Carotid artery surgery for patients with radiation-induced stenosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the outcomes of carotid endarterectomy (CEA) in patients who have developed carotid artery stenosis due to prior cervical radiotherapy for head and neck cancer. It aims to assess both the short-term safety and long-term efficacy of CEA compared to carotid artery stenting (CAS) in a Chinese population. The study will involve a prospective registry of patients with confirmed carotid stenosis, ensuring that the stenosis developed at least one year after radiation therapy. The findings will help clarify the best surgical approach for these patients.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patients with carotid stenosis who had a history of radiotherapy for head and neck cancer. (The median interval between the completion of radiation therapy and development of carotid artery stenosis detected on imaging (or vascular intervention) was no less than 1 years to avoid non-related situations. The target area of the radiotherapy included at least the ipsilateral neck, including part of the carotid system. The internal carotid stenosis was confirmed by angiography, Duplex, 3D angio-CTA or angio-MRI, and stenosis was defined as \> 50% based on North American Symptomatic Carotid Endarterectomy Trial criteria), with or without symptom. Patients with a transient ischaemic attack (TIA) or stroke within 6 months were defined as symptomatic. TIA was defined as a transient episode of neurological dysfunction (focal weakness/ language disturbance/transient monocular blindness/ requiring assistance to walk) caused by focal brain or retinal ischemia that lasts for at least 10 min but resolves within 24 h.)

Exclusion Criteria:

* The patients treated for restenosis.
* Intracranial arteriovenous malformation or aneurysm
* Severe stenosis or occlusion of the ipsilateral intracranial artery
* Unstable angina, myocardial infarction (MI), or congestive heart failure in the last 6 months
* Uncorrectable coagulation abnormalities
* Uncontrolled diabetes mellitus defined as glucose \> 300 mg/dL (16.67 mmol/L)
* Pregnant or in the perinatal period
* Severe concomitant disease with poor prognosis (life expectancy \< 2 years)
* Intolerance or allergies to any of the study medications, such as aspirin or clopidogrel

Where it's running

• Xuanwu Hospital, Capital Medical University
  Beijing, Beijing Municipality, China Recruiting
• Guangdong Provincial People's Hospital
  Guangzhou, Guangdong, China Recruiting

Study contacts

• Principal investigator: Tao Wang, MD — Xuanwu Hospital, Beijing
• Study coordinator: Tao Wang, MD
• Email: wangtao_dr@sina.com
• Phone: 18810302298

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.