The Predictive Value of Clinical Data on Perioperative and Postoperative Risk Events in Patients With Head and Neck Artery Stenosis

Sponsor
Tang-Du Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT06027463
Collaborator
(none)
1,500
1
25
60

Study Details

Study Description

Brief Summary

Predicting relevant risk factors for patients with carotid artery stenosis after different surgeries through machine learning

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    1500 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    The Predictive Value of Clinical Data on Perioperative and Postoperative Risk Events in Patients With Head and Neck Artery Stenosis
    Actual Study Start Date :
    Dec 1, 2022
    Anticipated Primary Completion Date :
    Oct 10, 2023
    Anticipated Study Completion Date :
    Dec 31, 2024

    Outcome Measures

    Primary Outcome Measures

    1. death [two years]

      Patients who died after surgery

    Secondary Outcome Measures

    1. stroke [half a year]

      Is there a recurrence of cerebral infarction within six months after surgery

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 90 Years
    Sexes Eligible for Study:
    All
    Inclusion Criteria:
    • (1) All enrolled patients were diagnosed with clear head and neck artery stenosis and a risk event after head and neck revascularization;

    (2) Location of lesion: origin of internal carotid artery, bifurcation of internal and external carotid arteries;

    (3) 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;

    (4) 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;

    (5) 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;

    (6) 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 event degree after head and neck revascularization at 50% to 69%

    Exclusion Criteria:
    • (1) Patients with poor overall condition and intolerance to general anesthesia;

    (2) Patients with mental illness or severe mental illness;

    (3) Severe respiratory system diseases;

    (4) Pregnant and lactating women;

    (5) Participating in another clinical study;

    (6) Patients with advanced tumors or those who are expected to die within one year;

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Tangdu Hospital Xi'an Shaanxi China 710038

    Sponsors and Collaborators

    • Tang-Du Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Tang-Du Hospital
    ClinicalTrials.gov Identifier:
    NCT06027463
    Other Study ID Numbers:
    • liubei
    First Posted:
    Sep 7, 2023
    Last Update Posted:
    Sep 7, 2023
    Last Verified:
    Aug 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Sep 7, 2023