Clinical trial NCT06645405: AI-Driven CTA Reconstruction for Intracranial LVO
Official 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Acute Ischemic Stroke
Artificial Intelligence (AI)
Endovascular Thrombectomy
CT Angiography
Lead sponsor: Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Sponsor class: OTHER
First posted: 2024-10-16
Enrollment: 174
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: SUPPORTIVE_CARE

Brief 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 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.

Primary outcomes:
measure: AFAT
timeFrame: Immediately after EVT
Secondary outcomes:
measure: PRT
timeFrame: Immediately after EVT
measure: IPT
timeFrame: Immediately after EVT
measure: IRT
timeFrame: Immediately after EVT
measure: The rate of successful flow restoration immediately after EVT
timeFrame: Immediately after EVT
measure: The rate of symptomatic intracerebral hemorrhage within 24 hours post-EVT
timeFrame: 24 hours post-EVT
measure: The rate of procedure-related complications
timeFrame: Immediately after EVT
measure: The rate of functional independence at 90 days post-EVT
timeFrame: 90 days post-EVT
measure: The mortality rate within 90 days post-EVT
timeFrame: 90 days post-EVT
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Sixth People's Hospital
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Sixth People's Hospital
Study officials:
References: