The Penumbra Liberty Trial: Safety and Effectiveness in the Treatment of Wide-Neck Intracranial Aneurysms
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 6
- 主要终点
- Number of Neurological Deaths or Major Ipsilateral Strokes at 12 Months Post Treatment.
研究概览
简要总结
To assess the safety and effectiveness of the Penumbra Liberty Stent System as adjunctive treatment to embolic coils for wide-neck, saccular, intracranial aneurysms in the internal carotid artery (ICA). The Liberty Stent System is an implantable device comprised of a stent and delivery system designed as an adjunct to embolic coils in the treatment of wide-neck, saccular, intracranial aneurysms. It has three components: an implant, an introducer sheath and a delivery wire assembly. The implant component is made of superelastic and biocompatible nitinol tubular material. Patients presenting with wide-neck, saccular, intracranial aneurysms in the internal carotid artery (ICA) from the cavernous segment to the carotid terminus (including the paraclinoid, ophthalmic, hypophyseal and posterior communicating segments) will receive stent assisted coiling by the Penumbra Liberty Stent with any approved embolic coils currently on the market. Wide-neck aneurysms are defined by a neck ≥4mm or a dome-to-neck ratio <2. Each patient will be followed and assessed for 2, 6 and 12 months after enrollment.
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
- •At least 18 years old
- •A wide-neck intracranial saccular aneurysm with a neck ≥ 4mm or a dome to neck ratio <2 in the ICA from the cavernous segment to the carotid terminus (including the paraclinoid, ophthalmic, hypophyseal and posterior communicating segments)
- •Life expectancy > 12 months
- •Signed Informed Consent
排除标准
- •Females who are 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)
- •Extradural aneurysms
- •Known multiple untreated cerebral aneurysms at study entry
- •Recent history of subarachnoid hemorrhage, intracranial hemorrhage, or major surgery within one month of enrollment
- •Admission platelet <50,000 or any known hemorrhagic diathesis, coagulation deficiency, or on oral anticoagulant therapy with an INR >3.0
- •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)
研究组 & 干预措施
Liberty Stent arm
Patients are implanted with the Liberty Stent as an assist to embolic coiling of their wide-neck, saccular, intracranial aneurysms and follow for 12 months
干预措施: Stent assisted coiling with the Liberty Stent (Device)
结局指标
主要结局
Number of Neurological Deaths or Major Ipsilateral Strokes at 12 Months Post Treatment.
时间窗: At 12 months post-implant
Number of Participants With Raymond Class I Complete Obliteration at 12 Months
时间窗: At 12 months post-implant
Complete aneurysmal obliteration is defined by the method of Raymond et al. (Class I) (Stroke 2001;32:1998-2004).
次要结局
- Number of Ipsilateral Ischemic Strokes(At 12 months post-implant)
- Number of Participants With Device-related Serious Adverse Events(During the procedure)
- Number of Participants With Aneurysm Raymond Class I Occlusion Grading(At 12 months post-implant)
- Number of Intracranial Hemorrhages(At 12 months post-implant)
- Number of Device Deployment Failures(During the procedure)
- Number of Participants With Functional Outcome as Defined by the Modified Rankin Scale (mRS) 0-2(At 12 months post-implant)
- Number of Participants Who Experienced Device Patency(at 12 months post-implant)
- Number of Device Migrations(12 months post-implant)
- All Cause Mortality (Number of Deaths From Any Cause)(At 12 months post-implant)
- Number of Retreatments(At 12 months post-implant)
- Number of Participants Who Experienced Aneurysm Recanalization(At 12 months post-implant)