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

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Capital Medical University

Status

Enrolling

Conditions

Carotid Artery Plaque
Carotid Artery Stenting
Carotid Endarterectomy

Treatments

Procedure: CEA or CAS

Study type

Observational

Funder types

Other

Identifiers

NCT06222983
EPSIPCS

Details and patient eligibility

About

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.

Full description

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

Enrollment

100 estimated patients

Sex

All

Ages

45 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

100 participants in 2 patient groups

CEA group
Description:
CEA for atherosclerosis
Treatment:
Procedure: CEA or CAS
CAS group
Description:
CEA for atherosclerosis
Treatment:
Procedure: CEA or CAS

Trial contacts and locations

1

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Central trial contact

Xixiang Gao, Dr.; Lianrui Guo, Dr.

Data sourced from clinicaltrials.gov

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