A Prospective, Multi-center, Single Arm Study to Evaluate the Safety and Effectiveness of the PulseRider® Aneurysm Neck Reconstruction Device Used in Conjunction With Endovascular Coil Embolization in the Treatment of Wide-Neck Bifurcation Intracranial Aneurysm
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 21
- 试验地点
- 3
- 主要终点
- Number of Participants With Complete Aneurysm Occlusion Without Significant Parent Artery Stenosis or Prior Retreatment Through 1 Year Post-Procedure
研究概览
简要总结
This is a prospective, multi-center, non-randomized clinical evaluation utilizing the PulseRider® Aneurysm Neck Reconstruction Device.
详细描述
The objective of this study is to evaluate the safety and effectiveness of the PulseRider® Aneurysm Neck Reconstruction Device in conjunction with coil embolization in the endovascular treatment of unruptured wide-neck intracranial aneurysms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject with wide neck intracranial aneurysm located at a bifurcation
- •The subject is between 18 and 80 years of age the time of consent
- •Informed consent is obtained and the subject signs the IRB approved consent prior to beginning any study procedures
- •In the opinion of the treating physician, placement of the PulseRider® device is technically feasible and clinically indicated
排除标准
- •Unstable neurological deficit (condition worsening within the last 90 days)
- •Subarachnoid Hemorrhage (SAH) within the last 60 days
- •Irreversible bleeding disorder
- •Patient has another intracranial aneurysm that in the Investigator's opinion, may require treatment within the 1 year follow up period
- •A history of contrast allergy that cannot be medically controlled
- •Known allergy to nickel
- •Relative contraindication to angiography
- •Woman of child-bearing potential who cannot provide a negative pregnancy test
- •Current involvement in a study for another investigational product
- •Patient and / or family considering a move from this geographical location at the time of consent
- •Categorized as a vulnerable population and require special treatment with respect to safeguards of well-being (e.g. cognitively impaired, veteran, prisoner, etc.)
结局指标
主要结局
Number of Participants With Complete Aneurysm Occlusion Without Significant Parent Artery Stenosis or Prior Retreatment Through 1 Year Post-Procedure
时间窗: Up to 1 year post procedure
Number of participants with complete aneurysm occlusion (Raymond I: complete occlusion) without significant parent artery stenosis (greater than \[\>\] 50 percent \[%\] stenosis) or prior retreatment through 1-year post procedure were reported.
Percentage of Participants With Occurrence of Neurological Death or Major Ipsilateral Stroke in Downstream Territory up to 1 Year Post-procedure Per Clinical Events Committee (CEC)
时间窗: Up to 1 year post procedure
Percentage of participants with occurrence of neurological death or major ipsilateral stroke in downstream territory up to 1 year post-procedure per CEC were reported. Major stroke is defined as stroke with symptoms persisting for more than 24 hours and a sudden increase in the National Institutes of Health Stroke Scale (NIHSS) of the subject by greater than or equal to (\>=) 4. Major ipsilateral stroke is major stroke in downstream territory.
次要结局
- Number of Participants With Target Aneurysms Retreatment(Up to 1 year)
- Number of Participants With Adequate Aneurysm Occlusion(1 year)
- Number of Participants With Modified Rankin Scale (mRS) 0-2(1 year)
- Number of Participants With Technical Success of Successful Implantation of the PulseRider Device(Up to 1 year)
- Number of Participants With Significant Stenosis (>50%) at Implant Site(Up to 1 year)