Endarterectomy for symptomatic carotid stenosis in relation to clinical subgroups and timing of surgery.
P M Rothwell, M Eliasziw, S A Gutnikov...
https://pubmed.ncbi.nlm.nih.gov/15043958/Actively Recruiting
Led by Xuanwu Hospital, Beijing · Updated on 2025-08-15
268
Participants Needed
1
Research Sites
26 weeks
Total Duration
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
Carotid Endarterectomy and Stenting Timing
Y
Yan Prof. Ma, MD
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Xuanwu Hospital, Beijing
Lead Sponsor
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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P M Rothwell, M Eliasziw, S A Gutnikov...
https://pubmed.ncbi.nlm.nih.gov/15043958/Ross Naylor, Barbara Rantner, Stefano Ancetti...
https://pubmed.ncbi.nlm.nih.gov/35598721/Xuanwu Hospital, Beijing
Lead Sponsor