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

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.

Study Overview

• Status: Recruiting
• Conditions: Carotid Artery Plaque; Carotid Artery Stenting; Carotid Endarterectomy
• Intervention / Treatment: Procedure: CEA or CAS

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 Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Lianrui Guo, Dr.; Phone Number: +8613671009746; Email: lianguiguo@sina.com
• Study Contact Backup: Name: Xixiang Gao, Dr.; Phone Number: : +8613581674309; Email: vascsurgeon@163.com

Study Locations

• China
  • Beijing, China
    • Recruiting
    • Xuanwu Hospital, Capital Medical University
    • Contact: Xixiang Gao, Dr.; Phone Number: +8613581674309; Email: vascsurgeon@163.com
    • Contact: Lianrui Guo, Dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

1. Patients with spontaneous intracranial hemorrhage within the past 12 months;
2. Patients with larger intracranial aneurysms (diameter>5mm) that cannot be treated in advance or at the same time;
3. Patients with chronic complete occlusion without obvious symptoms of cerebral ischemia;
4. Patients with severe dementia;
5. Carotid artery opening lesion;
6. Severe intracranial serial stenosis lesions;
7. Carotid artery dissection;
8. Lesions with combined carotid artery aneurysm;
9. Patients with generally poor physical condition who cannot tolerate surgery;
10. Coagulation dysfunction, contraindications to heparin and antiplatelet drugs;
11. Patients who are participating in clinical trials of other drugs or devices but have not reached the trial endpoint;
12. Pregnant and lactating women;
13. The researchers believe that patients who are not suitable to participate in this trial.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
CEA group; CEA for atherosclerosis	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
CAS group; CEA for atherosclerosis	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Any Periprocedural Stroke, Myocardial Infarction, or Death During1 month Peri-procedural Period, and Postprocedural Ipsilateral Stroke 1 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.	0 to 12 months
Incidence of death	Incidence of death at 30 days follow up.	30 days
Rate of complications	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.	30days
Incidence of ipsilateral stroke	Incidence of ipsilateral stroke at 30 days follow up	30days
Carotid restenosis rate	Carotid restenosis was defined as restenosis ≥50% after carotid revascularization, that is, peak systolic velocity ratio (PSVR) ≥2.0 on ultrasound examination.	3,6,12 months
Improvement in cognitive function	Cognitive function was assessed by Mini-mental State Examination (MMSE) during follow up.	0,3,6,12months
Improvement in cognitive function	Cognitive function was assessed by Montreal Cognitive Assessment Scale (MoCA) during follow up.	0,3,6,12months
Quality of life rating	Use VascuQol to evaluate quality of life scores	30 days

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Xuanwu Hospital, Beijing
• Investigators: Principal Investigator: Lianrui Guo, Xuanwu Hospital, Beijing

Study record dates

Study Major Dates

• Study Start (Actual): December 31, 2023
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: January 7, 2024
• First Submitted That Met QC Criteria: January 24, 2024
• First Posted (Actual): January 25, 2024

Study Record Updates

• Last Update Posted (Actual): January 25, 2024
• Last Update Submitted That Met QC Criteria: January 24, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Carotid Revascularization; Carotid Artery Stenting; Carotid Endarterectomy
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arterial Occlusive Diseases; Carotid Artery Diseases; Carotid Stenosis
• Other Study ID Numbers: EPSIPCS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No