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

Recruiting

• Conditions: Carotid Artery Plaque; Carotid Artery Stenting; Carotid Endarterectomy
• Interventions: Procedure: CEA or CAS

• Registration Number: NCT06222983
• Lead Sponsor: Xuanwu Hospital, Beijing

Brief 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

Study Timeline

• Study Start: 2023-12-31
• Status Verified: 2024-01
• Study First Submitted: 2024-01-07
• Study First Submitted QC: 2024-01-24
• Last Update Submitted: 2024-01-24
• Study First Posted: 2024-01-25
• Last Update Posted: 2024-01-25
• Primary Completion: 2025-12-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
CAS group	CEA or CAS	CEA for atherosclerosis
CEA group	CEA or CAS	CEA for atherosclerosis

Primary Outcome Measures

Name	Time	Method
Incidence of ipsilateral stroke	30days	Incidence of ipsilateral stroke at 30 days follow up
Incidence of death	30 days	Incidence of death at 30 days follow up.
Quality of life rating	30 days	Use VascuQol to evaluate quality of life scores
Any Periprocedural Stroke, Myocardial Infarction, or Death During1 month Peri-procedural Period, and Postprocedural Ipsilateral Stroke 1 to 12-months.	0 to 12 months	Composite of any periprocedural stroke (ipsilateral or contralateral; major or minor), myocardial infarction, or death during1 month peri-procedural period, and postprocedural ipsilateral stroke 1 to 12-months.
Rate of complications	30days	Rate of complications within 30 days, complications include cranial nerve and peripheral nerve injury, vascular injury, wound complications as neck incision or related to puncture site, and other (such as anesthesia) complications.
Carotid restenosis rate	3,6,12 months	Carotid restenosis was defined as restenosis ≥50% after carotid revascularization, that is, peak systolic velocity ratio (PSVR) ≥2.0 on ultrasound examination.
Improvement in cognitive function	0,3,6,12months	Cognitive function was assessed by Montreal Cognitive Assessment Scale (MoCA) during follow up.

Secondary Outcome Measures

Name	Time	Method
Ultrasound and pathological indicators related to high-risk plaques	0-7days	Ultrasound are used to visualize plaques, combined with pathological examination, to identify the imaging characteristics of high-risk plaques
MRI and pathological indicators related to high-risk plaques	0-7days	MRI are used to visualize plaques, combined with pathological examination, to identify the imaging characteristics of high-risk plaques
CT and pathological indicators related to high-risk plaques	0-7days	CT are used to visualize plaques, combined with pathological examination, to identify the imaging characteristics of high-risk plaques

Trial Locations

Locations (1)

Xuanwu Hospital, Capital Medical University; 🇨🇳 Beijing, China