Not Yet RecruitingNot Applicable

Medeliver Intracranial Drug Coated Balloon Catheter for Symptomatic Intracranial Atherosclerotic Stenosis

264 participantsStarted 2026-04-15

Plain-language 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.

Who can participate

Age range18 Years – 80 Years

SexALL

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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;

What they're measuring

The 12-month post-procedural rates of target lesion restenosis, stroke recurrence or mortality in the territory of the target vessel.

Timeframe: From enrollment to the end of follow-up at 12 months

Trial details

NCT IDNCT07542938

SponsorXuanwu Hospital, Beijing

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-11-30

Contact for this trial

Zhen Li Beijing Highland Med-Tech Development Co.,Ltd

18611537116 jason.lee@hld-cro.com

View on ClinicalTrials.gov More Symptomatic Intracranial Atherosclerotic Stenosis trials