NCT06893588招募中不适用
Prospective, Open-Label, Multi-Center ProceDural Data CollectIon Case Registry on NeVa VS for CerebraL VAsospasm ManagemenT in Post SAH PatiEnts (The DILATE Registry)
Vesalio16 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2025年4月14日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 16
- 主要终点
- Improvement in target vessel diameter following NeVa VS use
研究概览
简要总结
A multi-center, observational registry study intended to assess the HDE-approved NeVa VS cerebral artery dilation device in patients with symptomatic cerebral vasospasm caused by aneurysmal subarachnoid hemorrhage (aSAH)
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
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Symptomatic cerebral vasospasm secondary to aneurysmal subarachnoid hemorrhage (aSAH) in the internal carotid artery (ICA), middle cerebral artery (MCA), anterior cerebral artery (ACA), posterior cerebral artery (PCA), or basilar artery (BA)
- •Vessel dilation procedure was performed with the NeVa VS
- •Subject or legal representative is able and willing to give informed consent within 3 days (72 hours) post-index procedure
排除标准
- 未提供
结局指标
主要结局
Improvement in target vessel diameter following NeVa VS use
时间窗: Up to 1 hour post procedure
次要结局
未报告次要终点
研究者
研究点 (16)
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