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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Acute Ischemic Stroke; CT Angiography; Endovascular Thrombectomy; Artificial Intelligence (AI)
• Intervention / Treatment: Behavioral: AI algorithm

• Study Type: Interventional
• Enrollment (Estimated): 174
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yueqi Zhu; Phone Number: +86-21-66301136; Email: zhuyueqi@hotmail.com

Study Locations

• China
  • Shanghai, China, 200023
    • Recruiting
    • Shanghai Sixth People's Hospital
    • Contact: Yueqi Zhu, MD; Phone Number: +86-21-66301136; Email: zhuyueqi@hotmail.com
    • Contact: Yueqi Zhu, MD
  • Shanghai
    • Shanghai, Shanghai, China, 200233
      • Active, not recruiting
      • Shanghai Sixth People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; No AI reconstruction
Experimental: AI software; 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.	Behavioral: AI algorithm; Artificial intelligence algorithms in the automated reconstruction of intracranial large vessel occlusion (LVO); Other Names: AI approach

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AFAT	The time from target angiography to the initiation of first thrombectomy attempt (angiography-to-first-attempt time [AFAT])	Immediately after EVT

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PRT	The time from groin puncture to final arterial recanalization (puncture-to-recanalization time [PRT])	Immediately after EVT
IPT	The time from the completion of imaging to the initiation of EVT (imaging-to-puncture time [IPT])	Immediately after EVT
IRT	The time from imaging completion to final arterial recanalization (imaging-to-recanalization time [IRT])	Immediately after EVT
The rate of successful flow restoration immediately after EVT	The rate of successful flow restoration immediately after EVT	Immediately after EVT
The rate of symptomatic intracerebral hemorrhage within 24 hours post-EVT	The rate of symptomatic intracerebral hemorrhage within 24 hours post-EVT	24 hours post-EVT
The rate of procedure-related complications	The rate of procedure-related complications	Immediately after EVT
The rate of functional independence at 90 days post-EVT	The rate of functional independence at 90 days post-EVT	90 days post-EVT
The mortality rate within 90 days post-EVT	The mortality rate within 90 days post-EVT	90 days post-EVT

Collaborators and Investigators

• Sponsor: Shanghai Jiao Tong University Affiliated Sixth People's Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): October 20, 2024
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: October 9, 2024
• First Submitted That Met QC Criteria: October 15, 2024
• First Posted (Actual): October 16, 2024

Study Record Updates

• Last Update Posted (Actual): October 16, 2024
• Last Update Submitted That Met QC Criteria: October 15, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Ischemic Stroke
• Other Study ID Numbers: SMART-AI

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No