at the proximal or distal end of the target vessel; 4. Angioplasty or stenting procedures is planned for extracranial vascular lesions with tandem intracranial vessels; 5. History of endarterectomy in the extracranial segment of carotid artery and vertebral artery within 30 days; 6. The target vessel has previously been treated with stenting or angioplasty or other mechanical devices (applicable to Sub-study A only); the target vessel previously treated with drug-coated balloon expansion (applicable only to Sub-study B); 7. Acute or subacute intraluminal thrombosis is found in the target vessel; 8. Imaging shows an infarct size \> 1/2 of the target vessel's supply area; 9. Patients with intracranial stenosis combined with aneurysm, intracranial tumor or intracranial vascular malformation, or intracranial arterial spasm without significant stenosis; 10. Intracranial hemorrhage (cerebral intraparenchymal hemorrhage, massive subarachnoid hemorrhage, and subdural/epidural hemorrhage) within 3 months; 11. Acute or subacute ischemic stroke occurring within 2 weeks; 12. Non-atherosclerotic stenosis, such as arterial dissection, Moyamoya disease, vasculitis, radiation-induced vasculopathy, or fibromuscular dysplasia; 13. There are cardiogenic stroke or risk factors that may contribute to cardioembolism, such as fibrillation, left ventricular thrombosis or myocardial infarction within 6 weeks,; 14. Patients with abnormal coagulation function or bleeding tendency (e.g., international normalized ratio (INR) \> 1.5); 15. Patients with known hypersensitivity to iodine contrast medium, paclitaxel, or iopromide; 16. Any of the following abnormal laboratory test results within 7 days prior to the interventional procedure: * White blood cell (WBC) count \< 3 × 10\^9/L * Neutrophil count \< 1.0 × 10\^9/L * Platelet count \< 100 × 10\^9/L * ALT or AST \> 3 × upper limit of normal (ULN) * Serum creatinine \> 3.0 mg/dL; 17. Lactating females, or females of childbearing potential with a positive serum pregnancy test result; 18. The investigator judges that the patient has a severe medical condition that may affect protocol compliance (e.g., severe infection, severe chronic obstructive pulmonary disease \[COPD\], malignant tumor, dementia, psychiatric illness, or uncontrolled severe hypertension, defined as systolic blood pressure \> 180 mmHg or diastolic blood pressure \> 110 mmHg, etc.); 19. Patients who are participating in clinical trials of other drugs or devices; 20. Blood flow-limiting dissection or residual stenosis \> 50% after pre-dilation; 21. Other conditions that the investigator deems the patient unsuitable for enrollment.
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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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First Hospital of Shanxi Medical University
Taiyuan, Shanxi, China
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Jining First People's Hospital
Jining, Shandong, China
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Nanyang Central Hospital
Nanyang, Henan, China
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Renji Hospital, Shanghai Jiaotong University, School of Medicine
Shanghai, Shanghai Municipality, China
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The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China
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The First Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
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The First Hospital of Jilin University
Changchun, Jilin, China
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The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
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Xuanwu Hospital, Capital Medical University
Beijing, Beijing Municipality, 100000, China
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