RecruitingNot ApplicableNCT06645405

AI-Driven CTA Reconstruction for Intracranial LVO

Segmentation and Modeling for Accurate Reconstruction of CT Angiography of Intracranial Large Vessel Occlusion with Artificial Intelligence: a Stepped-wedge, Cluster-randomized Controlled Trial


Sponsor

Shanghai Jiao Tong University Affiliated Sixth People's Hospital

Enrollment

174 participants

Start Date

Oct 20, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 18 YearsMax Age: 95 Years

Inclusion Criteria4

  • 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.

Exclusion Criteria1

  • \) CT imaging with severe motion artifacts.

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Interventions

BEHAVIORALAI algorithm

Artificial intelligence algorithms in the automated reconstruction of intracranial large vessel occlusion (LVO)


Locations(2)

Shanghai Sixth People's Hospital

Shanghai, Shanghai Municipality, China

Shanghai Sixth People's Hospital

Shanghai, China

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NCT06645405


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