A Prospective Cohort Study on the Efficacy and Prognosis of Surgical Intervention in Patients With Carotid Artery Stenosis
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Carotid Artery Stenting
- Sponsor
- Xuanwu Hospital, Beijing
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Incidence of ipsilateral stroke
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
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
Investigators
Eligibility Criteria
Inclusion Criteria
- •The patient is aged 45-85 years old;
- •Symptomatic patients with stenosis degree greater than 50%, or asymptomatic patients with stenosis degree between 70% and 99% (ultrasound, CT or contrast);
- •Can complete regular follow-up;
- •The patient is informed and agrees to participate in the study.
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Incidence of ipsilateral stroke
Time Frame: 30days
Incidence of ipsilateral stroke at 30 days follow up
Incidence of death
Time Frame: 30 days
Incidence of death at 30 days follow up.
Quality of life rating
Time Frame: 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.
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 0,3,6,12months
Cognitive function was assessed by Montreal Cognitive Assessment Scale (MoCA) during follow up.
Secondary Outcomes
- Ultrasound and pathological indicators related to high-risk plaques(0-7days)
- MRI and pathological indicators related to high-risk plaques(0-7days)
- CT and pathological indicators related to high-risk plaques(0-7days)