NCT02415010终止不适用
A Post-Market Clinical Follow-Up Study to Confirm Clinical Performance and Safety of the Codman Enterprise® 2 Vascular Reconstruction Device in the Endovascular Treatment of Intracranial Aneurysms
Cerenovus, Part of DePuy Synthes Products, Inc.10 个研究点 分布在 4 个国家目标入组 26 人开始时间: 2015年7月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 26
- 试验地点
- 10
- 主要终点
- Incidence of Major Ipsilateral Stroke and/or Death due to related neurological event in subjects with a non-ruptured aneurysm.
研究概览
简要总结
The objective of this Post-Market Clinical Follow-up (PMCF) is to confirm the performance and safety of the Codman Enterprise® 2 when used in conjunction with endovascular coil embolization of ruptured or non-ruptured intracranial aneurysms.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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 ≥ 18 years old.
- •Subjects with non-ruptured or ruptured intracranial aneurysm that is referred for endovascular treatment.
- •Parent vessel with a diameter of ≥ 2.0 mm and ≤ 4 mm.
- •Subject understands the nature of the procedure and provides voluntary written informed consent in accordance with the requirements of this study protocol.
- •Subject is willing to participate in the telephone follow-ups and to return to the investigational site for the post-procedure follow-up evaluations.
排除标准
- •Angiogram demonstrating that the aneurysm is not appropriate for endovascular treatment (i.e.: severe intracranial vessel tortuosity, stenosis, intracranial vasospasm not responsive to medical therapy).
- •Mycotic or traumatic aneurysm.
- •Arteriovenous malformation (AVM) in the territory of the target aneurysm.
- •Two or more aneurysms (>2mm) in associated distribution.
- •Hunt and Hess Scale (HHS) of IV or V at inclusion for subject with ruptured aneurysms.
- •Life expectancy of less than 6 months as determined by the treating physician.
- •A planned staged procedure (i.e. a procedure where entire treatment with the devices (e.g. coils/stents) is completed over separate sessions).
- •Previous neuro-interventional or neuro-surgical procedure of any kind within 30 days prior to the study procedure.
- •Intracranial mass (tumor, abscess, or other infection), or undergoing radiation therapy for carcinoma or sarcoma of the head or neck region.
- •Unsuitable for the antithrombotic and/or anticoagulant therapies
- •Serum creatinine level > 2.5 mg/dl within 7 days prior to index procedure
- •Known hypersensitivity or allergies to cobalt, nitinol metal, nickel, or sensitivity to contrast media,
- •Evidence of an acute myocardial infarction (MI) within 30 days prior to the index procedure.
- •Uncontrolled atrial fibrillation or known cardiac disorders likely to be associated with cardioembolic symptoms.
- •Subject is pregnant
结局指标
主要结局
Incidence of Major Ipsilateral Stroke and/or Death due to related neurological event in subjects with a non-ruptured aneurysm.
时间窗: 6 months
any a new neurological event, which is ipsilateral and in the vascular distribution territory of the stenting procedure and that results in an increase of ≥ 4 on the National Institute of Health Stroke Scale (NIHSS), as compared to baseline and persists for greater than 24 hours
次要结局
- Incidence of Successful Aneurysm treatment(12 months)
- Incidence of Parent Vessel Thrombosis(6 & 12 Months)
- Incidence of Successful Aneurysm treatment without retreatment(6 Months)
- Incidence of Retreatment(6 & 12 Months)
- Incidence of New Neurological Deficits(30 Days, 6 & 12 Months)
- Incidence of Major Ipsilateral Stroke and/or Death due to related neurological event(30 Days and 12 Months)
- Incidence of Parent Vessel Stenosis(6 & 12 Months)
- Incidence of Aneurysm Recanalization(6 & 12 Months)
- Incidence of Stent Movement/Migration(6 & 12 Months)
- Frequency of Adverse Events(6 & 12 Months)
研究者
研究点 (10)
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