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.
Study Type
OBSERVATIONAL
Enrollment
150
Surgeons follow the contemporary guideline combined with their experience and preference in order to ultimately select what is best suited for the patient and choose between CEA and CAS. Patients will receive 100 mg of aspirin or 75 mg of clopidogrel daily starting from at least 72 h prior to the CEA procedure and continued receiving the medication indefinitely. General anesthesia is recommended for CEA, although the use of standard or eversion endarterectomy, and a shunt or patch, is left to the discretion of the surgeon.
Surgeons follow the contemporary guideline combined with their experience and preference in order to ultimately select what is best suited for the patient and choose between CEA and CAS. Patients will be given 100 mg of aspirin plus 75 mg of clopidogrel daily for at least 3 days before the CAS procedure and for 90 days after the procedure. They will receive a daily dose of 100 mg aspirin or 75 mg clopidogrel thereafter. For the CAS procedure, local anaesthesia and predilation prior to stent placement are recommended. Use of an embolic protection device is mandatory for all patients who undergo CAS.
Xuanwu Hospital, Capital Medical University
Beijing, Beijing Municipality, China
RECRUITINGGuangdong Provincial People's Hospital
Guangzhou, Guangdong, China
RECRUITINGStroke or death within 1 month
A composite of any stroke or death occurring within 1-month post-procedure.
Time frame: Within 1-month post-procedure
Stroke beyond 1 month within 1 year
Stroke beyond 1 month within 1 year
Time frame: Beyond 1-month and within 1 year post-procedure
Death beyond 1 month within 1 year
Death beyond 1 month within 1 year
Time frame: Beyond 1-month and within 1 year post-procedure
Stroke or death within 1 year
Stroke or death within 1 year
Time frame: Within 1 year post-procedure
Cranial nerve injury
Number of participants who suffered from cranial nerve injury
Time frame: Within 1-month post-procedure
Carotid artery restenosis
Number of participants who suffered from carotid artery restenosis (\> 50%) detected by ultrasonography, CTA, or DSA
Time frame: Within 1-year post-procedure
Functional outcome
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)
Time frame: Within 1-year post-procedure
Other major complications
Other major complications, such as myocardial infarction, incision hematoma, pulmonary infection, etc.
Time frame: Within 1-month post-procedure
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