[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657300":3},{"organization":4,"outcomesModule":7,"designInfo":87,"detailedDescription":95,"studyPopulation":11,"armGroups":96,"interventions":110,"overallOfficials":11,"centralContacts":124,"locations":132,"responsibleParty":148,"collaborators":11,"id":152,"slug":153,"hasResults":154,"nctId":155,"briefTitle":156,"officialTitle":157,"acronym":11,"eligibilityCriteria":158,"healthyVolunteers":154,"sex":159,"minAge":160,"maxAge":161,"enrollmentInfo":162,"targetDuration":11,"studyType":165,"phases":166,"briefSummary":168,"conditions":169,"keywords":171,"overallStatus":175,"whyStopped":11,"lastUpdateSubmitDate":176,"lastUpdatePostDateStruct":177,"startDateStruct":180,"completionDateStruct":182,"leadSponsor":184,"locationsCount":185},{"fullName":5,"class":6},"Capital Medical University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":60},[9],{"measure":10,"description":11,"timeFrame":12},"Incidence of ≥1 new cerebral lesion detected on brain diffusion-weighted imaging (DWI) within 48 hours after carotid artery stenting (CAS).",null,"Within 48 hours after carotid artery stenting",[14,18,21,25,29,33,36,40,43,47,51,54,57],{"measure":15,"description":16,"timeFrame":17},"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.","Within 1 month after CAS",{"measure":19,"description":19,"timeFrame":20},"Number and volume of new cerebral lesions within 48 hours after CAS.","Within 48 hours after CAS",{"measure":22,"description":23,"timeFrame":24},"Change in Heart Rate (HR) Within 72 Hours After CAS","Change in heart rate (HR) within 72 hours after CAS.","Within 72 hours after surgery",{"measure":26,"description":27,"timeFrame":28},"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.","From baseline to within 72 hours after CAS",{"measure":30,"description":31,"timeFrame":32},"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.","Within 72 hours after CAS",{"measure":34,"description":35,"timeFrame":20},"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.",{"measure":37,"description":38,"timeFrame":39},"Incidence of acute myocardial infarction within 1 month after CAS.","Proportion of participants with acute myocardial infarction within 1 month after CAS","within 1 month after CAS",{"measure":41,"description":42,"timeFrame":39},"Incidence of All-Cause Death Within 1 Month After CAS","Proportion of participants who died from any cause within 1 month after CAS.",{"measure":44,"description":45,"timeFrame":46},"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.","Within 48 hours after CAS.",{"measure":48,"description":49,"timeFrame":50},"Change in Heart Rate Variability (HRV) Within 72 Hours After CAS","Change in heart rate variability (HRV) within 72 hours after CAS.","Within 72 hours after CAS.",{"measure":52,"description":53,"timeFrame":50},"Change in Blood Pressure (BP) Within 72 Hours After CAS","Change in blood pressure (BP) within 72 hours after CAS.",{"measure":55,"description":56,"timeFrame":50},"Change in Intracranial Pressure (ICP) Within 72 Hours After CAS","Change in intracranial pressure (ICP) within 72 hours after CAS.",{"measure":58,"description":59,"timeFrame":50},"Change in Cerebral Perfusion Pressure (CPP) Within 72 Hours After CAS","Change in cerebral perfusion pressure (CPP) within 72 hours after CAS.",[61,65,69,72,75,78,81,84],{"measure":62,"description":63,"timeFrame":64},"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.","During each IHT session and within 30 minutes after each IHT session.",{"measure":66,"description":67,"timeFrame":68},"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.","During each IHT session and within 24 hours after each IHT session.",{"measure":70,"description":71,"timeFrame":64},"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.",{"measure":73,"description":74,"timeFrame":64},"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.",{"measure":76,"description":77,"timeFrame":64},"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.",{"measure":79,"description":80,"timeFrame":64},"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.",{"measure":82,"description":83,"timeFrame":64},"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.",{"measure":85,"description":86,"timeFrame":68},"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.",{"allocation":88,"interventionModel":89,"interventionModelDescription":11,"primaryPurpose":90,"observationalModel":11,"timePerspective":11,"maskingInfo":91},"RANDOMIZED","PARALLEL","PREVENTION",{"masking":92,"maskingDescription":11,"whoMasked":93},"SINGLE",[94],"OUTCOMES_ASSESSOR","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.",[97,105],{"label":98,"type":99,"description":100,"interventionNames":101},"Carotid Artery Stenting Combined with Intermittent Hypoxia Intervention","EXPERIMENTAL","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.",[102,103,104],"Procedure: intermittent hypoxia intervention","Procedure: Carotid Artery Stenting (CAS)","Other: Standard Medical Therapy",{"label":106,"type":107,"description":108,"interventionNames":109},"Carotid Artery Stenting only","ACTIVE_COMPARATOR","Patients receive standard-of-care carotid artery stenting without additional interventions",[103,104],[111,116,120],{"type":112,"name":113,"description":114,"armGroupLabels":115,"otherNames":11},"PROCEDURE","intermittent hypoxia intervention","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.",[98],{"type":112,"name":117,"description":118,"armGroupLabels":119,"otherNames":11},"Carotid Artery Stenting (CAS)","Patients receive standard carotid artery stenting.",[98,106],{"type":6,"name":121,"description":122,"armGroupLabels":123,"otherNames":11},"Standard Medical Therapy","Patients receive standard medical therapy including antiplatelet agents, statins, and risk factor control (blood pressure, HbA1c, LDL).",[98,106],[125,130],{"name":126,"role":127,"phone":128,"phoneExt":11,"email":129},"Ji Xunming","CONTACT","01083198962","jixm@ccmu.edu.cn",{"name":131,"role":127,"phone":11,"phoneExt":11,"email":11},"Zhao Wenbo",[133],{"facility":134,"status":11,"city":135,"state":136,"zip":137,"country":138,"countryCode":139,"cosmosGeoPoint":140,"geoPoint":145,"contacts":146},"Oxygen Concentrator；Oxygen Mask","Beijing","Beijing Municipality","100053","China","CN",{"type":141,"coordinates":142},"Point",[143,144],116.39723,39.9075,{"lat":144,"lon":143},[147],{"name":126,"role":127,"phone":128,"phoneExt":11,"email":129},{"type":149,"investigatorFullName":150,"investigatorTitle":151,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"PRINCIPAL_INVESTIGATOR","Ji Xunming,MD,PhD","Professor of Neurology, Xuanwu Hospital, Capital Medical University","100657300","safety-and-efficacy-of-carotid-artery-stenting-combined-with-intermittent-hypoxia-intervention-in-patients-with-severe-internal-carotid-artery-stenosis-100657300",false,"NCT07837011","Safety and Efficacy of Carotid Artery Stenting Combined With Intermittent Hypoxia Intervention in Patients With Severe Internal Carotid Artery Stenosis","Safety and Efficacy of Carotid Artery Stenting Combined With Intermittent Hypoxia Intervention in Patients With Severe Internal Carotid Artery Stenosis: A Proof-of-Concept Randomized Controlled Trial","Inclusion Criteria:\n\n1. Aged 18-70 years, BMI 18.5-24 kg\u002Fm², of any gender; treated in the Department of Neurology or Neurosurgery of our hospital and scheduled for carotid artery stenting.\n2. 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).\n3. No history of relevant drug allergy; tolerable to clopidogrel, aspirin and statins.\n4. Good compliance, capable of cooperating with and completing brain MRI examinations.\n5. For female subjects of child-bearing potential, a negative pregnancy test shall be confirmed prior to enrollment.\n6. Stable vital signs with no significant abnormalities in liver and renal function tests.\n7. Fully informed of the study content before trial participation and voluntarily providing written informed consent.\n\nExclusion Criteria:\n\n1. Progressive stroke.\n2. Prior ipsilateral stroke with residual neurological deficits.\n3. Severe dementia at enrollment.\n4. Uncorrected severe cardiovascular diseases (e.g., myocardial infarction within 30 days prior to enrollment, severe heart failure).\n5. Severe arrhythmia or chronic atrial fibrillation.\n6. Pulmonary disease (Chronic Obstructive Pulmonary Disease，COPD), respiratory insufficiency, or requirement for oxygen supplementation.\n7. Uncontrolled hypertension (systolic blood pressure ≥200 mmHg despite pharmacotherapy at enrollment).\n8. Concurrent participation in another device or drug clinical trial.\n9. Any condition that prevents angiographic assessment or renders percutaneous arterial puncture unsafe.\n10. High-risk patients as defined by the Carotid Revascularization Endarterectomy vs. Stenting Trial (CREST).\n11. Near-occlusion (90-99%) or occlusion of unilateral internal carotid artery (ICA) shown on carotid ultrasound, CTA or MRA (per NASCET criteria).\n12. Other contraindications to intermittent hypoxia treatment.","ALL","18 Years","70 Years",{"count":163,"type":164},176,"ESTIMATED","INTERVENTIONAL",[167],"NA","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).",[170],"Internal Carotid Artery Stenosis",[172,173,174,170],"Intermittent Hypoxia Intervention","Carotid Artery Stenting","microinfarcts","NOT_YET_RECRUITING","2026-09-23",{"date":178,"type":179},"2026-09-25","ACTUAL",{"date":181,"type":164},"2026-09-20",{"date":183,"type":164},"2028-09-30",{"name":5,"class":6},1]