Medeliver Intracranial Drug-Coated Balloon for symptomatic intracranial stenosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study aims to assess the safety and potential effectiveness of the Medeliver intracranial drug-coated balloon catheter during endovascular treatment of symptomatic intracranial atherosclerotic stenosis. Eligible participants are adults 18 to 80 with 70–99% intracranial stenosis who have had symptoms within the past six months and meet specific anatomic and health criteria. The procedure may include the Medeliver drug-coated balloon or a standard intracranial balloon dilatation catheter as part of the intervention. Key exclusions include recent acute ischemic stroke or recent major surgery or myocardial infarction. The trial is led by Xuanwu Hospital with multiple participating centers in China to evaluate safety and preliminary efficacy and to inform future use in this condition.

Why it matters

Who can join: the full rules

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;

Where it's running

• 首都医科大学宣武医院
  Beijing, Beijing Municipality, China Recruiting
• 福建医科大学附属协和医院
  Fuzhou, Fujian, China Recruiting
• 河北省人民医院
  Shijiazhuang, Hebei, China Recruiting
• 哈尔滨医科大学附属第一医院
  Harbin, Heilongjiang, China Recruiting
• 南阳市中心医院
  Nanyang, Henan, China Recruiting
• 河南省人民医院（包含总院及北院区）
  Zhengzhou, Henan, China Recruiting

Study contacts

• Study coordinator: Zhen Li Beijing Highland Med-Tech Development Co.,Ltd
• Email: jason.lee@hld-cro.com
• Phone: 18611537116

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.