IMPACT: International Post Market Product Surveillance Study of IntrACranial Aneurysms Treated With an Endovascular Approach
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 405
- 试验地点
- 32
- 主要终点
- Primary Performance Measure
研究概览
简要总结
IMPACT is an observational, post market study designed to provide an ongoing safety and performance evaluation of Stryker Neurovascular devices used for the treatment of intracranial aneurysms with an endovascular approach.
详细描述
IMPACT is an international, prospective, observational, multicenter, non-randomized, post market study designed to provide ongoing safety and performance evaluation on implantable devices used for the treatment of intracranial aneurysms with an endovascular approach. Data collection will also include details on adjunctive and ancillary devices used.
In addition, to gaining safety and performance data, this study will provide clinical evidence that may assist physicians in selecting an appropriate device(s) while describing treatment options used to treat patients with intracranial aneurysms.
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Primary Performance Measure
时间窗: 12 months
Composite of 100% occlusion of the target aneurysm without significant parent artery stenosis per independent core lab assessment and with no target aneurysm retreatment
Primary Safety Endpoint
时间窗: 12 months
Stroke-related neurological death or Disabling stroke in the target vessel territory as adjudicated by an independent Clinical Events Committee (CEC)
次要结局
- Secondary Performance Measures(Through 24 months)
- Secondary Safety Endpoints(Through 24 months)