Carotid Revascularization for Radiation Induced Carotid Artery Stenosis
- Conditions
- Radiation-induced Carotid Artery Stenosis
- Interventions
- Procedure: Carotid artery stenting (CAS)Procedure: Carotid endarterectomy (CEA)
- Registration Number
- NCT05134246
- Lead Sponsor
- Xuanwu Hospital, Beijing
- Brief Summary
Cervical radiotherapy (RT) has greatly reduced the mortality of patients with malignant head and neck tumors, which, however, causes a higher risk of carotid artery stenosis, namely, radiation-induced carotid artery stenosis (RICS) and results in a significant increased risk of ischemic stroke. The systematic review and meta-analysis conducted by our team showed carotid endarterectomy (CEA) can yield better results for these patients than carotid artery stenting (CAS), which was contrary to most previous clinical guidelines. A large-scale prospective study is needed to verify the results. We will conduct a prospective registry of RICS patients treated with CEA to evaluate both short-term safety and long-term efficacy outcomes in a Chinese population.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 150
- 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.)
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Carotid artery stenting (CAS) Carotid artery stenting (CAS) Patients who are treated with CAS. Carotid endarterectomy (CEA) Carotid endarterectomy (CEA) Patients who are treated with CEA.
- Primary Outcome Measures
Name Time Method Stroke or death within 1 month Within 1-month post-procedure A composite of any stroke or death occurring within 1-month post-procedure.
- Secondary Outcome Measures
Name Time Method Stroke beyond 1 month within 1 year Beyond 1-month and within 1 year post-procedure Stroke beyond 1 month within 1 year
Death beyond 1 month within 1 year Beyond 1-month and within 1 year post-procedure Death beyond 1 month within 1 year
Stroke or death within 1 year Within 1 year post-procedure Stroke or death within 1 year
Cranial nerve injury Within 1-month post-procedure Number of participants who suffered from cranial nerve injury
Carotid artery restenosis Within 1-year post-procedure Number of participants who suffered from carotid artery restenosis (\> 50%) detected by ultrasonography, CTA, or DSA
Functional outcome Within 1-year post-procedure Functional outcome indicated by NIHSS (National Institutes of Health Stroke Scale: 0-42; higher scores indicate worse outcome) or mRS (modified Rankin Scale: 0-6; higher scores indicate worse outcome)
Other major complications Within 1-month post-procedure Other major complications, such as myocardial infarction, incision hematoma, pulmonary infection, etc.
Trial Locations
- Locations (2)
Guangdong Provincial People's Hospital
🇨🇳Guangzhou, Guangdong, China
Xuanwu Hospital, Capital Medical University
🇨🇳Beijing, Beijing, China