NCT07542938 Medeliver Intracranial Drug Coated Balloon Catheter for Symptomatic Intracranial Atherosclerotic Stenosis

Eligibility & Interventions

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You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 264 participants in total. It began in 2026-04-15 with a primary completion date of 2026-11-30.

Brief Summary

To evaluate the safety and efficacy of the Medeliver® Intracranial Drug-Coated Balloon Catheter (developed by Beijing Jiu Shi Shen Kang Medical Technology Co., Ltd.) in the endovascular treatment of symptomatic intracranial atherosclerotic stenosis.

Eligibility 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: 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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