Pipeline for Uncoilable or Failed Aneurysms
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 108
- 试验地点
- 11
- 主要终点
- Number of Participants With the Occurrence of Major Ipsilateral Stroke or Neurologic Death and Occurrence of Ipsilateral Stroke or Neurologic Death.
研究概览
简要总结
To determine the safety and effectiveness of Pipeline Embolization Device for the treatment of uncoilable or failed wide-necked intracranial aneurysms (IA).
详细描述
Patients with large or giant aneurysms of the internal carotid artery treated with PED. Angiographic follow-up occurs at 3 and 5 years.
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
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 21 to 75 years, inclusive
- •Patient has a single target IA in the anterior or posterior circulation that:
- •a) Is located in the following regions of the internal carotid artery: i. Paraophthalmic (including paraclinoid, ophthalmic and hypophyseal segments) ii. Cavernous iii. Petrous
- •b) Has a neck >4 mm or no discernible neck AND a size (maximum fundus diameter) >10 mm
- •c) Has a parent vessel with diameter 2.5 - 5.0 mm distal/proximal to the target IA
- •Subject has provided written informed consent using the Institutional Review Board (IRB)-approved consent form
- •Subject has the necessary mental capacity to participate and is willing and able to comply with protocol requirements
排除标准
- •More than one IA requires treatment in the next 6 months
- •Subarachnoid hemorrhage from target IA in the past 60 days
- •Unstable neurologic deficit (i.e., any worsening of clinical condition in the last 30 days)
- •Irreversible bleeding disorder
- •Platelet count < 100 x 103 cells/mm3 or known platelet dysfunction
- •Inability to tolerate, documented evidence of adverse reaction or contraindication to study medications
- •Stent in place at the target IA
- •Contraindication to CT scan or MRI
- •Allergy to contrast used in angiography that cannot be medically controlled
- •Known severe allergy to platinum or cobalt/chromium alloys
- •Relative contraindication to angiography (e.g., serum creatinine > 2.5 mg/dL)
- •Woman of child-bearing potential who cannot provide a negative pregnancy test
- •Evidence of active infection at the time of treatment
- •Other conditions of the heart, blood, brain or intracranial vessels that carry a high risk of neurologic events (e.g., severe heart failure, atrial fibrillation, known carotid stenosis)
- •Any comorbid disease or condition expected to compromise survival or ability to complete follow-up assessments to 180 days
- •Extracranial stenosis greater than 50% in the carotid artery for anterior circulation aneurysms
- •Intracranial stenosis greater than 50% in the treated vessel
研究组 & 干预措施
Pipeline
Placement of Pipeline Embolization Device in the parent artery at the aneurysm location
干预措施: Pipeline Embolization Device (PED) (Device)
结局指标
主要结局
Number of Participants With the Occurrence of Major Ipsilateral Stroke or Neurologic Death and Occurrence of Ipsilateral Stroke or Neurologic Death.
时间窗: 180-days and 5-years
The number of participants with occurrence of major ipsilateral stroke or neurologic death after PED placement at 180-days and the occurrence of ipsilateral stroke or neurologic death after Pipeline Embolization Devices (PED) placement at 5-years.
Count of Intracranial Aneurysms (IA) Evaluated as Completely Occluded (100%) Without Major Parent Artery Stenosis.
时间窗: 180 days
The count of Intracranial Aneurysms (IA) evaluated as completely occluded (defined as Raymond Grade 1) without major parent artery stenosis at 180 days. The Raymond-Roy Grade scale measures the amount of visual contrast flow throughout the aneurysm anatomy. The Raymond-Roy aneurysm occlusion scale is follows: Complete = complete occlusion, no flow of contrast seen in the sac Residual Neck = partial occlusion, some flow, or eddying flow, in the sac Residual Aneurysm = incomplete occlusion, apparent flow into the sac
次要结局
- Count of Intracranial Aneurysms (IA) Evaluated as Completely Occluded (100%) at 1 Year(1 Year)
- Count of Intracranial Aneurysms (IA) Evaluated as Completely Occluded (100%) at 3 Year Follow-up(3 years)
- Count of Intracranial Aneurysms (IA) Evaluated as Completely Occluded (100%) at 5 Years(5 years)
- Stenosis of the Parent Artery in PED at 3 Years(3-years)
- Stenosis of the Parent Artery in PED at 5 Years(5-years)
- Number of Participants With Device-Related Adverse Events at 3 Years(3 years)
- Number of Participants With Device-related Adverse Events at 5 Years(5 years)