Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06898151

Carotid Endarterectomy and Stenting Timing

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

268

Participants Needed

1

Research Sites

129 weeks

Total Duration

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AI-Summary

What this Trial Is About

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.

CONDITIONS

Official 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, possibly involving the adjacent common carotid artery
  • Degree of stenosis between 50% and 99% confirmed by CTA, MRA, or DSA based on NASCET criteria
  • Brain MRI within 72 hours before randomization showing acute infarction in the responsible vascular territory by DWI and ADC
  • Modified Rankin Scale score less than 3
  • Written informed consent obtained from patient or legal representative
Not Eligible

You will not qualify if you...

  • Progressive neurological worsening within 72 hours before randomization, with increased mRS by 2 points or NIHSS by 4 points
  • Brain MRI within 72 hours before randomization showing large infarction greater than half of the middle cerebral artery territory
  • MRI evidence of hemorrhagic or non-ischemic cerebrovascular diseases
  • Non-atherosclerotic carotid stenosis causes such as dissection, carotid web, thrombus, fibromuscular dysplasia, Takayasu arteritis
  • Need for simultaneous surgery for tandem lesions 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 need for anticoagulation therapy due to cardiac embolic sources
  • Laboratory abnormalities including low white blood cells, low hematocrit, low platelets, elevated INR, or heparin-induced thrombocytopenia
  • Inability to use antiplatelet therapy due to gastrointestinal ulcers, bleeding, allergy, severe kidney or liver problems, or severe heart failure
  • Presence of severe diseases affecting study adherence such as severe infection, advanced COPD, active cancer, dementia, psychiatric disorders, or uncontrolled severe hypertension
  • Pregnant or breastfeeding women who are not menopausal
  • Participation in another investigational trial that may interfere
  • Any other medical condition or history that may affect safety or efficacy assessments

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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

CONTACT

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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