NCT05134246 Carotid Revascularization for Radiation Induced Carotid Artery Stenosis
| NCT ID | NCT05134246 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Xuanwu Hospital, Beijing |
| Condition | Radiation-induced Carotid Artery Stenosis |
| Study Type | OBSERVATIONAL |
| Enrollment | 150 participants |
| Start Date | 2020-01-05 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 150 participants in total. It began in 2020-01-05 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Liqun Jiao, MD
STUDY CHAIR
Xuanwu Hospital, Beijing
Frequently Asked Questions
Who can join the NCT05134246 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Radiation-induced Carotid Artery Stenosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05134246 currently recruiting?
Yes, NCT05134246 is actively recruiting participants. Contact the research team at wangtao_dr@sina.com for enrollment information.
Where is the NCT05134246 trial being conducted?
This trial is being conducted at Beijing, China, Guangzhou, China.
Who is sponsoring the NCT05134246 clinical trial?
NCT05134246 is sponsored by Xuanwu Hospital, Beijing. The principal investigator is Liqun Jiao, MD at Xuanwu Hospital, Beijing. The trial plans to enroll 150 participants.