Timing of carotid surgery or stenting after a symptomatic carotid event

Carotid Endarterectomy and Stenting Timing：The CEST Trial

This study will test whether doing carotid artery repair (surgery or stenting) within 48 hours versus waiting more than 14 days works better and is safer for adults with symptomatic carotid narrowing and MRI-confirmed acute infarction.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 268 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Xuanwu Hospital, Beijing (Academic / other)
• Locations: 1 site (Beijing)
• Trial ID: NCT06898151 on ClinicalTrials.gov

What this trial studies

Adults with symptomatic extracranial carotid stenosis (50–99%) and an MRI showing acute infarction in the relevant vascular territory are assigned to receive carotid endarterectomy or carotid artery stenting plus best medical therapy either within 48 hours or after 14 days. Eligibility requires recent symptoms within 180 days, a qualifying degree of stenosis by CTA/MRA/DSA using NASCET criteria, and an mRS <3. The trial compares safety outcomes (procedural stroke, death, or complications) and efficacy (prevention of recurrent ischemic events) between the early and delayed revascularization groups. Procedures are performed at Xuanwu Hospital with standard perioperative medical management.

Who should consider this trial

Good fit: Adults (≥18 years) with symptomatic extracranial carotid stenosis of 50–99%, MRI within 72 hours showing DWI/ADC-confirmed acute infarction in the responsible territory, and an mRS less than 3 who can consent are ideal candidates.

Not a fit: Patients with progressive neurological deterioration, severe disability (mRS ≥3), no MRI-confirmed acute infarction, or carotid disease not in the extracranial internal carotid artery are unlikely to gain from this protocol.

Why it matters

Potential benefit: If successful, this could identify an optimal timing strategy that reduces the risk of recurrent stroke and improves outcomes after symptomatic carotid stenosis.

How similar studies have performed: Prior meta-analyses and guideline recommendations support earlier carotid revascularization (within about 14 days) to lower recurrent stroke risk, but randomized data specifically comparing ultra-early (≤48 hours) versus delayed (>14 days) procedures remain limited.

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.

Where this trial is running

Beijing

• Xuanwu Hospital, Capital Medical University. — Beijing, China (Recruiting)

Study contacts

• Study coordinator: Yan Prof. Ma, MD

Conditions Carotid Endarterectomy; Carotid Stenting; Timing of carotid artery revascularization