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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 95
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Shanghai Sixth People's Hospital
RECRUITING
Shanghai
Shanghai Sixth People's Hospital
ACTIVE_NOT_RECRUITING
Shanghai
Contact Information
Primary
Yueqi Zhu
zhuyueqi@hotmail.com
+86-21-66301136
Time Frame
Start Date: 2024-10-20
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 174
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Shanghai Jiao Tong University Affiliated Sixth People's Hospital

This content was sourced from clinicaltrials.gov