About this trial
Remote ischemic conditioning (RIC) has emerged as a promising non-invasive strategy to protect the brain, with evidence suggesting its benefit in patients with carotid artery stenting (CAS). However, the long-term benefit and safety of chronic RIC in this population remain unknown. This trial aims to evaluate whether chronic RIC reduces the incidence of major vascular events and improves clinical outcomes in high-risk patients with carotid artery stenosis who received CAS.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 40 years old;
Patients with symptomatic moderate to severe stenosis of the internal carotid artery;
History of ipsilateral cerebral ischemic symptoms within the past 180 days;
Planned for carotid artery stent;
Disqualifiers
Uncontrolled severe hypertension (systolic blood pressure > 180 mmHg or diastolic blood pressure > 110 mmHg despite medication)
Subclavian artery stenosis ≥ 50% or presence of subclavian steal syndrome
Severe hematological disorders or significant coagulation abnormalities
Contraindications to remote ischemic conditioning, such as severe soft tissue injury, fracture, or vascular injury in the upper limbs, or peripheral vascular disease in the distal upper limbs
Trial design
Parallel
Treatments tested in this trial
Remote ischemic conditioning
DeviceThe RIC protocol involves bilateral upper-arm cuff inflation to 200 mmHg (5-min inflation/5-min deflation, 5 cycles) performed 1-2 times daily, starting 3 days before CAS and continuing for 12 months post-procedure.
Treatment groups
Trial outcomes
Primary outcomes
time to the first occurrence of any component of the composite endpoint within 12 months post-randomization
the composite endpoint includes ischemic stroke, hemorrhagic stroke, myocardial infarction \[including coronary revascularization\], TIA, or vascular death
Secondary outcomes
composite of periprocedural death, stroke, or myocardial infarction
occurence of non-fatal stroke and TIA
occurence of nonfatal myocardial infarction
numbers of new silent cerebral infarcts on Magnetic Resonance Imaging
Sponsors and contacts
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