Efficacy and Prognosis of Surgical Intervention in Patients With Carotid Artery Stenosis

NCT ID: NCT06222983

Last Updated: 2024-01-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-12-31

Study Completion Date

2025-12-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study is a prospective, single center cohort study. By combining pathological examination of carotid atherosclerotic plaque with preoperative imaging examination, we explore the imaging characteristics of high-risk carotid plaque, and explore the effectiveness and safety of different surgical methods (CAS and CEA) for high-risk plaque patients with carotid stenosis.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

According to the inclusion and exclusion criteria, 100 patients with carotid artery stenosis who underwent surgical reconstruction surgery at our research center were prospectively collected from December 2023 to December 2024. Preoperative laboratory examinations such as blood routine, biochemistry, coagulation, and imaging examinations such as carotid artery ultrasound and TCCD, carotid artery ultrasound contrast, high-resolution MRI, head MRI plain scan, carotid artery CTA or DSA were completed, Based on the comprehensive evaluation of the patient's condition by the supervising physician, the appropriate surgical method (CEA or CAS) is selected. Follow up will be conducted 1/3/6/12 months after surgery to evaluate the incidence of endpoint events (cerebral infarction+all-cause death+postoperative restenosis), MoCA and MMSE cognitive scores, quality of life scores, and severe perioperative complications. At the same time, for patients undergoing CEA surgery, pathological examination of the postoperative carotid artery plaque will be conducted to clarify the nature of the plaque, and combined with imaging examination, the characteristics of high-risk carotid artery plaques will be studied

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Carotid Artery Stenting Carotid Endarterectomy Carotid Artery Plaque

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

CEA group

CEA for atherosclerosis

CEA or CAS

Intervention Type PROCEDURE

After the patient is admitted to the hospital, the supervising doctor comprehensively evaluates the patient's general condition and adopts CEA or CAS treatment. The researcher does not provide advice to the supervising doctor and only observes safety and effectiveness

CAS group

CEA for atherosclerosis

CEA or CAS

Intervention Type PROCEDURE

After the patient is admitted to the hospital, the supervising doctor comprehensively evaluates the patient's general condition and adopts CEA or CAS treatment. The researcher does not provide advice to the supervising doctor and only observes safety and effectiveness

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

CEA or CAS

After the patient is admitted to the hospital, the supervising doctor comprehensively evaluates the patient's general condition and adopts CEA or CAS treatment. The researcher does not provide advice to the supervising doctor and only observes safety and effectiveness

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. The patient is aged 45-85 years old;
2. Symptomatic patients with stenosis degree greater than 50%, or asymptomatic patients with stenosis degree between 70% and 99% (ultrasound, CT or contrast);
3. Can complete regular follow-up;
4. The patient is informed and agrees to participate in the study.

Exclusion Criteria

\-
Minimum Eligible Age

45 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Xuanwu Hospital, Beijing

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Lianrui Guo

Role: PRINCIPAL_INVESTIGATOR

Xuanwu Hospital, Beijing

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Xuanwu Hospital, Capital Medical University

Beijing, , China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Lianrui Guo, Dr.

Role: CONTACT

+8613671009746

Xixiang Gao, Dr.

Role: CONTACT

: +8613581674309

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Lianrui Guo, Dr.

Role: primary

Xixiang Gao, Dr.

Role: backup

+8613581674309

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

EPSIPCS

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.