Aneurysm Study of Pipeline in an Observational Registry
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 200
- 试验地点
- 59
- 主要终点
- Incidence of Neurological Adverse Events following PED use
研究概览
简要总结
The primary objective of this study is to further expand the body of clinical knowledge in patients undergoing Pipeline Embolization Device (Pipeline or PED) placement for intracranial aneurysms (IAs or ICAs) according to Pipeline's labeled indication.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(All sites, All countries)
- •At least 1 Pipeline placed for treatment of an ICA
- •Patient or patient's Legally Authorized Representative (LAR) has signed an IRB- or EC-approved informed consent form, if required
- •Patient is willing and able to comply with follow-up visits
- •United States: Additional Inclusion Criteria for subjects enrolled in the United States:
- •4US) Subjects who are age 22 or higher 5US) IA of at least 10 mm in maximum dimension along the internal carotid artery between the petrous and superior hypophyseal segments
- •Canada: Additional Inclusion Criteria for subjects enrolled in Canada:
- •4C) In Canada, the Pipeline™ Embolization Device is intended for use with or without embolic coils for the treatment of complex intracranial aneurysms that are not amenable to treatment with surgical clipping.
- •5C) Canadian licensing/approval is limited to devices that are between 3.25 mm and 5.00 mm in diameter.
- •France: Additional Inclusion Criteria for subjects enrolled in France:
- •4F) Unruptured IA, saccular or fusiform with an aneurysm sac diameter > 15mm and not treatable with other current therapies ( EVT with coils with or without assisting system (intracranial stent) or balloon remodeling, or surgery) due to its specific morphology.
- •5F) IA previously treated with unruptured recanalization of the aneurismal sac > 7 mm, not treatable with conservative treatment.
排除标准
- •(based on contraindications PED IFU)
- •Active bacterial infection
- •A patient in whom dual antiplatelet therapy (aspirin and clopidogrel) is contraindicated
- •A patient who has not received dual antiplatelet agents prior to the procedure
- •Pre-existing stent is in place in the parent artery at the target aneurysm location
- •Angiography demonstrates inappropriate anatomy, e.g., severe pre-or post-aneurysm narrowing
- •Acutely ruptured aneurysm, defined as rupture of the target aneurysm Each site should refer to their country specific Instructions for Use/Approval(France) to determine final eligibility into the ASPIRe Registry.
研究组 & 干预措施
Aneurysms treated with Pipleline
Aneurysms treated with Pipleline. All patients independently treated according to the labeled indications for use with the Pipeline Embolization Device
干预措施: Pipeline Embolization Device (Device)
结局指标
主要结局
Incidence of Neurological Adverse Events following PED use
时间窗: From Device placement until last follow up, for an average of 3 years of follow up for each subject enrolled
The primary endpoint will consist of a composite of any/all of the events listed below. * Incidence of spontaneous rupture of Pipeline treated aneurysm * Incidence of other (non-aneurysmal) intracranial hemorrhage, ipsilateral and contralateral * Incidence of ischemic stroke * Incidence of symptomatic and asymptomatic parent artery stenosis * Incidence of permanent cranial neuropathy * Incidence of change in baseline neurologic signs/symptoms related to Pipeline treated ICA(s) at last assessment
次要结局
未报告次要终点