NCT07542938招募中不适用
Safety and Efficacy of Medeliver Intracranial Drug Coated Balloon Catheter for Symptomatic Intracranial Atherosclerotic Stenosis(Prospective, Multicenter, Randomized Controlled, Superiority Trial)
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 264
- 试验地点
- 15
- 主要终点
- The 12-month post-procedural rates of target lesion restenosis, stroke recurrence or mortality in the territory of the target vessel.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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;
研究组 & 干预措施
Control Group
Active Comparator
Intervention: Diveroad® Intracranial Balloon Dilatation Catheter Manufacturer: Beijing JSSK Neuro Medical Co., Ltd.
干预措施: Intracranial Balloon Dilatation Catheter (Diveroad®) (Device)
Test group
Experimental
Intervention: Medeliver® Intracranial Drug-Coated Balloon Catheter Manufacturer: Beijing JSSK Neuro Medical Co., Ltd.
干预措施: Intracranial Drug-Coated Balloon Catheter (Medeliver®) (Device)
结局指标
主要结局
The 12-month post-procedural rates of target lesion restenosis, stroke recurrence or mortality in the territory of the target vessel.
时间窗: From enrollment to the end of follow-up at 12 months
次要结局
未报告次要终点
研究者
Fei Chen
Associate Chief Physician
Xuanwu Hospital, Beijing
研究点 (15)
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