Clinical trial NCT05296876: SSPC Evaluation on Carotid Artery Stenosis After Endarterectomy
Official title: Multi-dimensional Evaluation of Carotid Artery Stenosis and Prediction of Brain Function After Endarterectomy by SSPC System
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Carotid Stenosis
Carotid Artery Diseases
Carotid Artery Plaque
Keywords: carotid stenosis
carotid revascularization
symptoms
degree of stenosis
plaque
cerebral compensation
Lead sponsor: Shanghai Pudong Hospital
Sponsor class: OTHER
First posted: 2022-03-25
Enrollment: 200
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Stroke or TIA within 12 months
timeFrame: within 12 months post-procedure
measure: Immediate neurologic events within 24 hours
timeFrame: within 24 hours post-procedure
measure: Cognition improvements
timeFrame: within 1, 3, 6, 12 months post-procedure
Secondary outcomes:
measure: Myocardial Infarction or death within 1 month
timeFrame: within 1 month post-procedure
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Pudong Hospital
state: Shanghai
Study officials:
References: