Clinical Trials in China / NCT06898151
Recruiting
Not applicable
Carotid Endarterectomy and Stenting Timing
NCT06898151 · tracked via the Priya Life Science China tracker
Condition(s) studied
Carotid EndarterectomyCarotid Stenting
Investigational drug(s) / intervention(s)
CEA/CAS plus best medical treatment
CEA/CAS plus best medical treatment: Timing of CEA/CAS plus best medical treatment
Study summary
To compare the safety and efficacy of carotid revascularization performed within 48 hours versus after 14 days in patients with symptomatic carotid stenosis accompanied with MRI-confirmed acute infarction (high signal on diffusion-weighted imaging accompanied by low apparent diffusion coefficient signal) in the responsible vascular territory.
Eligibility
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.
Primary outcome measure(s)
- Any stroke, death, myocardial infarction, or urgent revascularization from randomization to 30 days, or an ischemic stroke in the responsible vascular territory occurring between 30 days and 3 months post-randomization. — From randomization to 3 months
Urgent revascularization indicates the rescue surgery when transient ischemic attack happened during medical treatment. TIA: any temporary neurological deficit lasting less than 24 hours confirmed by a certified neurologist. Stroke including ischemic and hemorrhagic stroke within the territory of the treated carotid artery as confirmed by cerebral MRI or CT. All cause death will be confirmed when mRS scale is 6. Myocardial infarction: detection of rise and/or fall of cardiac biomarkers with at least one value above the 99th percentile of the upper reference limit together with evidence of myocardial ischaemia with at least one of the following: symptoms of ischaemia, ECG changes indicative of new ischaemia (new ST-T changes or new left bundle branch block, new onset of pathological Q waves in ECG, imaging evidence of new loss of viable myocardium or new regional wall motion abnormolity.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Xuanwu Hospital, Capital Medical University. | Beijing | China | Recruiting |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06898151 on ClinicalTrials.gov ↗ ← All trials in China