Carotid Artery Plaque, Carotid Artery Stenting, Carotid Endarterectomy
Conditions
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
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
Study design
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
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Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life rating | 30 days | Use VascuQol to evaluate quality of life scores |
| Incidence of death | 30 days | Incidence of death at 30 days follow up. |
| 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 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 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. |
| Incidence of ipsilateral stroke | 30days | Incidence of ipsilateral stroke at 30 days follow up |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
Countries
China