Clinical trial NCT06222983: Efficacy and Prognosis of Surgical Intervention in Patients With Carotid Artery Stenosis
Official title: A Prospective Cohort Study on the Efficacy and Prognosis of Surgical Intervention in Patients With Carotid Artery Stenosis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Carotid Artery Stenting
Carotid Endarterectomy
Carotid Artery Plaque
Keywords: Carotid Revascularization
Carotid Artery Stenting
Carotid Endarterectomy
Lead sponsor: Xuanwu Hospital, Beijing
Sponsor class: OTHER
First posted: 2024-01-25
Enrollment: 100
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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

Eligibility criteria: 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:

-

Primary outcomes:
measure: Any Periprocedural Stroke, Myocardial Infarction, or Death During1 month Peri-procedural Period, and Postprocedural Ipsilateral Stroke 1 to 12-months.
timeFrame: 0 to 12 months
measure: Rate of complications
timeFrame: 30days
measure: Incidence of ipsilateral stroke
timeFrame: 30days
measure: Incidence of death
timeFrame: 30 days
measure: Carotid restenosis rate
timeFrame: 3,6,12 months
measure: Improvement in cognitive function
timeFrame: 0,3,6,12months
measure: Improvement in cognitive function
timeFrame: 0,3,6,12months
measure: Quality of life rating
timeFrame: 30 days
Secondary outcomes:
measure: Ultrasound and pathological indicators related to high-risk plaques
timeFrame: 0-7days
measure: CT and pathological indicators related to high-risk plaques
timeFrame: 0-7days
measure: MRI and pathological indicators related to high-risk plaques
timeFrame: 0-7days
Other outcomes:
Locations:
city: Beijing
country: China
facility: Xuanwu Hospital, Capital Medical University
Study officials:
affiliation: Xuanwu Hospital, Beijing
name: Lianrui Guo
role: PRINCIPAL_INVESTIGATOR
References: