NCT06222983

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

A Prospective Cohort Study on the Efficacy and Prognosis of Surgical Intervention in Patients With Carotid Artery Stenosis

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: Xuanwu Hospital, Beijing · Academic / Other
• Sex: All
• Age: 45 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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

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

• Carotid Artery Stenting
• Carotid Endarterectomy
• Carotid Artery Plaque

Interventions

Type	Name	Description
PROCEDURE	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

Timeline

• Start date: 2023-12-31
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2024-01-25
• Last updated: 2024-01-25

Locations

1 site across 1 country: China