SSPC Evaluation on Carotid Artery Stenosis After Endarterectomy

NCT05296876 | Unknown DMC

• 1 other identifier: ShanghaiPudong-SSPC
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Carotid Stenosis; Carotid Artery Diseases; Carotid Artery Plaque

Keywords

carotid stenosis; carotid revascularization; symptoms; degree of stenosis; plaque; cerebral compensation

Outcome Measures

Primary Outcomes (3)

• Stroke or TIA within 12 months

  Number of participants with treatment-Stroke or TIA within 12 months

  within 12 months post-procedure

• 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

• 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 Outcomes (1)

• Myocardial Infarction or death within 1 month

  within 1 month post-procedure

Study Arms (1)

carotid endarterectomy

Patients who are treated with CEA under SSPC evaluation

Procedure: Carotid endarterectomy (CEA)

Interventions

Carotid endarterectomy (CEA) 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.

carotid endarterectomy

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with carotid artery stenosis and fulfilled the above eligible criteria in tertiary medical centers in China, will be enrolled consecutively.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Pudong Hospital: lead

Study Sites (1)

Shanghai Pudong Hospital

Shanghai, Shanghai Municipality, 201200, China

RECRUITING

MeSH Terms

Conditions

Carotid Stenosis; Carotid Artery Diseases; Plaque, Amyloid

Interventions

Endarterectomy, Carotid

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Endarterectomy; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative

Central Study Contacts

Bo Yu, M.D.

CONTACT

+8618918922698; paul.yubo@gmail.com

Jinyun Tan, M.D.

CONTACT

+8613585888537; m.tan@fudan.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2021
• First Posted: March 25, 2022
• Study Start: April 1, 2022
• Primary Completion: November 30, 2023
• Study Completion: November 30, 2023
• Last Updated: May 10, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)