An interventional study of intermittent hypoxia intervention and Carotid Artery Stenting (CAS) in Internal Carotid Artery Stenosis, sponsored by Capital Medical University. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-09-25.
Sponsored by Capital Medical University · Not applicable, Interventional, and Prevention
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).
Study Objective：To explore the safety and efficacy of Intermittent Hypoxia Treatment (IHT) for the prevention of peri-operative embolism-induced microinfarcts in patients with severe internal carotid artery stenosis (ICAS) undergoing carotid artery stenting (CAS).Study Content：A proof-of-concept phase 2 randomized controlled trial will be conducted to analyze the safety and potential protective effects of IHT in patients with ICAS receiving stent implantation. Intermittent hypoxia treatment will be administered pre-operatively and post-operatively, and differences including the incidence of postoperative microinfarcts will be compared between the two groups.
364 studies on the registry are indexed under Carotid Stenosis; 85 are open to participants now.
This study's planned enrollment of 176 is above the median of 103 across 189 interventional studies indexed under Carotid Stenosis.
Browse Carotid Stenosis studies →Capital Medical University is the lead sponsor of 295 studies on the registry; 91 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients receive intermittent hypoxia therapy plus standard carotid artery stenting. Brain MRI, blood sampling and other examinations are performed upon completion of treatment and within 48 hours post-surgery.
Procedure: intermittent hypoxia intervention · Procedure: Carotid Artery Stenting (CAS) · Other: Standard Medical Therapy
Patients receive standard-of-care carotid artery stenting without additional interventions
Procedure: Carotid Artery Stenting (CAS) · Other: Standard Medical Therapy
Patients 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.
Patients receive standard carotid artery stenting.
Patients 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).
Time frame: Within 48 hours after carotid artery stenting
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.
Time frame: 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.
Time frame: 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.
Time frame: Within 72 hours after surgery
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.
Time frame: From baseline to within 72 hours after CAS
Incidence of Restenosis Assessed by Computed Tomographic Angiography (CTA) Within 72 Hours After CAS
Proportion of participants with restenosis assessed by computed tomographic angiography (CTA) within 72 hours after CAS.
Time frame: Within 72 hours after CAS
Number of New Cerebral Lesions on DWI Within 48 Hours After CAS
Number of new cerebral lesions detected on brain diffusion-weighted imaging (DWI) within 48 hours after CAS.
Time frame: Within 48 hours after CAS
Incidence of acute myocardial infarction within 1 month after CAS.
Proportion of participants with acute myocardial infarction within 1 month after CAS
Time frame: within 1 month after CAS
Incidence of All-Cause Death Within 1 Month After CAS
Proportion of participants who died from any cause within 1 month after CAS.
Time frame: within 1 month after CAS
Volume of New Cerebral Lesions on DWI Within 48 Hours After CAS
Volume of new cerebral lesions detected on brain diffusion-weighted imaging (DWI) within 48 hours after CAS, measured in mm³.
Time frame: Within 48 hours after CAS.
Change in Heart Rate Variability (HRV) Within 72 Hours After CAS
Change in heart rate variability (HRV) within 72 hours after CAS.
Time frame: Within 72 hours after CAS.
Change in Blood Pressure (BP) Within 72 Hours After CAS
Change in blood pressure (BP) within 72 hours after CAS.
Time frame: Within 72 hours after CAS.
Change in Intracranial Pressure (ICP) Within 72 Hours After CAS
Change in intracranial pressure (ICP) within 72 hours after CAS.
Time frame: Within 72 hours after CAS.
Change in Cerebral Perfusion Pressure (CPP) Within 72 Hours After CAS
Change in cerebral perfusion pressure (CPP) within 72 hours after CAS.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: During each IHT session and within 30 minutes after each IHT session.
Heart Rate (HR) During and After Intermittent Hypoxia Treatment (IHT)
Heart rate (HR) measured during each IHT session and within 30 minutes after each IHT session.
Time frame: During each IHT session and within 30 minutes after each IHT session.
Respiratory Rate (RR) During and After Intermittent Hypoxia Treatment (IHT)
Respiratory rate (RR) measured during each IHT session and within 30 minutes after each IHT session.
Time frame: During each IHT session and within 30 minutes after each IHT session.
Cerebral Oxygen Saturation (rSO₂) During and After Intermittent Hypoxia Treatment (IHT)
Cerebral oxygen saturation (rSO₂) measured during each IHT session and within 30 minutes after each IHT session.
Time frame: During each IHT session and within 30 minutes after each IHT session.
Incidence of Other Adverse Events During and Following IHT
Proportion of participants with other adverse events during each IHT session and within 24 hours after each IHT session, including intolerable discomfort and symptoms that seriously affect normal life and work, such as palpitations, shortness of breath, and dyspnea.
Time frame: During each IHT session and within 24 hours after each IHT session.
Plan to share: No
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