AI-Driven CTA Reconstruction for Intracranial LVO

Last updated: October 15, 2024
Sponsor: Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Stroke

Cardiac Ischemia

Blood Clots

Treatment

AI algorithm

Clinical Study ID

NCT06645405
SMART-AI
  • Ages 18-95
  • All Genders

Study 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 Criteria

Inclusion

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.

Study Design

Total Participants: 174
Treatment Group(s): 1
Primary Treatment: AI algorithm
Phase:
Study Start date:
October 20, 2024
Estimated Completion Date:
December 31, 2025

Connect with a study center

  • Shanghai Sixth People's Hospital

    Shanghai, 200023
    China

    Active - Recruiting

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