SSPC Evaluation on Carotid Artery Stenosis After Endarterectomy

Sponsor

Shanghai Pudong Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05296876

Collaborator

(none)

200

Enrollment

Location

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

SSPC includes degree of Stenosis, Symptoms, Plaque stability and Compensation of the cerebral blood flow. SSPC, a comprehensive evaluation system on carotid artery stenosis, is established and advocated in this trial in order to make assessment on risk of carotid revascularization preoperatively and prediction of cerebral events postoperatively.

Condition or Disease	Intervention/Treatment	Phase
Carotid Stenosis Carotid Artery Diseases Carotid Artery Plaque	Procedure: Carotid endarterectomy (CEA)

Detailed Description

Although, cerebral perfusion and collaterals recruitment are crucial and integral to current treatment and stroke prevention paradigms, most consensus recommendations do not include assessments of cerebral hemodynamics in their management algorithms and arbitrarily focus on symptoms and degree of stenosis.

Based on four aspects of SSPC multidimensional assessment and grading, through clinical data, specimen collection, image technology of the multi-disciplinary cross research, we initially to propose a more scientific evaluation system for the perioperative period of carotid revascularization, to reveal the scientific mechanism of brain function changes after carotid revascularization, and to establish a method for the evaluation of brain function after carotid revascularization in accordance with the characteristics of Chinese lesions.

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

200 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Multi-dimensional Evaluation of Carotid Artery Stenosis and Prediction of Brain Function After Endarterectomy by SSPC System

Actual Study Start Date :

Apr 1, 2022

Anticipated Primary Completion Date :

Nov 30, 2023

Anticipated Study Completion Date :

Nov 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
carotid endarterectomy Patients who are treated with CEA under SSPC evaluation	Procedure: Carotid endarterectomy (CEA) Surgeons follow the contemporary guideline combined with their experience and preference in order to perform CEA for patients. All patients will be assessed by SSPC evaluation system before CEA. Patients will receive 100 mg of aspirin or 75 mg of clopidogrel daily starting from at least 72 h prior to the CEA procedure and continued receiving the medication indefinitely. General anesthesia is recommended for CEA and the type of CEA can be selected as conventional, eversion or a shunt or patch based on the discretion of the surgeon.

Arm

Intervention/Treatment

carotid endarterectomy

Patients who are treated with CEA under SSPC evaluation

Procedure: Carotid endarterectomy (CEA)

Surgeons follow the contemporary guideline combined with their experience and preference in order to perform CEA for patients. All patients will be assessed by SSPC evaluation system before CEA. Patients will receive 100 mg of aspirin or 75 mg of clopidogrel daily starting from at least 72 h prior to the CEA procedure and continued receiving the medication indefinitely. General anesthesia is recommended for CEA and the type of CEA can be selected as conventional, eversion or a shunt or patch based on the discretion of the surgeon.

Outcome Measures

Primary Outcome Measures

Stroke or TIA within 12 months [within 12 months post-procedure]
Number of participants with treatment-Stroke or TIA within 12 months
Immediate neurologic events within 24 hours [within 24 hours post-procedure]
Number of participants with treatment-immediate neurologic events including cerebral hyperperfusion syndrome, early-phase hypertension and cerebral hemorrhage within 24 hours
Cognition improvements [within 1, 3, 6, 12 months post-procedure]
Cognition improvements indicated by MMSE (Mini-mental State Examination) or MoCA (Montreal Cognitive Assessment) or Cantab (Cambridge Neuropsychological Test Automated Battery)

Secondary Outcome Measures

Myocardial Infarction or death within 1 month [within 1 month post-procedure]
Number of participants with treatment-Myocardial Infarction or death within 1 month

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patient or patient's legal representative have been informed of the nature of the study, agrees to participate and has signed an Ethical Committee approved consent form
Unilateral or bilateral carotid artery stenosis diagnosed by ultrasound or CT angiography.
Complete revascularization followed by carotid endarterectomy or carotid artery stenting.

Exclusion Criteria:

Patients with carotid stenosis received best medicine therapy.
Patients for whom antiplatelet therapy, anticoagulants, medium contrast, or thrombolytic drugs are contraindicated.
Patient has bleeding diathesis, coagulopathy, known hypercoagulable condition or refuses blood transfusion
female patient with childbearing potential not taking adequate contraceptives or currently breastfeeding.
Life expectancy of less than twelve months.
Patient is currently participating in another investigational drug or device study that has not completed the entire follow up period.
Patient presenting one of the following comorbid conditions: hemodialysis, elevated creatine levels (> 2.5mg/dl), recent MI or ischemic stroke occurrence (both within 30 days).
Patient unwilling or unlikely to comply with Follow-Up schedule