NCT05563051进行中（未招募）不适用
Kaneka Endovascular Embolization and Protection
适应症
干预措施
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
- 4
- 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)
研究组 & 干预措施
Interventional treatment
Other
Open label
干预措施: i-ED COIL (Device)
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 (4)
Loading locations...
相似试验
Unknown
不适用
Kanagawa Intravenous and Endvascular Treatment RegistryAcute Ischemic StrokeNCT05213533St. Marianna University Toyoko Hospital4,000
招募中
不适用
Basilar Artery Occlusion Chinese Endovascular Trial in the Extended Time WindowAcute Ischemic StrokeBasilar Artery OcclusionNCT06560203Capital Medical University309
招募中
不适用
Embo Registry; National Registry for Artery EmbolizationOsteoarthritis ShoulderOsteoarthritis, KneeAchilles TendonitisOsteoarthritis ThumbPain, ChronicTendonitis ElbowChronic PainTendonitis ShoulderTenosynovitisNCT06477965Vascular Solutions of North Carolina1,000
招募中
不适用
Endovascular Treatment of Acute Ischemic Stroke With Underlying Intracranial Artery StenosisIntracranial Artery Occlusion With Cerebral InfarctionEndovascular TreatmentsLarge Vessel OcclusionAcute Ischemic StrokeNCT06260969Tianjin Huanhu Hospital470
已完成
不适用
Coil System(Ton-bridgeMT) for Endovascular Embolization of Cranial AneurysmsIntracranial AneurysmsNCT03550638Zhuhai Tonbridge Medical Tech. Co., Ltd.256