This study aims to explore the efficacy of Intermittent Hypoxia Treatment (IHT) in preventing peri-operative embolism-related microinfarcts among patients with severe internal carotid artery stenosis (ICAS) undergoing carotid artery stenting (CAS).
Aged 18-70 years, BMI 18.5-24 kg/m², of any gender; treated in the Department of Neurology or Neurosurgery of our hospital and scheduled for carotid artery stenting.
Severe stenosis to occlusion (70-99%) of unilateral internal carotid artery (ICA) demonstrated by carotid ultrasound, Computed Tomography Angiography or Magnetic Resonance Angiography (per NASCET criteria).
No history of relevant drug allergy; tolerable to clopidogrel, aspirin and statins.
Good compliance, capable of cooperating with and completing brain MRI examinations.
Progressive stroke.
Prior ipsilateral stroke with residual neurological deficits.
Severe dementia at enrollment.
Uncorrected severe cardiovascular diseases (e.g., myocardial infarction within 30 days prior to enrollment, severe heart failure).
Parallel
intermittent hypoxia intervention
Procedure/SurgeryPatients receive intermittent hypoxia therapy twice daily (interval \> 6 hours) for at least 4 sessions consecutively before carotid artery stenting, and at least 2 consecutive sessions after the procedure. Each treatment consists of 4 cycles: each cycle comprises a hypoxic phase with inhalation of 13% O₂ for 10 minutes, followed by a normoxic phase with inhalation of 21% O₂ for 5 minutes, yielding a total duration of 60 minutes.
Carotid Artery Stenting (CAS)
Procedure/SurgeryPatients receive standard carotid artery stenting.
Standard Medical Therapy
Other interventionPatients receive standard medical therapy including antiplatelet agents, statins, and risk factor control (blood pressure, HbA1c, LDL).
Incidence of ≥1 new cerebral lesion detected on brain diffusion-weighted imaging (DWI) within 48 hours after carotid artery stenting (CAS).
Incidence of acute cerebrovascular event within 1 month after CAS
Incidence of ischemic stroke, transient ischemic attack (TIA), hemorrhagic stroke and hyperperfusion syndrome within 1 month after CAS.
Number and volume of new cerebral lesions within 48 hours after CAS.
Number and volume of new cerebral lesions within 48 hours after CAS.
Change in Heart Rate (HR) Within 72 Hours After CAS
Change in heart rate (HR) within 72 hours after CAS.
Change in Peak Systolic Velocity (PSV) in Intracranial and Extracranial Arteries Measured by Ultrasound From Baseline to Within 72 Hours After CAS
Change in peak systolic velocity (PSV) in intracranial and extracranial arteries assessed by ultrasound from baseline to within 72 hours after CAS.
Pulse Oxygen Saturation (SpO₂) During and After Intermittent Hypoxia Treatment (IHT)
Pulse oxygen saturation (SpO₂) measured during each IHT session and within 30 minutes after each IHT session.
Incidence of Hypoxia-Related Adverse Events Assessed by Lake Louise Score (LLS) During and Following IHT
Proportion of participants with hypoxia-related adverse events assessed by the Lake Louise Score (LLS), including headache, gastrointestinal disturbance, fatigue, weakness, and dizziness, during each IHT session and within 24 hours after each IHT session.
Systolic Blood Pressure (SBP) During and After Intermittent Hypoxia Treatment (IHT)
Systolic blood pressure (SBP) measured during each IHT session and within 30 minutes after each IHT session.
Diastolic Blood Pressure (DBP) During and After Intermittent Hypoxia Treatment (IHT)
Diastolic blood pressure (DBP) measured during each IHT session and within 30 minutes after each IHT session.
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