SSPC Evaluation on Carotid Artery Stenosis After Endarterectomy

Carotid Stenosis Clinical Trial

— SSPC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05296876
• Other study ID #: ShanghaiPudong-SSPC
• Status: Recruiting
• Start date: April 1, 2022
• Est. completion date: November 30, 2023

Study information

• Verified date: May 2022
• Source: Shanghai Pudong Hospital
• Contact: Bo Yu, M.D.
• Phone: +8618918922698
• Email: paul.yubo[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: November 30, 2023
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 90 Years

Eligibility

Inclusion Criteria:

1. 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

2. Unilateral or bilateral carotid artery stenosis diagnosed by ultrasound or CT angiography.

3. Complete revascularization followed by carotid endarterectomy or carotid artery stenting.

Exclusion Criteria:

1. Patients with carotid stenosis received best medicine therapy.

2. Patients for whom antiplatelet therapy, anticoagulants, medium contrast, or thrombolytic drugs are contraindicated.

3. Patient has bleeding diathesis, coagulopathy, known hypercoagulable condition or refuses blood transfusion

4. female patient with childbearing potential not taking adequate contraceptives or currently breastfeeding.

5. Life expectancy of less than twelve months.

6. Patient is currently participating in another investigational drug or device study that has not completed the entire follow up period.

7. 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).

8. Patient unwilling or unlikely to comply with Follow-Up schedule

Related Conditions & MeSH terms

• Carotid Artery Diseases
• Carotid Artery Plaque
• Carotid Stenosis
• Constriction, Pathologic

Intervention

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.

Locations

Country	Name	City	State
China	Shanghai Pudong Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Pudong Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stroke or TIA within 12 months	Number of participants with treatment-Stroke or TIA within 12 months	within 12 months post-procedure
Primary	Immediate neurologic events within 24 hours	Number of participants with treatment-immediate neurologic events including cerebral hyperperfusion syndrome, early-phase hypertension and cerebral hemorrhage within 24 hours	within 24 hours post-procedure
Primary	Cognition improvements	Cognition improvements indicated by MMSE (Mini-mental State Examination) or MoCA (Montreal Cognitive Assessment) or Cantab (Cambridge Neuropsychological Test Automated Battery)	within 1, 3, 6, 12 months post-procedure
Secondary	Myocardial Infarction or death within 1 month	Number of participants with treatment-Myocardial Infarction or death within 1 month	within 1 month post-procedure