A Feasibility Study to Evaluate the Safety and Effectiveness of Implantation of 'Flowise Cerebral Flow Diverter' for the Treatment of Unruptured Wide-necked Cerebral Aneurysm in the Internal Carotid Artery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Aneurysm occlusion success at 6month
研究概览
简要总结
The purpose of this study is to evaluate the safety and short-term effectiveness of implantation of 'Flowise Cerebral Flow Diverter' for the treatment of unruptured wide-necked cerebral aneurysm in the internal carotid artery.
详细描述
Flowise is indicated for use in patients with unruptured wide-necked aneurysm in the internal carotid artery. Consecutive subject data should be collected at discharge, 1, 3, and 6 month post Flowise implantation.
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
- 19 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Functional neurological state ≤2 mRS
- •Unruptured wide-neck aneurysm in the internal carotid artery has a size >8mm, a neck ≥4mm, or dome/neck ratio <2
- •Parent artery with diameter ≥3.25mm and ≤4.5mm
- •Patient willing to provide written informed consent and comply with follow-up requirements
排除标准
- •Intracranial hemorrhage within 30 days
- •Untreated ruptured intracranial aneurysm
- •≥1 intracranial aneurysm except the target one requires treatment within 6 months
- •Immunosuppressive disease
- •Active infectious disease (e.g. endocarditis, meningitis)
- •Platelet count < 100 x 103 cells/mm3
- •Female of child-bearing potential who are unable to take adequate contraceptive precautions, are known to be pregnant, or are currently breastfeeding an infant.
研究组 & 干预措施
Flowise Cerebral Flow Diverter
Flowise Cerebral Flow Diverter (TaeWoong Medical Co., Ltd. Korea)
干预措施: Flowise Cerebral Flow Diverter (Device)
结局指标
主要结局
Aneurysm occlusion success at 6month
时间窗: 6months
Aneurysm occlusion success is defined as Raymond class Ⅰ, Ⅱ
Procedural success
时间窗: 5days
Procedural success is defined as the full expansion of the Flowise identified on angiography and the full coverage of the targeted aneurysm neck in the absence of periprocedural stroke or death.
≥50% intracranial aneurysm size reduction success at 6 month
时间窗: 6months
Intracranial aneurysm size is measured by Transfemoral Cerebral Angiography (TFCA).
次要结局
- ≥50% Parent artery stenosis or occlusion(6months)
- Newly developed neurological disorder(6months)
- Ipsilateral stroke(6months)
- 30-day death(6months)
- Other adverse events(6months)