Balloon breakthrough: could a Drug-Coated device prevent stroke?
NCT ID NCT07542938
First seen Jun 27, 2026 · Last updated Sep 11, 2026 · Updated 2 times
Summary
This study tests a special balloon coated with medicine to open narrowed arteries in the brain and prevent strokes. About 264 people with severe artery narrowing will be treated and followed for 12 months. The goal is to see if the balloon is safe and keeps arteries open better than standard 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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About 264 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2026
- Expected to finish
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Nov 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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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. Age 18-80 years; 2. Symptomatic intracranial arterial stenosis within the past 6 months, with 70%-99% diameter stenosis on angiography (per WASID criteria); 3. Target lesion located in: intracranial segment of the internal carotid artery (C3 or above), M1/M2 segment of the middle cerebral artery, basilar artery, or intracranial segment of the vertebral artery; 4. At least one atherosclerotic risk factor (history or current hypertension, diabetes mellitus, hyperlipidemia, hyperhomocysteinemia, smoking, or alcohol consumption); 5. Reference vessel diameter adjacent to the target lesion ≥ 2 mm； 6. Baseline mRS score ≤ 2; 7. Patient or legally authorized representative understands the study purpose, voluntarily agrees to participate, provides written informed consent, and is willing and able to comply with follow-up visits. Exclusion Criteria: 1. Acute ischemic stroke within 2 weeks prior to screening; 2. Major surgery or acute myocardial infarction within 30 days prior to screening; 3. Intracranial hemorrhage (parenchymal, subarachnoid, subdural, or extradural) within 3 months prior to screening; 4. Uncontrolled hypertension despite medical therapy (systolic BP ≥ 180 mmHg or diastolic BP ≥ 110 mmHg); 5. Coexisting intracranial tumor, intracranial aneurysm requiring treatment, or arteriovenous malformation; 6. Previous stenting of the target lesion or any intracranial stenting/endovascular procedure within the past 3 months; 7. Cardioembolic stroke; 8. Stroke caused solely by perforator artery occlusion; 9. Two or more consecutive lesions with ≥ 70% stenosis in the target vessel; 10. Additional de novo or in-stent restenosis lesions (\> 70% diameter stenosis);in other intracranial arteries requiring treatment during the same session; 11. Severe calcification, extreme angulation, severe tortuosity, or other anatomical features in the target vessel that may prevent safe device delivery or retrieval; 12. Known allergy or contraindication to heparin, sirolimus (rapamycin), iodinated contrast, aspirin, clopidogrel, or local anesthetics; 13. Gastrointestinal bleeding within 6 months prior to informed consent, rendering antiplatelet therapy unsafe; 14. Platelet count \< 90 × 10⁹/L; 15. INR \> 1.5; 16. Pregnant, breastfeeding, or planning pregnancy within 1 year; 17. Life expectancy \< 1 year; 18. Participation in another drug or device clinical trial currently or planned during the study period; 19. Intracranial stenosis due to non-atherosclerotic etiology (e.g., arterial dissection, moyamoya disease, vasculitis, active arteritis, thrombosis); 20. Severe or unstable comorbidities (e.g., severe heart failure, respiratory failure, renal failure \[serum creatinine \> 3.0 mg/dL or 264 µmol/L\], severe hepatic impairment \[ALT/AST \> 3 × ULN\], active malignancy); 21. Flow-limiting dissection or residual stenosis \> 50% after pre-dilatation; 22. Any other condition that, in the investigator's judgment, makes 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.
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
15 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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上海交通大学医学院附属仁济医院
RECRUITINGShanghai, Shanghai Municipality, 200127, China
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包头市中心医院
RECRUITINGBaotou, Inner Mongolia, 014040, China
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南阳市中心医院
RECRUITINGNanyang, Henan, 473000, China
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哈尔滨医科大学附属第一医院
RECRUITINGHarbin, Heilongjiang, 150001, China
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复旦大学附属华山医院（包含总院及西院区）
RECRUITINGShanghai, Shanghai Municipality, 200040, China
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山东大学齐鲁医院
RECRUITINGJi'nan, Shandong, 250012, China
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山东省立医院（包含老院区及东院区）
RECRUITINGJi'nan, Shandong, 250021, China
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河北省人民医院
RECRUITINGShijiazhuang, Hebei, 050051, China
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河南省人民医院（包含总院及北院区）
RECRUITINGZhengzhou, Henan, 450003, China
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济南市中心医院
RECRUITINGJi'nan, Shandong, 250013, China
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福建医科大学附属协和医院
RECRUITINGFuzhou, Fujian, 350001, China
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西安交通大学第一附属医院（包含总院及港务院区）
RECRUITINGXi'an, Shaanxi, 710061, China
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郑州大学第一附属医院（包含河医院区、郑东院区、南院区）
RECRUITINGZhengzhou, Henan, 450052, China
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青岛大学附属医院
RECRUITINGQingdao, Shandong, 266003, China
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首都医科大学宣武医院
RECRUITINGBeijing, Beijing Municipality, 100053, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- New balloon coated with paclitaxel aims to keep brain arteries open
- Cholesterol control may cut stroke risk in brain artery disease
- New combo therapy shows promise in preventing stroke worsening
- New stent aims to prevent stroke in patients with clogged brain arteries
- Brain stent blood thinner study pulled before it began
- New brain stent aims to stop strokes in High-Risk patients