NCT01323439已完成不适用
Axium™ MicroFX™ for Endovascular Repair of IntraCranial Aneurysm-A Multicenter Study
Medtronic Neurovascular Clinical Affairs1 个研究点 分布在 1 个国家目标入组 99 人开始时间: 2010年4月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 99
- 试验地点
- 1
- 主要终点
- Anatomic occlusion of the aneurysm
研究概览
简要总结
This is a multicenter, prospective single-arm trial evaluating the safety and efficacy of the Axium MicroFX coil system in 100 aneurysms.
详细描述
This is a multicenter, prospective single-arm trial evaluating the safety and efficacy of the Axium MicroFX coil system in 99 patients at 13 study centers. The primary endpoint of the trial was the anatomic occlusion of the aneurysm in the immediate post-procedure angiogram basedon the Raymond classification. Secondary endpoints included safety during the procedure, safety after the procedure, detachment system performance, stability of the embolization, and packing efficacy.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed diagnosis of one or more intracranial aneurysm, either ruptured or unruptured.
- •Information on data collection provided to the patient or legally authorized representative and signed informed consent.
- •Aneurysm diameter ≤10mm .
- •Age range of 18 - 90.
排除标准
- •Aneurysm previously treated.
- •Aneurysm AVM related or dissecting.
- •Participation in a clinical investigation of other aneurysm treating or related devices.
- •Any condition that would preclude the conduct of protocol follow-up.
- •Aneurysm anatomy that is determined inappropriate for Axium coil placement, prior to opening of an Axium coil.
结局指标
主要结局
Anatomic occlusion of the aneurysm
时间窗: Immediately post-procedure
Occlusion of aneurysm based on the Raymond classification
次要结局
- Stability of embolization(3-6 months follow-up)
- Packing efficacy(36- months follow-up)
- Safety during the procedure(Discharge, up to two years)
- Safety post-procedure(3-6 months follow-up)
- Detachment system performance(During procedure)
研究者
研究点 (1)
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