C-arm Cone Beam CTP Guided Cerebrovascular Interventions: Evaluating Predictability and Accuracy for the Treatment of Acute Cerebral Ischemia in the Angiography Suite
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Feasibility measured as the amount of time from hospital arrival to the angiography suite
研究概览
简要总结
The study objective for the Phase 2 of this research is to demonstrate and confirm the substantial time savings that can be obtained using cone beam computed tomography (CB-CT) for both complete image acquisition and rapid image reconstruction in a Direct to Angio paradigm (One Stop Shop) for selected acute ischemic stroke (AIS) patients.
详细描述
Phase 2 of this research is aimed at validating the feasibility and time savings of bringing selected acute ischemic stroke patients with suspected large vessel occlusion directly on hospital arrival to the angiography suite, avoiding the emergency room and conventional MD-CT imaging. In order to make this phase of the study more robust and to reduce bias on image assessment we will prospectively randomize the patients in a 2:1 fashion to either direct to angio for CB-CT imaging or MD-CT imaging in the emergency room. A total of 60 CB-CT subjects and 30 MD-CT subjects will comprise this cohort. Entrance criteria will be identical to those in Phase 1, except the NIHSS must be greater than 8 which is clinically correlative with a likely large vessel occlusion and, since this is standard of care imaging for acute ischemic stroke, GFR will be removed as an exclusionary criteria.
The Phase 1 of this research was registered to NCT03232151.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with acute ischemic stroke presenting within 24 hours of onset
- •Patients that present with a large artery occlusion
- •Adults 18 years of age or older.
- •Patients of childbearing potential must not be pregnant.
- •National Institutes of Health Stroke Scale (NIHSS) of <8
- •No severe co-morbidities
排除标准
- •Patients that are pregnant
- •History of severe renal disease (e.g. stage 4-5)
- •History of renal transplant
结局指标
主要结局
Feasibility measured as the amount of time from hospital arrival to the angiography suite
时间窗: 1 visit (up to 120 minutes)
Phase 2 of the human subject study aims to further assess the feasibility as a measure the amount of time it takes to bring selected acute ischemic stroke patients with suspected large vessel occlusion directly on hospital arrival to the angiography suite, avoiding the emergency room and conventional MD-CT imaging.
次要结局
未报告次要终点