NCT02507531终止不适用
INCA: Intracranial Aneurysm Treatment With NeXsys
Cerus Endovascular, Ltd2 个研究点 分布在 1 个国家目标入组 3 人开始时间: 2016年5月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- Safety: occurrence of major ipsilateral stroke or neurologic death
研究概览
简要总结
Prospective, single center first-in-man study of use of device for intracranial aneurysm occlusion
详细描述
Prospective, single center first-in-man study of use of device for intracranial aneurysm occlusion. Target aneurysms are small unruptured aneurysms in the anterior and posterior circulation.
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 18-80 years at screening
- •Unruptured saccular IA in the anterior or posterior circulation with dimensions consistent with Table 2
- •IA appears suitable for NeXsys device
- •Patient willing to comply with study requirements
- •Patient able to understand and sign a study-specific informed consent form
排除标准
- •Ruptured IA
- •Any other IA that requires treatment in the next year
- •IA width >10 mm
- •IA neck >9 mm
- •IA has important flow from its base such that occluding the IA would cause stroke
- •Target IA contains any device (e.g., coils)
- •Inability to access the target IA with microcatheter
- •Any congenital or iatrogenic coagulopathy
- •Platelet count <50,000/microliter
- •Known allergy to platinum, nickel or titanium
- •Known allergy to contrast agents
- •Stenosis of the target IA's parent vessel >50%
- •Taking daily aspirin or other platelet inhibitor (clopidogrel or equivalent)
- •Taking any anticoagulants (e.g., warfarin)
- •Pregnant or planning pregnancy in the next 2 years
- •Other medical conditions that could increase the risk of neurovascular procedures (e.g., liver failure, cancer, etc.)
- •Participating in another study with investigational devices or drugs
研究组 & 干预措施
Treatment
Experimental
Placement of study device (currently called NeXsys) into target aneurysm via standard endovascular procedure.
干预措施: NeXsys Embolization System (Device)
结局指标
主要结局
Safety: occurrence of major ipsilateral stroke or neurologic death
时间窗: 3-6 months
Ability of the investigator to place the device in an acceptable position in the target IA, judged at the time of placement, with no migration or change in position of the device at 3-6 month angiogram.
时间窗: 3-6 mo
次要结局
- Occlusion status of the target IA at 30 days, 3-6 months, 1 year and 5 years as judged by an independent physician using the Raymond classification system.(30 days, 3-6 months, 1 year and 5 years)
- Occurrence rate of any neurologic or vascular adverse event related to the target IA or device placement procedure(Beginning of index procedure to end of index procedure (approximately 1 hour, maximum 3 hours))
研究者
研究点 (2)
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