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NCT Number: NCT06645405

AI-Driven CTA Reconstruction for Intracranial LVO

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.

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Key information

Age range

18 year–95 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shanghai Sixth People's Hospital, Shanghai, Shanghai Municipality, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • CT imaging with severe motion artifacts.

Treatment and study plan

AI algorithm

Behavioral

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

Other names: AI approach

Primary outcomes

  1. AFAT

    Time frame: Immediately after EVT

    The time from target angiography to the initiation of first thrombectomy attempt (angiography-to-first-attempt time [AFAT])

Secondary outcomes

  1. PRT

    Time frame: Immediately after EVT

    The time from groin puncture to final arterial recanalization (puncture-to-recanalization time [PRT])

  2. IPT

    Time frame: Immediately after EVT

    The time from the completion of imaging to the initiation of EVT (imaging-to-puncture time [IPT])

  3. IRT

    Time frame: Immediately after EVT

    The time from imaging completion to final arterial recanalization (imaging-to-recanalization time [IRT])

  4. The rate of successful flow restoration immediately after EVT

    Time frame: Immediately after EVT

    The rate of successful flow restoration immediately after EVT

  5. The rate of symptomatic intracerebral hemorrhage within 24 hours post-EVT

    Time frame: 24 hours post-EVT

    The rate of symptomatic intracerebral hemorrhage within 24 hours post-EVT

  6. The rate of procedure-related complications

    Time frame: Immediately after EVT

    The rate of procedure-related complications

  7. The rate of functional independence at 90 days post-EVT

    Time frame: 90 days post-EVT

    The rate of functional independence at 90 days post-EVT

  8. The mortality rate within 90 days post-EVT

    Time frame: 90 days post-EVT

    The mortality rate within 90 days post-EVT

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Shanghai Jiao Tong University Affiliated Sixth People's Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 16, 2024
Registry last updated
Oct 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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