NCT04949880进行中（未招募）不适用
The Efficacy and Safety Study for Endovascular Treatment of Symptomatic Intracranial Atherosclerotic Stenosis Using Neurovascular Drug-Eluting Balloon Dilatation Catheter: A Prospective Multicentre Single-arm Trial
Zhejiang Zylox Medical Device Co., Ltd.11 个研究点 分布在 1 个国家目标入组 132 人开始时间: 2021年11月2日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 132
- 试验地点
- 11
- 主要终点
- Restenosis rate of the target lesion
研究概览
简要总结
This is a trial designed to test the efficacy and safety of the Neurovascular Drug-Eluting Balloon Dilatation Catheter.
详细描述
This is a prospective multicentre single-arm trial conducted by 11 centers in mainland China. Approximately 132 subjects with symptomatic intracranial atherosclerotic stenosis receive endovascular treatment using the neurovascular drug-eluting balloon dilatation catheter designed by Zylox.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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 to 80 years, any gender;
- •Subject has symptomatic intracranial atherosclerotic stenosis that the degree of the artery stenosis is between 70% and 99% diagnosed by intracranial angiography;
- •The target stenotic artery locates in Internal Carotid Artery (intracranial segment), Middle Cerebral Artery (M1, M2), Basilar Artery, Vertebral Artery (intracranial segment);
- •Intracranial artery stenosis requiring interventional treatment is a single lesion;
- •Subject has at least two atherosclerosis risk factors including history or present hypertension, diabetes, hyperlipidemia, smoking, age>45;
- •modified Rankin Scale(mRS) score≤2 before enrollment;
- •Subject or guardian is able to understand the purpose of study, agree to provide follow-up data and has provided written informed consent.
排除标准
- •History of acute ischemic stroke within 2 weeks;
- •History of intracranial hemorrhage (including intraparenchymal hemorrhage, subarachnoid hemorrhage, subdural hemorrhage and epidural hemorrhage) within 3 months;
- •Hypertension uncontrolled by medicine (Systolic pressure≥180 mmHg or diastolic pressure≥110 mmHg continuously);
- •Combined with the intracranial tumor, aneurysm or intracranial arteriovenous malformation;
- •The length of intracranial artery stenosis >10mm and extremely angulated >90°, which indicated by angiography;
- •History of stent intervention within the target lesion;
- •Allergic to heparin, sirolimus (i.e. rapamycin), contrast agents, aspirin, clopidogrel, anesthetics;
- •History of gastrointestinal hemorrhage within 6 months before signing the informed consent form, which is unable to receive antiplatelet therapy;
- •Platelet (PLT)<90*10^9/L;
- •Creatinine>250 umol/L;
- •International Normalized Ratio (INR)>1.5;
- •Female subject who is pregnant or breast-feeding, or who has a pregnancy plan within 12 months;
- •Expected life <12 months;
- •Unable to cooperate with or tolerate the interventional surgery;
- •Subject who has participated in other drug or device clinical trials or hasn't reached the primary end point;
- •Angiography indicates intracranial artery stenosis caused by arterial dissection, arteritis, and thrombosis;
- •Angiography indicates the vascular path is tortuous, the experimental device is difficult to reach the target position or be retracted;
- •Other circumstances judged by researchers that are not suitable for enrollment.
结局指标
主要结局
Restenosis rate of the target lesion
时间窗: 180+60 days
Subjects receive Digital Subtraction Angiography (DSA) / Computed Tomography Angiography (CTA) examination in 180 days to analyze whether the degree of stenosis is greater than or equal to 50%, if so, the target lesion restenosis happens.
次要结局
- Success rate of surgery(Intraoperation)
- Average stenosis degree of the target lesion(180+60 days)
- Success rate of device(Intraoperation)
研究者
研究点 (11)
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