Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06898151

Carotid Endarterectomy and Stenting Timing: The CEST Trial

Led by Xuanwu Hospital, Beijing · Updated on 2025-08-15

268

Participants Needed

1

Research Sites

26 weeks

Total Duration

On this page

AI-Summary

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

Eligible

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
Not Eligible

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

AI-Screening

AI-Powered Screening

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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

Trial Site Locations

Total: 1 location

1

Xuanwu Hospital, Capital Medical University.

Beijing, China

Actively Recruiting

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Research Team

Y

Yan Prof. Ma, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Editor's Choice - European Society for Vascular Surgery (ESVS) 2023 Clinical Practice Guidelines on the Management of Atherosclerotic Carotid and Vertebral Artery Disease.

Ross Naylor, Barbara Rantner, Stefano Ancetti...

https://pubmed.ncbi.nlm.nih.gov/35598721