NCT01753388撤回2 期
Safety and Performance of the Penumbra Liberty Stent in the Treatment of Wide-Neck, Saccular, Intracranial Aneurysms
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 4
- 主要终点
- Aneurysmal occlusion of the treated target lesion on 6-month angiography as defined by the method of Roy et al. (Stroke 2001;32:1998-2004).
研究概览
简要总结
The purpose of this study is to assess the safety and performance of the Penumbra Liberty Stent System as adjunctive treatment to embolic coils for wide-neck, saccular, 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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient from 18 to 85 years old
- •A symptomatic unruptured saccular intracranial aneurysm with a neck ≥4mm (or a dome to neck ratio <2) and a parent vessel diameter between 2.5 to 5.0 mm (inclusive) in both the anterior and posterior circulation of the brain, that is amenable to stent-assisted coiling. "Symptomatic" is defined as any neurological symptoms attributed to the target aneurysm.
- •Life expectancy >6 months
- •Signed Informed Consent
排除标准
- •Aneurysm with branches from the aneurysm base
- •Rapidly growing aneurysm
- •Daughter aneurysm
- •Aneurysm with partial or complex calcifications
- •Females who are nursing, pregnant or intend to become pregnant during the study. Females of child-bearing potential must have a urinary pregnancy test within 7 days of enrollment and use an approved highly efficient contraceptive method during the study
- •Multiple untreated cerebral aneurysms at study entry
- •Recent history of stroke, TIA, subarachnoid hemorrhage, intracranial hemorrhage, or major surgery within one month of enrollment
- •Previous brain surgery or irradiation of the target treatment territory that would, in the opinion of the investigator, interfere with the treatment of the target aneurysm
- •Admission platelet <150,000 or any known hemorrhagic diathesis, coagulation deficiency, or on oral anticoagulant therapy
- •Underlying unstable Coronary Artery Disease, cardiac insufficiency or Myocardial Infarction
- •Contraindication to angiography such as elevated creatinine or known allergy to angiographic contrast
- •Contraindication to CT and/or MRI scans
- •Known allergy to the metal component of the Penumbra Liberty Stent System
- •Evidence of active infection (WBC >10x109/L)
- •Any medical conditions that will not allow the necessary follow-up for this study (e.g., pre-existing neurological or psychiatric diseases)
- •Current substance-abuse/illicit drug use
- •Angiographic evidence of an arterial stenosis proximal to the target lesion that could prevent device deployment
- •Contraindications to study medications (heparin, aspirin, clopidogrel, and radiographic contrasts)
- •Patients unable to sign Informed Consent due to the emergency conditions of the intervention
研究组 & 干预措施
Treatment by the Liberty Stent
Experimental
干预措施: Liberty Stent (Device)
结局指标
主要结局
Aneurysmal occlusion of the treated target lesion on 6-month angiography as defined by the method of Roy et al. (Stroke 2001;32:1998-2004).
时间窗: 6 months post-procedure
Procedural device-related serious adverse events
时间窗: During the procedure
次要结局
- All cause mortality(At 6 months post-procedure)
- Device patency and migration(At 6 months post-procedure)
- Retreatment(At 6 months)
- Intracranial hemorrhage(At 6 months post-procedure)
- Functional outcome as defined by the modified Rankin Scale (mRS)(At 6 months post-procedure)
研究者
研究点 (4)
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