Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:44 PM
Ignite Modification Date:
2025-12-24 @ 11:44 PM
NCT ID:
NCT06898151
Eligibility Criteria:
Inclusion Criteria:
* Age ≥18 years;
* Diagnosed with symptomatic carotid stenosis, defined as the occurrence of sudden-onset neurological symptoms within the territory of the responsible artery within 180 days before randomization (e.g., contralateral hemiparesis, slurred speech/difficulty in expression, ipsilateral monocular vision loss, etc.);
* Stenosis located in the extracranial segment of the internal carotid artery (with or without involvement of the adjacent common carotid artery);
* Degree of stenosis in the responsible carotid artery confirmed to be ≥50% and ≤99% by CTA/MRA/DSA, based on NASCET criteria;
* Brain MRI within 72 hours before randomization indicating an acute infarction in the responsible vascular territory, characterized by high signal on DWI and low signal on ADC;
* Modified Rankin Scale (mRS) score \<3;
* Written informed consent obtained from the patient or their legal representative.
Exclusion Criteria:
* Progressive neurological deterioration within 72 hours before randomization, defined as an increase in mRS score by ≥2 points or NIHSS score by ≥4 points;
* Brain MRI within 72 hours before randomization indicating a large infarction (infarct size \> 1/2 of the middle cerebral artery territory);
* MRI evidence of hemorrhagic cerebrovascular diseases (e.g., brain tumor, brain abscess, vascular malformations) or other non-ischemic cerebrovascular diseases (e.g., multiple sclerosis);
* Non-atherosclerotic carotid stenosis (e.g., carotid artery dissection, carotid web, floating thrombus, fibromuscular dysplasia, Takayasu arteritis, etc.);
* Need for simultaneous surgical intervention for tandem lesions in the ipsilateral carotid artery or other vascular surgeries;
* History of cerebrovascular surgery within 6 months before randomization;
* Coexisting cerebrovascular stenosis requiring revascularization within 3 months after randomization;
* History of spontaneous intracranial hemorrhage within 12 months before randomization;
* Clear indication for anticoagulation therapy (suspected cardiac embolic source such as atrial fibrillation, known mechanical heart valve, or suspected infective endocarditis);
* Laboratory abnormalities, including white blood cell count \< 2×10⁹/L, hematocrit \< 30%, platelet count \< 100×10⁹/L, INR \> 1.5, or heparin-induced thrombocytopenia;
* Inability to use antiplatelet therapy due to specific reasons, such as active gastrointestinal ulcers, gastrointestinal bleeding within the past 3 months, known severe allergy, severe renal insufficiency (creatinine \>1.5 times the normal upper limit), hepatic dysfunction (ALT or AST \>2 times the normal upper limit), or severe heart failure (NYHA Class III-IV);
* Presence of other severe diseases that may affect adherence to the study protocol, such as severe infection, advanced chronic obstructive pulmonary disease (COPD), active malignant tumors, dementia, psychiatric disorders, or uncontrolled severe hypertension;
* Pregnant or breastfeeding women who are not in menopause;
* Participation in another investigational device or drug trial that may interfere with this study;
* Any other medical condition or history that, in the investigator's judgment, may affect the efficacy or safety assessment of the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06898151
Study Brief:
Protocol Section:
NCT06898151