Pilot Study of the Contour Neurovascular SystemTM
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 20
- 主要终点
- Percentage of Subjects With Major Ipsilateral Stroke/SAH or Death Due to Neurologic Cause Within Six (6) Months After Treatment.
研究概览
简要总结
Prospective, single arm, multi centre study to evaluate the safety and performance of the Contour Neurovascular SystemTM in the treatment of intracranial aneurysm (IA)
详细描述
Prospective, single-arm, multi-centre European study to evaluate the safety and performance of the Contour Neurovascular SystemTM in the treatment of intracranial aneurysm (IA). Target aneurysms are unruptured aneurysms requiring endovascular treatment in the anterior and posterior cerebral 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 Contour Neurovascular SystemTM device Patient has the necessary mental capacity to participate and is willing and able to participate in the study for the duration of the study follow-up and is able 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 >8.5 or <2 mm
- •IA neck >8 or <2 mm
- •IA minimum height <4mm
- •IA embolisation would most likely cause stroke
- •Target IA contains other devices/implants (e.g., coils)
- •Inability to access the target IA with the 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) other than for the target aneurysm
- •Taking any anticoagulants (e.g., warfarin)
- •Abnormal clotting parameters
- •Pregnant, breastfeeding 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.) or ability to comply with study requirements Participating in another study with investigational devices or drugs
结局指标
主要结局
Percentage of Subjects With Major Ipsilateral Stroke/SAH or Death Due to Neurologic Cause Within Six (6) Months After Treatment.
时间窗: 6 months
Percentage of subjects with major ipsilateral stroke/SAH or death due to neurologic cause within six (6) months after treatment. All neurological events were adjudicated by an independent Medical Monitor.
次要结局
- Occlusion Status of the Target IA(6 months (3 patients), 1 year (14 patients), 2 year (2 patients))