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Safety and Efficacy of Carotid Artery Stenting Combined With Intermittent Hypoxia Intervention in Patients With Severe Internal Carotid Artery Stenosis
Sponsor: Capital Medical University
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).
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
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
176
Start Date
2026-09-20
Completion Date
2028-09-30
Last Updated
2026-09-25
Healthy Volunteers
No
Conditions
Interventions
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.
Carotid Artery Stenting (CAS)
Patients receive standard carotid artery stenting.
Standard Medical Therapy
Patients receive standard medical therapy including antiplatelet agents, statins, and risk factor control (blood pressure, HbA1c, LDL).
Locations (1)
Oxygen Concentrator;Oxygen Mask
Beijing, Beijing Municipality, China