Clinical trial NCT05134246: Carotid Revascularization for Radiation Induced Carotid Artery Stenosis
Official title: Outcomes of Carotid Revascularization for Patients With Radiation Induced Carotid Artery Stenosis in China
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Radiation-induced Carotid Artery Stenosis
Keywords: Radiation-induced carotid artery stenosis
Carotid endarterectomy
Outcomes
Lead sponsor: Xuanwu Hospital, Beijing
Sponsor class: OTHER
Collaborators: name: Guangdong Provincial People's Hospital
First posted: 2021-11-24
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with RICS and fulfilled the above eligible criteria in tertiary medical centers in China, will be enrolled consecutively.

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

Primary outcomes:
measure: Stroke or death within 1 month
timeFrame: Within 1-month post-procedure
Secondary outcomes:
measure: Stroke beyond 1 month within 1 year
timeFrame: Beyond 1-month and within 1 year post-procedure
measure: Death beyond 1 month within 1 year
timeFrame: Beyond 1-month and within 1 year post-procedure
measure: Stroke or death within 1 year
timeFrame: Within 1 year post-procedure
measure: Cranial nerve injury
timeFrame: Within 1-month post-procedure
measure: Carotid artery restenosis
timeFrame: Within 1-year post-procedure
measure: Functional outcome
timeFrame: Within 1-year post-procedure
measure: Other major complications
timeFrame: Within 1-month post-procedure
Other outcomes:
Locations:
city: Beijing
country: China
facility: Xuanwu Hospital, Capital Medical University
state: Beijing
city: Guangzhou
country: China
facility: Guangdong Provincial People's Hospital
state: Guangdong
Study officials:
affiliation: Xuanwu Hospital, Beijing
name: Liqun Jiao, MD
role: STUDY_CHAIR
affiliation: Xuanwu Hospital, Beijing
name: Tao Wang, MD
role: PRINCIPAL_INVESTIGATOR
References: