Postoperative Risk Factors for Patients With Carotid Artery StenosisNCT06027463
The Predictive Value of Clinical Data on Perioperative and Postoperative Risk Events in Patients With Head and Neck Artery Stenosis
An observational study of Postoperative Risk Factors for Patients With Carotid Artery Stenosis, run by Tang-Du Hospital at 1 site in China.
Trial summary
The Predictive Value of Clinical Data on Perioperative and Postoperative Risk Events in Patients With Head and Neck Artery Stenosis Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Postoperative Risk Factors for Patients With Carotid Artery Stenosis
- What is being tested?
- Head and neck vascular recanalization
- Type of treatment
- Surgery or procedure
- How many people
- 1,500 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2022to 31 Dec 2026
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Adult, Older adult
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.
Who may be able to join
- (1) 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 event degree after head and neck revascularization at 50% to 69%
Who cannot join
- (1) 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;
Trial locations and contacts
1 site in 1 country.
About this study
The Predictive Value of Clinical Data on Perioperative and Postoperative Risk Events in Patients With Head and Neck Artery Stenosis
- Being tested
- Head and neck vascular recanalization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Head and neck vascular recanalizationProcedure or surgery
Head and neck vascular recanalization
| Study group | Role | What they receive |
|---|---|---|
| xi'an/Tangdu hospital | Not described Receives: Procedure: Head and neck vascular recanalization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence of cerebral infarction
Postoperative recurrence of cerebral infarction in patients
Measured: half a year
Secondary outcomes (1)
Death
Patients who died after surgery
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2023
- Study start1 Dec 2022
- Primary completion30 Jun 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Why it stopped: paper is done, but not published.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Risk Factors for Patients With Carotid Artery StenosisStudies of the same condition, open and under way.
- More trials run by Tang-Du HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Tang-Du Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06027463
- Sponsor's protocol ID
- liubei
- Status last verified
- Apr 2025
- First submitted
- 31 Aug 2023
- Last updated
- 16 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Predictive Value of Clinical Data on Perioperative and Postoperative Risk Events in Patients With Head and Neck Artery Stenosis
- ClinicalTrials.gov ID
- NCT06027463
- Acronym / sponsor ID
- liubei
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: paper is done, but not published.
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Tang-Du HospitalUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 7 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Predictive Value of Clinical Data on Perioperative and Postoperative Risk Events in Patients With Head and Neck Artery Stenosis
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| xi'an/Tangdu hospital | – | Procedure: Head and neck vascular recanalization |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- (1) All enrolled patients were diagnosed with clear head and neck artery stenosis and a risk event after head and neck revascularization;
Key exclusion criteria (6 listed)
- (1) Patients with poor overall condition and intolerance to general anesthesia;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Head and neck vascular recanalizationHead and neck vascular recanalization | Procedure or surgery | xi'an/Tangdu hospital |
Primary outcome
Recurrence of cerebral infarction
Time frame: half a year
Postoperative recurrence of cerebral infarction in patients
1 secondary outcome
Death
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2025.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Risk Factors for Patients With Carotid Artery Stenosis, run by Tang-Du Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 16 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence of cerebral infarction (time frame: half a year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2025.