NCT02309203撤回不适用
Canadian Study of the MicroVention Flow Re-Direction (FRED) Endoluminal Device Stent System in the Treatment of Intracranial Aneurysms - The CanFRED Trial
Centre hospitalier de l'Université de Montréal (CHUM)0 个研究点开始时间: 2014年12月5日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 主要终点
- neurological death or major ipsilateral stroke, measured by mRS.
研究概览
简要总结
The study objective is to evaluate the safety and effectiveness of the MicroVention FRED System when used in the treatment of wide-necked intracranial aneurysms.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject whose age is ≥ 18 years;
- •Subject has a single target aneurysm located in the following zones:
- •Zone 1 - Petrous through cavernous of the ICA
- •Zone 2 - Ophthalmic segment of the ICA
- •Zone 3-Posterior Circulation, basilar artery (not including the basilar bifurcation), vertebral artery
- •Subjects with a single target intracranial aneurysm located along the internal carotid artery, or the vertebral or basilar artery for whom existing endovascular options (coiling, stent-assisted-coiling) could be ineffective or because aneurysm is predisposed to recurrence due to having any of the following characteristics:
- •Aneurysms with a neck > 4mm, dome to neck ratio ≤2 or no discernible neck
- •Fusiform aneurysms of any size requiring treatment;
- •The parent artery must have a diameter of 2.5 - 5.0mm distal/proximal to the target intracranial aneurysm (IA);
- •Subject fulfills study requirements, and the subject or his/her legally authorized representative provides a signed informed consent form;
- •Negative pregnancy test in a female subject who has had menses in the last 24 months;
- •Subject is willing to return for the 1-month and 6-month follow-up evaluations
排除标准
- •Subject who is pregnant or breastfeeding; Subject who suffers from a subarachnoid hemorrhage in the last 60 days;
- •Subject who suffers from any intracranial hemorrhage in the last 30 days;
- •Subject currently undergoing radiation therapy for carcinoma or sarcoma of the head or neck region;
- •Subject with stenosis of the parent artery (>50%) proximal to the target aneurysm;
- •Subject with known platelet dysfunction or a contraindication to or inability to tolerate anticoagulants/antiplatelet agents;
- •Subject with contraindications or severe allergies to anticoagulants or antiplatelet medications (aspirin, heparin, ticlopidine, clopidogrel, prasugrel or ticagrelor);
- •Subject with known hypersensitivity to metal, such as nickel-titanium and metal jewelry
- •Subject with documented contrast allergy, or other condition, that prohibits imaging.
- •Evidence of active bacterial infection at the time of treatment;
- •Subject who has had a previous intracranial stenting procedure associated with the target aneurysm;
- •Subject with life-threatening diseases.
结局指标
主要结局
neurological death or major ipsilateral stroke, measured by mRS.
时间窗: within 6 months post procedure
death or major stroke
时间窗: within 30 days post procedure
A major stroke is defined as a new neurological event that persists for \> 24 hours and results in a mRS \>2. A minor stroke is defined as a new neurological event that persists for \> 24 hours.
次要结局
- Incidence of FRED System and procedure related Serious Adverse Events;(1 year)
- Incidence of successful delivery of the FRED System implant;(24 hours)
- Incidence of migration of the FRED System implant(6 months)
- Unplanned alternative treatment on the target IA (Defined as re-treatment of the target aneurysm due to worsening of the clinical condition of the subject)(Within 6 months)
- Change in clinical and functional outcomes (as measured by an increase in the modified Rankin Scale compared to baseline)(6 months)
研究者
Jean Raymond
MD
Centre hospitalier de l'Université de Montréal (CHUM)
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