Internal Carotid Artery StenosisNCT07837011
Safety and Efficacy of Carotid Artery Stenting Combined With Intermittent Hypoxia Intervention in Patients With Severe Internal Carotid Artery Stenosis
A study testing intermittent hypoxia intervention, Carotid Artery Stenting (CAS) and Standard Medical Therapy in people with Internal Carotid Artery Stenosis, run by Capital Medical University at 1 site in China.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Internal Carotid Artery Stenosis
- What is being tested?
- intermittent hypoxia intervention, Carotid Artery Stenting (CAS) and Standard Medical Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 176 participants
- Where
- 1 siteChina
- Study dates
- 20 Sep 2026to 30 Sep 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- For female subjects of child-bearing potential, a negative pregnancy test shall be confirmed prior to enrollment.
- Stable vital signs with no significant abnormalities in liver and renal function tests.
- Fully informed of the study content before trial participation and voluntarily providing written informed consent.
Who cannot join
- 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).
- Severe arrhythmia or chronic atrial fibrillation.
- Pulmonary disease (Chronic Obstructive Pulmonary Disease，COPD), respiratory insufficiency, or requirement for oxygen supplementation.
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- Uncontrolled hypertension (systolic blood pressure ≥200 mmHg despite pharmacotherapy at enrollment).
- Concurrent participation in another device or drug clinical trial.
- Any condition that prevents angiographic assessment or renders percutaneous arterial puncture unsafe.
- High-risk patients as defined by the Carotid Revascularization Endarterectomy vs. Stenting Trial (CREST).
- Near-occlusion (90-99%) or occlusion of unilateral internal carotid artery (ICA) shown on carotid ultrasound, CTA or MRA (per NASCET criteria).
- Other contraindications to intermittent hypoxia treatment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Zhao Wenbo contact
China1 site
Oxygen Concentrator；Oxygen Mask
Beijing, Beijing Municipality, 100053
Ji Xunming, 01083198962, jixm@ccmu.edu.cn
About this study
Official title: 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
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).
Read the detailed description
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.
- Conditions
- Internal Carotid Artery Stenosis
- Being tested
- intermittent hypoxia intervention, Carotid Artery Stenting (CAS), Standard Medical Therapy
- Keywords
- Intermittent Hypoxia Intervention, Carotid Artery Stenting, microinfarcts, Internal Carotid Artery Stenosis
- Medical subject headings
- Carotid Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intermittent hypoxia interventionProcedure or surgery
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.
Carotid Artery Stenting (CAS)Procedure or surgery
Patients receive standard carotid artery stenting.
Standard Medical TherapyOther
Patients receive standard medical therapy including antiplatelet agents, statins, and risk factor control (blood pressure, HbA1c, LDL).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: intermittent hypoxia intervention; Procedure: Carotid Artery Stenting (CAS); Other: Standard Medical Therapy |
| Carotid Artery Stenting only | Active comparator | Patients receive standard-of-care carotid artery stenting without additional interventions Receives: Procedure: Carotid Artery Stenting (CAS); Other: Standard Medical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of ≥1 new cerebral lesion detected on brain diffusion-weighted imaging (DWI) within 48 hours after carotid artery stenting (CAS).
Measured: Within 48 hours after carotid artery stenting
Secondary outcomes (13)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Within 72 hours after CAS.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2026
- Study start20 Sep 2026 (estimated)
- Primary completion30 Sep 2028 (estimated)
- Study completion30 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Internal Carotid Artery StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 176 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ji Xunming,MD,PhD, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07837011
- Sponsor's protocol ID
- SESCIPS
- Status last verified
- Sep 2026
- First submitted
- 10 Sep 2026
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No