NCT04905303撤回不适用
Prospective Multi-center, Single-arm Registry to Evaluate the Efficacy of the Solitaire AB Neurovascular Remodeling Device in the Treatment of Wide-neck Intracranial Aneurysms
Medtronic Neurovascular Clinical Affairs1 个研究点 分布在 1 个国家开始时间: 2009年2月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Stable Stent placement with complete coverage across the aneurysm neck with parent artery patency
研究概览
简要总结
The objective of the registry is to evaluate the effectiveness and performance of the Solitaire Neurovascular Remodeling Device when used with embolic coils in the treatment of intracranial aneurysms.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed diagnosis of intracranial saccular aneurysms, either ruptured or unruptured
- •Aneurysm requires current treatment with coils and a stent or aneurysm hs been previously treated with coils, but no prior placement of a stent.
- •Aneurysm has a wide neck defined as having a neck equal to or greater than 4mm or a dome-to-neck ratio of <
- •Patient is 18 years or older.
- •Patient has a Hunt & Hess score of III or less.
排除标准
- •Patient has a fusiform or dissecting aneurysm type.
- •Patient is contraindicated for either heparin or anti-platelet therapy.
- •Patient has severe allergy to IV contrast medium.
- •Patient has a known hypersensitivity to nickel-titanium.
结局指标
主要结局
Stable Stent placement with complete coverage across the aneurysm neck with parent artery patency
时间窗: Six months post-implant
次要结局
未报告次要终点
研究者
研究点 (1)
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