AI-Driven CTA Reconstruction for Intracranial LVO (SMART-AI)

Shanghai Jiao Tong University

Status: Enrolling

Conditions: CT Angiography; Acute Ischemic Stroke; Endovascular Thrombectomy; Artificial Intelligence (AI)

Treatments: Behavioral: AI algorithm

Study type: Interventional

Funder types: Other

Identifiers

NCT06645405

SMART-AI

Details and patient eligibility

About

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.

Enrollment: 174 estimated patients

Sex: All

Ages: 18 to 95 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

1. Male or Female, 18 years of age or older.
2. Patients who present with signs and/or symptoms concerning acute ischemic stroke.
3. Patients who undergo noncontrast CT and CT angiography imaging.
4. 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 Criteria

1. CT imaging with severe motion artifacts.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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174 participants in 2 patient groups

Control

No Intervention group

Description:

No AI reconstruction

AI software

Experimental group

Description:

An AI approach will be used for automated segmentation and reconstruction of CTA for intracranial LVO. Physicians begin to receive reconstructions and have the authority to view AI-activated images. Diagnosis and treatment decisions will be based on the clinical evaluation and review of the images by the treating physician, as per routine standard of care.

Treatment:

Behavioral: AI algorithm