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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.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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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
Are there results?
Not yet: the study is under way

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.
Show all 12Show fewer
  • 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.

Ji Xunming contact

01083198962

jixm@ccmu.edu.cn

Zhao Wenbo contact

China1 site

  • Oxygen Concentrator；Oxygen Mask

    Beijing, Beijing Municipality, 100053

    Ji Xunming, 01083198962, jixm@ccmu.edu.cn

Other trials in China

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.

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 groups in NCT07837011
Study groupRoleWhat they receive
Carotid Artery Stenting Combined with Intermittent Hypoxia InterventionExperimentalPatients 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 onlyActive comparatorPatients 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.

  1. 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)

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  1. First posted23 Sep 2026
  2. Study start20 Sep 2026 (estimated)
  3. Primary completion30 Sep 2028 (estimated)
  4. Study completion30 Sep 2028 (estimated)

Resources

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)
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

Questions about this trial

What is this clinical trial studying?

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.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ji Xunming (01083198962, jixm@ccmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07837011.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.

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