Safety and Efficacy of Carotid Artery Stenting Combined With Intermittent Hypoxia Intervention in Patients With Severe Internal Carotid Artery Stenosis

NCT07837011 | Not Yet Recruiting DMC

• 1 other identifier: SESCIPS
• Study Type: interventional
• Target: 176
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Internal Carotid Artery Stenosis

Keywords

Intermittent Hypoxia Intervention; Carotid Artery Stenting; microinfarcts; Internal Carotid Artery Stenosis

Outcome Measures

Primary Outcomes (1)

• Incidence of ≥1 new cerebral lesion detected on brain diffusion-weighted imaging (DWI) within 48 hours after carotid artery stenting (CAS).

  Within 48 hours after carotid artery stenting

Secondary Outcomes (13)

• Incidence of acute cerebrovascular event within 1 month after CAS

  Within 1 month after CAS

• Number and volume of new cerebral lesions within 48 hours after CAS.

  Within 48 hours after CAS

• Change in Heart Rate (HR) Within 72 Hours After CAS

  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

  From baseline to within 72 hours after CAS

• Incidence of Restenosis Assessed by Computed Tomographic Angiography (CTA) Within 72 Hours After CAS

  Within 72 hours after CAS

Other Outcomes (8)

• Pulse Oxygen Saturation (SpO₂) During and After Intermittent Hypoxia Treatment (IHT)

  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

  During each IHT session and within 24 hours after each IHT session.

• Systolic Blood Pressure (SBP) During and After Intermittent Hypoxia Treatment (IHT)

  During each IHT session and within 30 minutes after each IHT session.

Study Arms (2)

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.

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

Procedure: Carotid Artery Stenting (CAS); Other: Standard Medical Therapy

Interventions

Carotid Artery Stenting (CAS) PROCEDURE

Patients receive standard carotid artery stenting.

Carotid Artery Stenting Combined with Intermittent Hypoxia Intervention; Carotid Artery Stenting only

Standard Medical Therapy OTHER

Patients receive standard medical therapy including antiplatelet agents, statins, and risk factor control (blood pressure, HbA1c, LDL).

Carotid Artery Stenting Combined with Intermittent Hypoxia Intervention; Carotid Artery Stenting only

intermittent hypoxia intervention PROCEDURE

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 Combined with Intermittent Hypoxia Intervention

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Capital Medical University: lead

Study Sites (1)

Oxygen Concentrator；Oxygen Mask

Beijing, Beijing Municipality, 100053, China

Location

MeSH Terms

Conditions

Carotid Stenosis

Condition Hierarchy (Ancestors)

Carotid Artery Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Ji Xunming

CONTACT

01083198962; jixm@ccmu.edu.cn

Zhao Wenbo

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Neurology, Xuanwu Hospital, Capital Medical University

Study Record Dates

• First Submitted: September 10, 2026
• First Posted: September 23, 2026
• Study Start: September 20, 2026
• Primary Completion (Estimated): September 30, 2028
• Study Completion (Estimated): September 30, 2028
• Last Updated: September 25, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)