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

Carotid Artery Plaque Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06222983
• Other study ID #: EPSIPCS
• Status: Recruiting
• Start date: December 31, 2023
• Est. completion date: December 1, 2025

Study information

• Verified date: January 2024
• Source: Xuanwu Hospital, Beijing
• Contact: Lianrui Guo, Dr.
• Phone: +8613671009746
• Email: lianguiguo[@]sina.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 1, 2025
• Est. primary completion date: December 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 80 Years

Eligibility

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: -

Related Conditions & MeSH terms

• Carotid Artery Plaque
• Carotid Artery Stenting
• Carotid Endarterectomy
• Carotid Stenosis

Intervention

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

Locations

Country	Name	City	State
China	Xuanwu Hospital, Capital Medical University	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Xuanwu Hospital, Beijing

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Incidence of ipsilateral stroke	Incidence of ipsilateral stroke at 30 days follow up	30days
Primary	Incidence of death	Incidence of death at 30 days follow up.	30 days
Primary	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
Primary	Improvement in cognitive function	Cognitive function was assessed by Mini-mental State Examination (MMSE) during follow up.	0,3,6,12months
Primary	Improvement in cognitive function	Cognitive function was assessed by Montreal Cognitive Assessment Scale (MoCA) during follow up.	0,3,6,12months
Primary	Quality of life rating	Use VascuQol to evaluate quality of life scores	30 days
Secondary	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
Secondary	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
Secondary	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