About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
None
Trial design
Sequential
Treatments tested in this trial
AI algorithm
BehavioralArtificial intelligence algorithms in the automated reconstruction of intracranial large vessel occlusion (LVO)
Treatment groups
Trial outcomes
Primary outcomes
AFAT
The time from target angiography to the initiation of first thrombectomy attempt (angiography-to-first-attempt time \[AFAT\])
Secondary outcomes
PRT
The time from groin puncture to final arterial recanalization (puncture-to-recanalization time \[PRT\])
IPT
The time from the completion of imaging to the initiation of EVT (imaging-to-puncture time \[IPT\])
IRT
The time from imaging completion to final arterial recanalization (imaging-to-recanalization time \[IRT\])
The rate of successful flow restoration immediately after EVT
The rate of successful flow restoration immediately after EVT
Sponsors and contacts
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Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Lead sponsor
Shanghai 6th People's Hospital
Sponsor institution