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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
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06222983
Enrollment
100
Registered
2024-01-25
Start date
2023-12-31
Completion date
2025-12-01
Last updated
2024-01-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carotid Artery Plaque, Carotid Artery Stenting, Carotid Endarterectomy

Keywords

Carotid Revascularization, Carotid Artery Stenting, Carotid Endarterectomy

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

Interventions

PROCEDURECEA 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

Sponsors

Xuanwu Hospital, Beijing
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
45 Years to 80 Years
Healthy volunteers
No

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

\-

Design outcomes

Primary

MeasureTime frameDescription
Quality of life rating30 daysUse VascuQol to evaluate quality of life scores
Incidence of death30 daysIncidence of death at 30 days follow up.
Carotid restenosis rate3,6,12 monthsCarotid restenosis was defined as restenosis ≥50% after carotid revascularization, that is, peak systolic velocity ratio (PSVR) ≥2.0 on ultrasound examination.
Improvement in cognitive function0,3,6,12monthsCognitive function was assessed by Mini-mental State Examination (MMSE) during follow up.
Any Periprocedural Stroke, Myocardial Infarction, or Death During1 month Peri-procedural Period, and Postprocedural Ipsilateral Stroke 1 to 12-months.0 to 12 monthsComposite 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 complications30daysRate 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.
Incidence of ipsilateral stroke30daysIncidence of ipsilateral stroke at 30 days follow up

Secondary

MeasureTime frameDescription
CT and pathological indicators related to high-risk plaques0-7daysCT 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 plaques0-7daysMRI are used to visualize plaques, combined with pathological examination, to identify the imaging characteristics of high-risk plaques
Ultrasound and pathological indicators related to high-risk plaques0-7daysUltrasound are used to visualize plaques, combined with pathological examination, to identify the imaging characteristics of high-risk plaques

Countries

China

Contacts

Primary ContactLianrui Guo, Dr.
lianguiguo@sina.com+8613671009746
Backup ContactXixiang Gao, Dr.
vascsurgeon@163.com: +8613581674309

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026