NCT05563051进行中（未招募）不适用
Kaneka Endovascular Embolization and Protection
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 164
- 试验地点
- 8
- 主要终点
- Adequate Occlusion
研究概览
简要总结
Prospective, multi-center, non-randomized registry / study, up to 164 patients enrolled and followed at 180 days +/- 45 days and again at 365 days +/- 90 days post procedure
详细描述
Assess and describe real world clinical data on i-ED coils Characterize the acute and long-term performance of iED coils when used for treating for an intracranial aneurysm May be used alone or in combination with other adjunctive device(s)
Study Duration
Anticipated timeline for study:
Patient enrollment in 18 - 24 months Completion of follow-up 12 months after last patient enrolled
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Target aneurysm of 4mm - 14mm in size
- •Ruptured or unruptured
- •Suitable for embolization with coils
- •May be treated with or without assist devices
排除标准
- •Unstable neurological deficit in unruptured cases (condition worsening within last 90 days)
- •Pre-planned staged procedure of target aneurysm
- •mRS score 3 or more
- •Hunt Hess Score more than 3 for subjects with ruptured aneurysm
- •Evidence of active infection (e.g.,fever, temperature >38 degrees C and/or WBC >15,000)
结局指标
主要结局
Adequate Occlusion
时间窗: 12 months
Proportion of subjects who achieve Adequate Occlusion (Modified Raymond-Roy I or II Classification)
次要结局
- Complete Occlusion(12 months)
- Adverse events(12 months)
- Packing Density(12 months)
- Modified Rankin Score(12 months)
- Retreatment(12 months)
研究者
研究点 (8)
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