Prospective Study on Embolization of Intracranial Aneurysms With the Pipeline™ Device (PREMIER)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 197
- 试验地点
- 46
- 主要终点
- The Percentage of Participants With the Occurrence of Major Stroke in the Territory Supplied by the Treated Artery or Neurological Death at 12-Months Post Procedure
研究概览
简要总结
The purpose of this study is to assess the safety and effectiveness of the Pipeline™ device in the treatment of unruptured, wide-neck 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
- 22 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject has provided written informed consent using the IRB/EC-approved consent form and agrees to comply with protocol requirements.
- •Age 22-80 years.
- •Subject has a target intracranial aneurysm (IA) located in the:
- •Internal carotid artery (up to the carotid terminus) OR
- •Vertebral artery segment up to and including the posterior inferior cerebellar artery
- •Subject has a target IA that is ≤ 12 mm.
- •Subject has a target IA that has a parent vessel with diameter 1.5-5.0 mm distal/proximal to the target IA.
- •Subject has a target IA with an aneurysm neck ≥ 4mm or a dome to neck ratio ≤ 1.
- •Subject has a pre-procedure PRU value between 60-200.
排除标准
- •Subject has received an intracranial implant (e.g. coils) in the area of the target IA within the past 12 weeks.
- •Subarachnoid hemorrhage in the past 30 days.
- •Subject with anatomy not appropriate for endovascular treatment due to severe intracranial vessel tortuosity or stenosis determined from baseline or pre-procedure imaging, or a history of intracranial vasospasm not responsive to medical therapy.
- •Major surgery in the last 30 days.
- •History of irreversible bleeding disorder and/or subject presents with signs of active bleeding.
- •Any known contraindication to treatment with the Pipeline™ device, including:
- •Stent is in place in the parent artery at the target IA location
- •Contraindication to dual antiplatelet therapy
- •Relative contraindication to angiography (e.g., serum creatinine >2.5 mg/dL, allergy to contrast that cannot be medically controlled).
- •Known severe allergy to platinum or cobalt/chromium alloys.
- •Evidence of active infection at the time of treatment (e.g., fever with temperature >38°C and/or WBC >1.5 109/L).
- •The Investigator determines that the health of the subject or the validity of the study outcomes (e.g., high risk of neurologic events, worsening of clinical condition in the last 30 days) may be compromised by the subject's enrollment.
- •Pregnant or breast-feeding women or women who wish to become pregnant during the length of study participation.
- •Participating in another clinical trial during the follow-up period that could confound the treatment or outcomes of this investigation.
结局指标
主要结局
The Percentage of Participants With the Occurrence of Major Stroke in the Territory Supplied by the Treated Artery or Neurological Death at 12-Months Post Procedure
时间窗: Up to 12 Months Post Procedure
The primary safety endpoint was defined as a stroke which results in focal neurological deficit for 24 hrs or more and increases the NIH Stroke Scale of the subject by ≥ 4 along with an imaging correlate. Missing data for subjects who failed to complete the 12- month post-procedure evaluation without any evidence of a major stroke in the territory supplied by the treated artery or neurological death were imputed in the analysis using multiple imputation. Multiple imputation provides a mechanism for deriving estimates for a population where not all of the patients have an endpoint determination.
The Percentage of Participants With Complete Aneurysm Occlusion (Defined as Raymond Roy Grade 1) Without Significant Parent Artery Stenosis (≤ 50%) or Retreatment of the Target Aneurysm at 12-Months Post-Procedure
时间窗: Up to 12 Months Post Procedure
The definitions for the three components of the primary effectiveness endpoint were: 1) retreatment, defined as all retreatment procedures occurring between the index procedure and 1 Year post-procedure; 2) complete aneurysm occlusion based on Core Laboratory review of 1-year images and 3) significant parent artery stenosis, based on Core Laboratory review of 1-year images. The Raymond-Roy Grading scale is used for judging intracranial aneurysm (IA) endosaccular embolization success. Grade I is completion occlusion with no flow of contrast seen in the aneurysm sac, Grade II is partial occlusion with some flow or eddy flow in the aneurysm sac and Grade III is residual aneurysm or Incomplete occlusion with apparent flow in the aneurysm sac. Multiple imputation provides a mechanism for deriving estimates for a population where not all of the patients have an endpoint determination.
次要结局
- The Number of Participants Who Experienced Delayed Intracerebral Hemorrhage > 30 Days Post-Procedure(> 30 days, Post Procedure)
- The Number of Participants With a Major Stroke in the Territory Supplied by the Treated Artery or Neurological Death at 30-days Post Procedure Due to Procedural Complications(Up to 30 days, Post Procedure)
- The Number of Participants With Successfully Deployed Investigational Device(Index Procedure)