NCT06120478

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2022

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 2, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 7, 2023

Completed
Last Updated

April 16, 2025

Status Verified

April 1, 2025

Enrollment Period

3.8 years

First QC Date

November 2, 2023

Last Update Submit

April 11, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • death

    one year

Secondary Outcomes (1)

  • Recurrence of stroke

    one year

Study Arms (2)

xi'an

Other: observe

shanxi

Other: observe

Interventions

observeOTHER

observational study

shanxixi'an

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing vascular recanalization surgery due to stroke

You may qualify if:

  • 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

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tangdu Hospital

Xi'an, Shaanxi, 710038, China

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
6 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 2, 2023

First Posted

November 7, 2023

Study Start

January 1, 2019

Primary Completion

November 1, 2022

Study Completion

October 1, 2023

Last Updated

April 16, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will share

Locations