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NOT YET RECRUITING
NCT07837011
NA

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

Sponsor: Capital Medical University

View on ClinicalTrials.gov

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

Interventions

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.

PROCEDURE

Carotid Artery Stenting (CAS)

Patients receive standard carotid artery stenting.

OTHER

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