Segmentation and Modeling for Accurate Reconstruction of CT Angiography of Intracranial Large Vessel Occlusion with Artificial Intelligence: a Stepped-wedge, Cluster-randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 174
- 试验地点
- 3
- 主要终点
- AFAT
研究概览
简要总结
Acute ischemic stroke (AIS) caused by intracranial large vessel occlusion (LVO) in the anterior circulation significantly contributes to stroke-related disability and mortality. Recent randomized controlled trials have demonstrated substantial benefits of endovascular thrombectomy (EVT) when patients are appropriately triaged beforehand. However, accurately orienting the 'missed segment' during EVT remains challenging. Guide-wires often fail to navigate through the occlusion or are mistakenly directed into the small tranches or even cause vessel rupture. To address this clinical need, the investigators developed an artificial intelligence (AI) algorithm to automate the reconstruction of CT angiography (CTA), focusing on the occluded LVO segment. To evaluate the clinical utility of this AI algorithm, the investigators propose a prospective, stepped-wedge cluster-randomized study to determine whether integrating our AI algorithm into AIS care flow can reduce the time for first pass of the thrombus by improving the visualization of the occluded segment on CTA. Physicians will assess patient eligibility for thrombectomy, and all selected patients will receive standard care according to current guidelines. This approach is expected to enhance patient treatment outcomes for endovascular thrombectomy by leveraging readily available data.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 95 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or Female, 18 years of age or older.
- •Patients who present with signs and/or symptoms concerning acute ischemic stroke.
- •Patients who undergo noncontrast CT and CT angiography imaging.
- •Patients determined to have an intracranial large vessel occlusion (including the internal carotid artery, middle cerebral artery M1 segment, and M2 segment), and eligible for endovascular treatment.
排除标准
- •CT imaging with severe motion artifacts.
结局指标
主要结局
AFAT
时间窗: Immediately after EVT
The time from target angiography to the initiation of first thrombectomy attempt (angiography-to-first-attempt time \[AFAT\])
次要结局
- PRT(Immediately after EVT)
- IPT(Immediately after EVT)
- IRT(Immediately after EVT)
- The rate of successful flow restoration immediately after EVT(Immediately after EVT)
- The rate of symptomatic intracerebral hemorrhage within 24 hours post-EVT(24 hours post-EVT)
- The rate of procedure-related complications(Immediately after EVT)
- The rate of functional independence at 90 days post-EVT(90 days post-EVT)
- The mortality rate within 90 days post-EVT(90 days post-EVT)
研究者
Yueqi Zhu
MD
Shanghai 6th People's Hospital
