NCT03642821已完成不适用
Intracranial Aneurysms Treatment With the OPTIMA Coil System
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 20
- 主要终点
- Morbi-mortality at 30 days
研究概览
简要总结
International, non-randomized, European , multicenter, observational study to collect data for the treatment of intracranial aneurysms with OPTIMA coils system to further document its safety and efficacy
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with small or large intracranial aneurysm, ruptured or unruptured, intended to be selectively treated with the OPTIMA coil system. Patients with recanalized aneurysms previously treated with coils exclusively are also eligible. Balloon and stent assisted coiling are allowed at index procedure.
- •In case of multiple aneurysms, patient can be included when only 1 aneurysm is treated during the procedure and none of the other aneurysms are treated up to 30 days post-procedure
- •Patient older than 18 years
- •Patient who has been informed of the study and has signed an informed consent form where applicable according to local regulations.
排除标准
- 未提供
结局指标
主要结局
Morbi-mortality at 30 days
时间窗: 30 days
Rate of adverse events including thromboembolic events, the bleeding/rebleeding episodes, the rate of retreated aneurysm and the rate of mortality occurring during the procedure and up to 30 days.
Clinical outcomes (mRS) at 30 days
时间窗: 30 days
Classification of the patient clinical and neurological outcomes based on modified Rankin Scale from 0 (no symptoms a all) to 6 (dead). Global outcomes of mRS 0-2 are considered good and those of mRS 3-6 (including mRS 6 - deceased) are considered to be poor.
次要结局
- Morbi-mortality at 12 months(12 months)
- Clinical outcomes (mRS) at 12 months(12 months)
- Aneurysm occlusion rate(Up to 24h and 12 months)
研究者
研究点 (20)
Loading locations...
相似试验
招募中
不适用
A Retrospective, Multicenter, Controlled Clinical Trail: to Evaluate the Efficiency and Safety of Intracranial Aneurysm Assistive Software in the Preoperative AssessmentIntracranial AneurysmNCT05651425Beijing Tiantan Hospital600
已完成
不适用
A Retrospective, Multicenter, Controlled Clinical Trail: to Evaluate the Clinical Efficiency of Intracranial Aneurysm Assistive Software in the Morphological MeasurementIntracranial AneurysmNCT05804474Beijing Tiantan Hospital1,500
进行中（未招募）
不适用
The Helsinki Unruptured Intracranial Aneurysm Quality of Care StudyIntracranial AneurysmNCT06147102Helsinki University Central Hospital173
Unknown
不适用
Efficacy Trial of Intracranial Aneurysm Treatment Using Two Different Endovascular TechniquesIntracranial AneurysmsNCT01084681Balt International160
已完成
早期 1 期
Endovascular Recanalization and Standard Medical Management for Symptomatic Nonacute Intracranial Artery Occlusion TrialIntracranial Artery Occlusion With InfarctionNCT04864691Feng Gao453