AI algorithm
BehavioralArtificial intelligence algorithms in the automated reconstruction of intracranial large vessel occlusion (LVO)
Other names: AI approach
NCT Number: NCT06645405
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.
Interested in participating?
Request Info18 year–95 year
All sexes
Interventional
Not applicable
Shanghai Sixth People's Hospital, Shanghai, Shanghai Municipality, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Artificial intelligence algorithms in the automated reconstruction of intracranial large vessel occlusion (LVO)
Other names: AI approach
Time frame: Immediately after EVT
The time from target angiography to the initiation of first thrombectomy attempt (angiography-to-first-attempt time [AFAT])
Time frame: Immediately after EVT
The time from groin puncture to final arterial recanalization (puncture-to-recanalization time [PRT])
Time frame: Immediately after EVT
The time from the completion of imaging to the initiation of EVT (imaging-to-puncture time [IPT])
Time frame: Immediately after EVT
The time from imaging completion to final arterial recanalization (imaging-to-recanalization time [IRT])
Time frame: Immediately after EVT
The rate of successful flow restoration immediately after EVT
Time frame: 24 hours post-EVT
The rate of symptomatic intracerebral hemorrhage within 24 hours post-EVT
Time frame: Immediately after EVT
The rate of procedure-related complications
Time frame: 90 days post-EVT
The rate of functional independence at 90 days post-EVT
Time frame: 90 days post-EVT
The mortality rate within 90 days post-EVT
Contact information is provided by the study sponsor or research team.
Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Other
Segmentation and Modeling for Accurate Reconstruction of CT Angiography of Intracranial Large Vessel Occlusion with Artificial Intelligence: a Stepped-wedge, Cluster-randomized Controlled Trial
Acronym: SMART-AI
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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