Carotid Endarterectomy and Stenting Timing: The CEST Trial
Led by Xuanwu Hospital, Beijing · Updated on 2025-08-15
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26 weeks
Total Duration
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What this Trial Is About
This research aims to compare the safety and effectiveness of carotid artery revascularization performed within 48 hours versus after 14 days in patients with symptomatic carotid stenosis who have MRI-confirmed acute infarction in the affected blood vessel area. Carotid artery stenosis is a major cause of stroke, and timely revascularization combined with medication is important to prevent further strokes. Despite recommendations for early surgery, concerns about complications have limited early procedures in some regions.
Participants will receive carotid endarterectomy (CEA) or carotid artery stenting (CAS) along with best medical treatment, including antiplatelet medications such as Aspirin combined with Clopidogrel or Ticagrelor before surgery. Those assigned to CEA will continue with single antiplatelet therapy after surgery, while those assigned to CAS will continue dual antiplatelet therapy for three months before switching to single therapy. One group will have the procedure within 48 hours after randomization, and the other group will have it 14 days later.
During the study, participants will be closely monitored for strokes, heart attacks, deaths, and urgent revascularizations from randomization up to three months. Evaluations will include brain imaging, functional and health quality assessments, and recording hospital stays and costs. The study will also track adverse events and recovery progress to understand the best timing for surgical treatment in this patient group.
CONDITIONS
Brief Title
Carotid Endarterectomy and Stenting Timing
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
Age 18 years or older
Diagnosed with symptomatic carotid stenosis with sudden neurological symptoms within 180 days before randomization
Stenosis located in the extracranial internal carotid artery
Degree of stenosis 50% to 99% confirmed by imaging using NASCET criteria
Brain MRI within 72 hours before randomization showing acute infarction in the affected vascular territory
Modified Rankin Scale (mRS) score less than 3
Provided written informed consent
You will not qualify if you...
Progressive neurological worsening within 72 hours before randomization
Brain MRI showing large infarction more than half of the middle cerebral artery territory
MRI evidence of hemorrhagic or other non-ischemic cerebrovascular diseases
Non-atherosclerotic carotid stenosis conditions like artery dissection or fibromuscular dysplasia
Need for additional surgery on other vascular lesions
History of cerebrovascular surgery within 6 months
Coexisting cerebrovascular stenosis requiring revascularization within 3 months
History of spontaneous intracranial hemorrhage within 12 months
Clear indication for anticoagulation therapy
Laboratory abnormalities affecting blood counts or clotting
Inability to use antiplatelet therapy due to medical conditions
Severe diseases affecting study adherence
Pregnant or breastfeeding women not in menopause
Participation in other interfering clinical trials
Any other medical condition affecting safety or study assessments
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - From randomization to 3 months
Participants undergo carotid endarterectomy (CEA) or carotid artery stenting (CAS) combined with best medical treatment. Surgery timing varies by group: either within 48 hours after randomization or after 14 days. Medical treatment includes antiplatelet therapy before and after surgery depending on the assigned procedure.
1 surgery visit plus follow-up visits during 3 months post-randomization
Editor's Choice - European Society for Vascular Surgery (ESVS) 2023 Clinical Practice Guidelines on the Management of Atherosclerotic Carotid and Vertebral Artery Disease.