Medeliver Intracranial Drug Coated Balloon Catheter for Symptomatic Intracranial Atherosclerotic Stenosis

Inclusion criteria

• Age 18-80 years;
• Symptomatic intracranial arterial stenosis within the past 6 months, with 70%-99% diameter stenosis on angiography (per WASID criteria);
• 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;
• At least one atherosclerotic risk factor (history or current hypertension, diabetes mellitus, hyperlipidemia, hyperhomocysteinemia, smoking, or alcohol consumption);
• Reference vessel diameter adjacent to the target lesion ≥ 2 mm；
• Baseline mRS score ≤ 2;
• 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

• Acute ischemic stroke within 2 weeks prior to screening;
• Major surgery or acute myocardial infarction within 30 days prior to screening;
• Intracranial hemorrhage (parenchymal, subarachnoid, subdural, or extradural) within 3 months prior to screening;
• Uncontrolled hypertension despite medical therapy (systolic BP ≥ 180 mmHg or diastolic BP ≥ 110 mmHg);
• Coexisting intracranial tumor, intracranial aneurysm requiring treatment, or arteriovenous malformation;
• Previous stenting of the target lesion or any intracranial stenting/endovascular procedure within the past 3 months;
• Cardioembolic stroke;
• Stroke caused solely by perforator artery occlusion;
• Two or more consecutive lesions with ≥ 70% stenosis in the target vessel;
• Additional de novo or in-stent restenosis lesions (> 70% diameter stenosis);in other intracranial arteries requiring treatment during the same session;
• Severe calcification, extreme angulation, severe tortuosity, or other anatomical features in the target vessel that may prevent safe device delivery or retrieval;
• Known allergy or contraindication to heparin, sirolimus (rapamycin), iodinated contrast, aspirin, clopidogrel, or local anesthetics;
• Gastrointestinal bleeding within 6 months prior to informed consent, rendering antiplatelet therapy unsafe;
• Platelet count < 90 × 10⁹/L;
• INR > 1.5;
• Pregnant, breastfeeding, or planning pregnancy within 1 year;
• Life expectancy < 1 year;
• Participation in another drug or device clinical trial currently or planned during the study period;
• Intracranial stenosis due to non-atherosclerotic etiology (e.g., arterial dissection, moyamoya disease, vasculitis, active arteritis, thrombosis);
• 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);
• Flow-limiting dissection or residual stenosis > 50% after pre-dilatation;
• Any other condition that, in the investigator's judgment, makes the patient unsuitable for enrollment;