A Feasibility Study of the Surpass Aneurysm-Embolization System in Intracranial Arteries
2010年11月26日 更新者:Surpass Medical Ltd.
The purpose of this study is to evaluate safety and performance of the Surpass Aneurysm-Embolization System.
研究概览
研究类型
介入性
注册 (预期的)
10
阶段
- 阶段1
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 80年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:非随机化
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:Aneurysm-Embolization System
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员:Vipul Gupta, MD、Medanta, Medcity
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究注册日期
首次提交
2010年4月8日
首先提交符合 QC 标准的
2010年4月8日
首次发布 (估计)
2010年4月9日
研究记录更新
最后更新发布 (估计)
2010年11月30日
上次提交的符合 QC 标准的更新
2010年11月26日
最后验证
2010年11月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
Aneurysm-Embolization System的临床试验
-
SpineSave AG招聘中脊椎关节炎 | 腰椎不稳 | 退行性脊椎滑脱 | 退行性腰椎管狭窄症 | 椎间盘病 | 小关节关节病瑞士
-
Archus Orthopedics, Inc.未知腰背疼痛 | 脊柱疾病 | 腰椎管狭窄症 | 椎管狭窄 | 腰椎滑脱 | 腿痛
-
Hadassah Medical Organization未知