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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06120478
Other study ID # Bei Liu
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2019
Est. completion date October 1, 2023

Study information

Verified date November 2023
Source Tang-Du Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


Recruitment information / eligibility

Status Completed
Enrollment 1300
Est. completion date October 1, 2023
Est. primary completion date November 1, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility 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 events after head and neck revascularization are 50% to 69%; (7) Sign the project informed consent form 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;

Study Design


Related Conditions & MeSH terms


Intervention

Other:
observe
observational study

Locations

Country Name City State
China Tangdu Hospital Xi'an Shaanxi

Sponsors (1)

Lead Sponsor Collaborator
Tang-Du Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary death one year
Secondary Recurrence of stroke one year
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