Symptomatic Intracranial Atherosclerotic Stenosis
Conditions
Interventions
Test group: Intracranial Drug-Coated Balloonr (Medeliver) Dilation Angioplasty
Control Group:Intracranial Balloon (Diveroad) Dilation Angioplasty
Sponsors
Xuanwu Hospital, Capital Medical University
Huashan Hospital Affiliated to Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
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
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 1.5; 16. Pregnant, breastfeeding, or planning pregnancy within 1 year; 17. Life expectancy 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Composite of target lesion restenosis, recurrent stroke in the target vessel territory, or death from any cause within 12 months post-procedure.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of recurrent stroke (ischemic or hemorrhagic) in the target vessel territory or death within 30 days and 6 months post-procedure;Device success rate;Procedural success rate;Modified Rankin Scale (mRS) score at 30 days, 6 months, and 12 months post-procedure;Target lesion binary restenosis rate at 6 months post-procedure;Incidence of any stroke or all-cause death within 30 days, 6 months, and 12 months post-procedure; | — |
Countries
China
Contacts
Public ContactFei Chen, Su Jiabin
Xuanwu Hospital, Capital Medical University Huashan Hospital Affiliated to Fudan University
Outcome results
None listed