Carotid artery surgery for patients with radiation-induced stenosis

Outcomes of Carotid Revascularization for Patients With Radiation Induced Carotid Artery Stenosis in China

This study is testing whether carotid artery surgery is safer and more effective than stenting for patients who have narrow arteries from previous radiation treatment for head and neck cancer.

Quick facts

• Study type: Observational
• Enrollment: 150 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Xuanwu Hospital, Beijing (other)
• Drugs / interventions: radiation
• Locations: 2 sites (Beijing, Beijing Municipality and 1 other locations)
• Trial ID: NCT05134246 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include patients with carotid stenosis who have a history of radiotherapy for head and neck cancer and meet specific imaging criteria.

Not a fit: Patients who have not undergone radiotherapy for head and neck cancer or those with carotid stenosis unrelated to radiation exposure may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide evidence supporting CEA as a safer and more effective treatment for patients with radiation-induced carotid artery stenosis.

How similar studies have performed: Previous studies have indicated that CEA may yield better outcomes than CAS for similar conditions, suggesting a promising approach in this context.

Eligibility criteria

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 this trial is running

Beijing, Beijing Municipality and 1 other locations

• 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

Conditions: Radiation-induced Carotid Artery Stenosis, Radiation-induced carotid artery stenosis, Carotid endarterectomy, Outcomes