Prediction of Risk Factors for Adverse Events After Head and Neck Vascular Recanalization Surgery Based on Machine Learning Models

The Second Affiliated Hospital of Air Force Military Medical University

Prediction of risk factors for adverse events after head and neck vascular recanalization surgery based on machine learning models

Study Overview

• Status: Completed
• Conditions: Machine Learning
• Intervention / Treatment: Other: observe

• Study Type: Observational
• Enrollment (Actual): 1300

Contacts and Locations

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China, 710038
      • Tangdu Hospital

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing vascular recanalization surgery due to stroke

Description

Inclusion Criteria:

• All enrolled patients were diagnosed with clear head and neck artery stenosis and a risk event after head and neck revascularization;
• Location of lesion: origin of internal carotid artery, bifurcation of internal and external carotid arteries;
• Patients with symptomatic head and neck artery stenosis and dangerous events after head and neck blood flow reconstruction, and with a degree of stenosis ≥ 70% on non-invasive examination or stenosis ≥ 50% found on angiography;
• Asymptomatic head and neck artery stenosis and risk events after head and neck revascularization, with a degree of stenosis ≥ 70% on non-invasive examination or stenosis ≥ 60% found on angiography;
• Asymptomatic head and neck artery stenosis and dangerous events after head and neck blood flow reconstruction, with a non-invasive examination of stenosis degree less than 70%, but angiography or other examinations indicate that the stenosis lesion is in an unstable state;
• Symptomatic head and neck artery stenosis and risk events after head and neck revascularization, non-invasive examination of head and neck artery stenosis and risk events after head and neck revascularization are 50% to 69%;
• Sign the project informed consent form

Exclusion Criteria:

• Patients with poor overall condition and intolerance to general anesthesia;
• Patients with mental illness or severe mental illness;
• Severe respiratory system diseases;
• Pregnant and lactating women;
• Participating in another clinical study;
• Patients with advanced tumors or those who are expected to die within one year;

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
xi'an	Other: observe; observational study
shanxi	Other: observe; observational study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
death	one year

Secondary Outcome Measures

Outcome Measure	Time Frame
Recurrence of stroke	one year

Collaborators and Investigators

• Sponsor: Tang-Du Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Actual): November 1, 2022
• Study Completion (Actual): October 1, 2023

Study Registration Dates

• First Submitted: November 2, 2023
• First Submitted That Met QC Criteria: November 2, 2023
• First Posted (Actual): November 7, 2023

Study Record Updates

• Last Update Posted (Actual): April 16, 2025
• Last Update Submitted That Met QC Criteria: April 11, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: Bei Liu

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No