A Prospective, Multi-center, Single Arm Study to Obtain "Real World" Clinical Data and Characterize the Acute and Long-term Performance of the MICRUSFRAME and GALAXY Coils Including the PulseRider Aneurysm Neck Reconstruction Device for the Endovascular Treatment of Intracranial Aneurysms
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 723
- 试验地点
- 81
- 主要终点
- Occlusion Rate
研究概览
简要总结
A post-market registry evaluating ruptured/unruptured aneurysms treated with MICRUSFRAME and GALAXY coils
详细描述
A registry to collect real world data on the use of Cerenovus coils. The study will be a post-market registry evaluating ruptured/unruptured aneurysms treated with MICRUSFRAME and GALAXY coils
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is between 21 and 80 years of age
- •Patient has an intracranial saccular aneurysm, ruptured or unruptured, suitable for embolization with coils
- •Patient is able and willing to comply with protocol and follow-up requirements
排除标准
- •Pre-planned staged procedure on unruptured aneurysm
- •More than one aneurysm requiring treatment during the course of study
- •Fusiform aneurysm
研究组 & 干预措施
Coils
MICRUSFRAME and GALAXY coils
干预措施: MICRUSFRAME and GALAXY coils (Device)
结局指标
主要结局
Occlusion Rate
时间窗: 12 Months
Occlusion rate at 12 Months post procedure
Number of Participants Who Achieved Adequate Occlusion (Modified Raymond-Roy I or II Classification) as Assessed by the Independent Core Lab Report of the Target Aneurysm at 1 Year Without Retreatment
时间窗: At 1 year Post Procedure on Day 1
Number of participants who achieved adequate occlusion as assessed by the independent core lab report of the target aneurysm at 1 year without retreatment was reported. Adequate occlusion was defined as the achievement of a Modified Raymond-Roy classification of the aneurysm at 1 year without retreatment. Modified Raymond-Roy Classification scale is a system used to grade the angiographic results of endovascular treatment of brain aneurysms. Class I represents complete obliteration of the aneurysm. Class II indicates residual neck, defined as persistence of a portion of the original arterial wall defect without opacification of the aneurysmal wall. Class III is subdivided into IIIa and IIIb: Class IIIa refers to residual aneurysm filling with contrast opacification within the coil interstices, whereas Class IIIb denotes residual aneurysm filling with contrast outlining the aneurysm wall.
次要结局
- 1. Packing Density(From enrollment to end of treatment at 12 months)
- 2. Complete occlusion rate(12 month)
- 6. Modified Rankin Score(12 Months)
- 7. Length of hospital stay(From enrollment to 12 Months)
- Packing Density Percentage (%) as Assessed by Independent Core Lab(During procedure (Day 1))
- Number of Participants With Complete Occlusion at 1 Year as Assessed by the Independent Core Lab (Modified Raymond-Roy I Classification)(At 1 year Post Procedure on Day 1)
- Recanalization Rate at 1 Year as Assessed by Independent Core Lab(At 1 year Post Procedure on Day 1)
- Number of Participants With Modified Rankin Score (mRS) 0-2 With Unruptured Aneurysms(From baseline (Day 1 of procedure) to 1 year post procedure on Day 1)
- Number of Participants With Retreatment (Surgical or Endovascular)(From baseline (Day 1 of procedure) to 1 year post procedure on Day 1)
- Number of Participants With Device Related Serious Adverse Events (SAEs)(From Day of procedure (Day 1) up to 1 year)
- 1. Packing Density(From enrollment to end of treatment at 12 months)
- 2. Complete occlusion rate(12 month)
- 3. Recanalization Rate(12 Months)
- 4. Device related serious adverse events(12 Months)
- 5. Retreatment Rate(12 Months)
- 6. Modified Rankin Score(12 Months)
- 7. Length of hospital stay(From enrollment to 12 Months)