NCT01101347撤回1 期
A Feasibility Study of the Surpass Aneurysm-Embolization System in Intracranial Arteries
Surpass Medical Ltd.0 个研究点目标入组 10 人开始时间: 2010年4月9日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- 入组人数
- 10
研究概览
简要总结
The purpose of this study is to evaluate safety and performance of the Surpass Aneurysm-Embolization System.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Subject understands the nature of the procedure and provides written informed consent.
- •Subject is willing to return to the investigational site for the thirty day and six month follow-up evaluations.
- •Age 18 years to 80 years.
- •Subject with a non-ruptured saccular, or fusiform intracranial aneurysm arising from a parent vessel with a diameter of > 2mm and < 6mm.
排除标准
- •Pregnancy
- •Enrollment in another trial
- •Allergy or contraindication to aspirin, clopidogrel, heparin, local or general anesthesia
- •History of life threatening allergy to contrast dye.
- •Major surgery within previous 30 days or planned in the next 90 days after enrollment date.
- •Severe neurological deficit that renders the patient incapable of living independently
- •Dementia or psychiatric problem that prevents the patient from completing required follow up
- •Co-morbid conditions that may limit survival to less than one year
- •Subject with anatomy not appropriate for endovascular treatment due to severe intracranial vessel tortuosity or stenosis, or intracranial vasospasm not responsive to medical therapy.
- •Subject with an intracranial mass (tumor (except meningioma), abscess, or other infection), or is undergoing radiation therapy for carcinoma or sarcoma of the head or neck region.
- •Subject has a history of bleeding diathesis or coagulopathy, international normalized ratio (INR) greater than 1.5, or will refuse blood transfusions.
- •Subject has a serum creatinine level greater than 2.0 mg/dL (within 7 days of procedure) which the investigator determines restricts the use of contrast agents.
- •Subject has a previously implanted intracranial stent associated with the symptomatic distribution within the past 12 weeks prior to enrollment date
- •Stenting, angioplasty, or endarterectomy of an extracranial (carotid or vertebral artery) or intracranial artery within 30 days prior to enrollment date
- •Subject has a previously implanted carotid stent associated with the symptomatic distribution within the past 12 weeks prior to enrollment date
- •Subject has uncontrolled atrial fibrillation or known cardiac disorders likely to be associated with cardioembolic symptoms.
- •Subject had a subarachnoid hemorrhage within 12 weeks prior to the enrollment date.
- •Subject with resistance to ASA and/or Clopidogrel.
- •Subject with two or more aneurysms in associated distribution - unless the device is used to treat both aneurysms.
- •Subject has a non-treated arteriovenous malformation (AVM) in the territory of the target aneurysm.
- •Target aneurysm is expected to require more than one device.
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