SSPC Evaluation on Carotid Artery Stenosis After Endarterectomy

NCT ID: NCT05296876

Last Updated: 2022-05-10

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-04-01
• Study Completion Date: 2023-11-30

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.

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.

Conditions

Carotid Stenosis; Carotid Artery Diseases; Carotid Artery Plaque

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

carotid endarterectomy

Patients who are treated with CEA under SSPC evaluation

Carotid endarterectomy (CEA)

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Pudong Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Shanghai Pudong Hospital

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Bo Yu, M.D.

Role: CONTACT

paul.yubo@gmail.com

+8618918922698

Jinyun Tan, M.D.

Role: CONTACT

m.tan@fudan.edu.cn

+8613585888537

Facility Contacts

Bo Yu, M.D.

Role: primary

paul.yubo@gmail.com

+8618918922698

Jinyun Tan, M.D.

Role: backup

m.tan@fudan.edu.cn

13585888537

Other Identifiers

ShanghaiPudong-SSPC

Identifier Type: -

Identifier Source: org_study_id