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

April 11, 2025 updated by: Tang-Du Hospital
The Predictive Value of Clinical Data on Perioperative and Postoperative Risk Events in Patients With Head and Neck Artery Stenosis

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

1500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

The target population of the study is adults aged 18-90 who have been diagnosed with head and neck artery stenosis and risk events after head and neck revascularization and seek medical treatment in neurosurgery departments of tertiary comprehensive hospitals.

Description

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;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
xi'an/Tangdu hospital
Procedure: Head and neck vascular recanalization
Head and neck vascular recanalization

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence of cerebral infarction
Time Frame: half a year
Postoperative recurrence of cerebral infarction in patients
half a year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Death
Time Frame: one year
Patients who died after surgery
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tang-Du Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2022

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

August 31, 2023

First Submitted That Met QC Criteria

August 31, 2023

First Posted (Actual)

September 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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • liubei

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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