NCT05060185Unknown不适用
A Prospective, Multicenter,Single Arm Clinical Investigation Evaluating Safety and Effectiveness of the Flow Diverter for Treating Patients With Intracranial Aneurysms
Jiangsu CED Medtech Co., Ltd0 个研究点目标入组 166 人开始时间: 2021年10月17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
- 166
- 主要终点
- The rate of complete aneurysm occlusion (Raymond score: Ⅰ) confirmed by 12 postoperative menstrual imaging
研究概览
简要总结
To evaluate the efficacy and safety of the blood flow guide device manufactured by Jiangsu Changyida Medical Technology Co., Ltd. for endovascular embolization of intracranial aneurysms
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •●≥18 years old and ≤75 years old, male or unpregnant female
- •Untreated and unruptured intracranial wide-necked aneurysm confirmed by preoperative imaging diagnosis (wide-necked aneurysm was defined as the tumor neck ≥4mm or the tumor body/tumor neck ratio <2)
- •The target aneurysm is planned to be treated with blood flow guidance device only, without the need to complete the treatment by stages
- •The width of tumor neck should be less than 30mm
- •Imaging measurements of the tumor parent artery showed that the diameter was 1.5mm ~ 6.5mm
- •The subject or legal guardian can understand the purpose of the study, demonstrate sufficient compliance with the study protocol, and sign the informed consent
排除标准
- •The target aneurysm has previously received craniotomy clipping or other endovascular interventional treatment
- •Target aneurysms were haemacular aneurysms, pseudoaneurysms, arteriovenous malformations and moyamoya disease related aneurysms
- •DSA suggested vascular path tortuosity or severe arteriosclerosis, and it was difficult for the instrument to reach the target vessel
- •Contraindications to dual antiplatelet therapy and anticoagulation therapy
- •Patients with known clear allergy to nickel-titanium alloys and platinum-tungsten alloys
- •People with known severe allergy to contrast media (excluding rash)
- •patients with known dementia or mental illness
- •Preoperative complicated with serious heart, liver, kidney, respiratory system diseases and bleeding disorders
- •Life expectancy is less than one year
- •Is participating in, or may participate in, any other drug or medical device clinical trial after inclusion in this clinical trial
- •Other conditions determined by the investigator to be unsuitable for participation in this clinical trial
研究组 & 干预措施
single arm
Other
the patients will be treated by the trial device
干预措施: the Flow Diverter (Device)
结局指标
主要结局
The rate of complete aneurysm occlusion (Raymond score: Ⅰ) confirmed by 12 postoperative menstrual imaging
时间窗: Twelve months after surgery
The cerebral vascular imaging examination 12 months after the operation was performed to analyze whether the aneurysm was completely occluded. Aneurysm occlusion images were reviewed by clinicians and the core laboratory respectively. When the evaluation results were different from those determined by clinicians, the results of the core laboratory should prevail
次要结局
- Immediate postoperative success rate(Immediately after)
- The parent artery was unblocked 12 months after surgery (stenosis rate ≤50%) and no further intervention was performed(Twelve months after surgery)
- The rate of self-care (mRS 0-2 points) at 12 months after operation(Twelve months after surgery)
研究者
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