Remote Ischemic Conditioning Plus Stenting for Symptomatic Carotid Artery Stenosis

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40+
SponsorGeneral Hospital of Shenyang Military Region

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Remote ischemic conditioning

    Device

    The 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

300 Participants
are divided into 2 treatment groups
Group A: RIC groupExperimental treatment 1 intervention
Group B: Control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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

Time frame
1 year

Secondary outcomes

1

composite of periprocedural death, stroke, or myocardial infarction

Time frame
30±3 days
2

occurence of non-fatal stroke and TIA

Time frame
1 year
3

occurence of nonfatal myocardial infarction

Time frame
1 year
4

numbers of new silent cerebral infarcts on Magnetic Resonance Imaging

Time frame
1 year

Other outcomes

Sponsors and contacts

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