NCT05275296Unknown不适用
Prospective, Multi-center, Open-label, Non-inferiority, Randomized, Cotrolled Registration Trial of the Intracranial Visualized Stent for the Wide-necked Intracranial Aneurysms
MicroPort NeuroTech Co., Ltd.1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2022年1月24日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Adequate occlusion rate of aneurysms
研究概览
简要总结
A registration trial of the Intracranial Visualized stent in the treatment of wide-necked intracranial aneurysms
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
- 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
- •At the time of signing the informed consent form(ICF), the applicant shall be male or non-pregnant female, aged 18 to 80 years;
- •Target aneurysms was diagnosed as intracranial wide-necked saccular aneurysms(neck ≥4mm, or body-neck ratio <2) by DSA/CTA/MRA；
- •The diameter of the parent vessel should be 2.0 to 4.5mm;
- •The target aneurysm should be suitable for stent-assisted coiling surgery and could be treated through one operation;
- •Subject or its legal representative should be able to understand the purpose of this study, also agree to comply with protocol and sign the informed consent form voluntarily.
排除标准
- •Subject whose mRS score was greater or equal to 3 during the clinical evaluation before enrollment;
- •Subject with recurrent aneurysm which was already embolized through stent-assisted coiling surgery;
- •Subject with multiple aneurysms that cannot be treated by single stent;
- •Subject with aneurysm ruptured within 30 days;
- •Subject who is not suitable for anesthesia or endovascular surgery;
- •Subject with significant stenosis of the parent arterty(>50%)
- •Subject who underwent major sugical procedure (such as internal fixation for limb fractures, tumor resection, surgery for vital organs, etc.) within 30 days before signing the ICF or would underwent major sugical procedure 60 days after signing the ICF;
- •Subject who is currently participating in a clinical trial of another drug or device which has not met the primary endpoint, or who are expexted to participate in a clinical trial of another durg or device;
- •Subject with conditions or pathological changes which may interfere with the use of instrument, including but not limited to: carotid artery dissection, vasculitis, aortic dissection, etc;
- •Subject who is contraindicated with stent-assisted coiling:
- •Subject with allergy to required anti-platelet and/or heparin medications required for treatment; Subject with allergy to radiographic contrast; Subject with allergy to Nitinol, platinum-tungsten, platinum-iridium alloy.
- •Women who is pregnant or now breastfeeding;
- •Subject with a life expectancy less than 12 months.
研究组 & 干预措施
experimental group
Experimental
Microport NeuroTech Intracranial Visualized Stent
干预措施: Intracranial stent for wide-necked aneurysms (Device)
control group
Active Comparator
LVIS™ and LVIS™ Jr
干预措施: Intracranial stent for wide-necked aneurysms (Device)
结局指标
主要结局
Adequate occlusion rate of aneurysms
时间窗: Time Frame: 360±60 days
The Raymond-Roy intracranial aneurysm occlusion classification was used to assess the rate of aneurysm occlusion postoperatively or at the time of primary endpoint assessment (12 months). Occlusion rates were reported as Class I: complete occlusion; Class II: residual neck; Class III: residual aneurysm. Adequate occlusion rate includes Class I and Class II.
次要结局
- Successful stent placement(Intraoperation)
- Incidence of ipsilateral stroke of neurological death(Time Frame: 360±30 days)
- Incidence of device-related severe adverse event(Time Frame: 360±30 days)
- Retreatment rate(Time Frame: 360±30 days)
- Incidence of device-relared stroke or death(perioperative)
- Incidence od in-stent stenosis (≥50%)(Time Frame: 360±30 days)
- Complete occlusion rate of aneurysms(Time Frame: 360±30 days)
- Incidence of aneurysm rupture(Time Frame: 360±30 days)
研究者
研究点 (1)
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