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NCT Number: NCT05874596

Whole-process Quality Improvement of Endovascular Treatment Basd on an AI-aided Clinical Feedback System

A clustered randomized control trial to evaluate whether multi-aspect intervention based on an AI-aided clinical feedback system could improve the quality of EVT and functional outcome of patients.

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Key information

Conditions

Stroke, Acute Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Second Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, China

About this study

Endovascular treatment (EVT) is the standard treatment for acute ischemic stroke (AIS) caused by large vessel occlusion (LVO) according to current guidelines. However, while a rapidly-growing number of stroke centers become capable of performing EVT, the general quality of EVT remains unsatisfied, resulting in a considerable proportion of patients who could not reach functional independence. Our pre-established artificial intelligence (AI)-aided clinical feedback system could dynamically record and report key timepoints of EVT in-hospital process. Combined with multi-aspect intervention via remote/on-site surveillance and education, this may be a potential solution for quality improvement of EVT. Therefore, the aim of the study is to evaluate whether an AI-aided clinical feedback system coupled with multi-aspect intervention could improve the quality of EVT. Twenty hospitals with annual EVT cases > 30 will be 1:1 randomized into intervention group and control group. The intervention group will receive AI-based clinical feedback system coupled with multi-aspect intervention, including remote/on-site surveillance and education regarding in-hospital workflow and surgical procedures of EVT. The control group only deploys AI-aided clinical feedback system. The primary outcome is the ratio of good functional outcome at 3 month.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age > 18
  • AIS patients receiving EVT within 24 hours of stroke onset
  • Written informed consent is obtained

Exclusion criteria

  • Patients refuse to participate in this study

Treatment and study plan

AI-aided clinical feedback system coupled with multi-aspect intervention basd on Behaviour Change Wheel model

Behavioral

Interventions are developed on a psychological model, the Behaviour Change Wheel (BCW) .The fundamental of BCW consists of three essential elements: capability, motivation, and opportunity. Improving individual's capability, providing motivation, and increasing opportunities are goals of behaviour change intervention. To achieve the goals, 9 intervention components have been proposed in the BCW framework, and 6 components will be used in current study.

Primary outcomes

  1. Ratio of favorable functional outcome at 3 month

    Time frame: 3 months

    Ratio of patients with mRS ≤ 3 at 3-month follow up

Secondary outcomes

  1. Ratio of good functional outcome at 3 month

    Time frame: 3 months

    Ratio of patients with mRS ≤2 at 3-month follow up

  2. mRS score at 3 month

    Time frame: 3 months

    mRS score at 3-month follow up

  3. Mortality at 3 month

    Time frame: 3 months

    Mortality at 3-month follow up

  4. Ratio of hemorrhagic transformation at 24 hour

    Time frame: 24 hours

    Ratio of hemorrhagic transformation at 24 hour after EVT

  5. Ratio of symptomatic intracranial hemorrhage at 24 hour

    Time frame: 24 hours

    Ratio of symptomatic intracranial hemorrhage at 24 hour after EVT

  6. Door to groin puncture time

    Time frame: 24 hours

    Time interval between admission and groin puncture

  7. Ratio of door to groin puncture time < 90 min

    Time frame: 24 hours

    Time interval between admission and groin puncture <90 min

  8. Ratio of door to groin puncture time < 60 min

    Time frame: 24 hours

    Time interval between admission and groin puncture <60 min

  9. Procedural duration

    Time frame: 24 hours

    Time interval between groin puncture and last time of digital subtraction angiography

  10. Ratio of successful reperfusion

    Time frame: 24 hours

    Ratio of patients achieving modified thrombolysis in cerebral infarction (mTICI) 2b or 3

Other outcomes

  1. Ratio of favorable functional outcome at 3 month in patients within 6 hours of stroke onset

    Time frame: 3 months

    Ratio of mRS > 2 at 3 month follow-up in patients within 6 hours of stroke onset

  2. Door to groin puncture time in patients within 6 hours of stroke onset

    Time frame: 24 hours

    Time interval between admission and groin puncture in patients within 6 hours of stroke onset

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Registry information

Official study title

Whole-process Quality Improvement of Patients With Acute Ischemic Stroke Undergoing Endovascular Treatment Based on an Artificial Intelligence-aided Clinical Feedback System

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
May 25, 2023
Registry last updated
Nov 20, 2025

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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