NCT01945827撤回不适用
Evaluation of DeltaMaxx® Microcoil System in Intracranial Aneurysms
Codman & Shurtleff0 个研究点开始时间: 2014年1月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 主要终点
- Primary Effectiveness Objective - Angiographic Outcomes
研究概览
简要总结
The primary objective of this registry is to assess the safety and angiographic outcomes of endovascular treatment of intracranial aneurysms using the DeltaMaxx Microcoil System.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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 age ≥18 and ≤80 with a diagnosis of ruptured or unruptured intracranial aneurysm judged suitable for selective endovascular treatment by coil occlusion during single procedure
- •Investigator intends to use DeltaMaxx Microcoil system during coiling procedure
- •Investigator intends to use only Codman Neuro microcoils during coiling procedure
- •Aneurysm size [largest measurement from the cross sectional images to determine overall aneurysm size, not just the lumen] ≥6 mm
- •If ruptured aneurysm: Hunt and Hess 1, 2, or 3
- •If unruptured aneurysm: Subject grade Modified Rankin Scale 0 - 2
- •The subject or his/her Legally Authorized Representative must voluntarily provide Informed Consent for participation in this study and agree to return for all study visits.
排除标准
- •Prior treatment (surgical or endovascular) of the target aneurysm
- •Subjects with more than one aneurysm (>2 mm) that have been treated with endovascular or clipping techniques in the past 30 days.
- •Subject with social, medical or psychological conditions that interfere with treatment and follow-up evaluation
- •Women who are pregnant or plan to become pregnant during the study
- •Life expectancy less than 12 months.
- •Presence of arteriovenous malformation
- •Fusiform, mycotic, traumatic, or tumoral aneurysms
- •Planned aneurysm treatment by parent vessel occlusion
- •Subject enrolled in any concurrent study
结局指标
主要结局
Primary Effectiveness Objective - Angiographic Outcomes
时间窗: 12 Months
The Primary Effectiveness endpoint is the immediate post-procedure and 12-month angiographic occlusion rates assessed by the independent core lab using the modified Raymond-Roy Grading Scale (RRGS) scale
Primary Safety Endpoint - Neurological Morbidity and Mortality
时间窗: 12 months
Neurological Morbidity and Mortality as determined by the NIH Stroke Scale and all-cause mortality, regardless of relationship to the treatment, will be captured over the course of the study
次要结局
- Recurrence Rate(12 months)
- Re-treatment Rate(12 months)
- Packing Density(24 hours)
研究者
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