Remote Ischemic Conditioning Plus Stenting for Symptomatic Carotid Artery Stenosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Remote ischemic conditioning.
- Who it may be relevant to
- Registry conditions: Carotid Stenosis. Basic parameters: from 40 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Remote Ischemic Conditioning Plus Stenting for Symptomatic Carotid Artery Stenosis (RICSICAS): A Prospective, Randomized Controlled, Blind Endpoint, Single-Center Study
Overview
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.
Interventions
- Device Remote ischemic conditioning
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.
Primary outcome measures
- time to the first occurrence of any component of the composite endpoint within 12 months post-randomization [Time frame: 1 year]
Secondary outcome measures (12)
- composite of periprocedural death, stroke, or myocardial infarction [Time frame: 30±3 days]
- occurence of non-fatal stroke and TIA [Time frame: 1 year]
- occurence of nonfatal myocardial infarction [Time frame: 1 year]
- numbers of new silent cerebral infarcts on Magnetic Resonance Imaging [Time frame: 1 year]
- occurence of ipsilateral (to the stented artery) nonfatal stroke and transient ischemic attack [Time frame: 1 year]
- degree of in-stent restenosis (≥50%) on Computed Tomography Angiography [Time frame: 1 year]
- change in collateral circulation status (assessed by Computed Tomography Angiography or Digital Subtraction Angiograph) from baseline to 12 months [Time frame: 1 year]
- all-cause mortality [Time frame: 1 year]
- changes in modified Rankin Scale (mRS) scores over time [Time frame: 1 year]
- occurrence of contrast staining on brain computerized tomography [Time frame: 1 hours and 24 hours after carotid artery stenting]
- occurrence of cerebral hyperperfusion syndrome [Time frame: 24 hours after carotid artery stenting]
- occurence of new infarct on brain magnetic resonance imaging [Time frame: 24 hours after carotid artery stenting]
Eligibility criteria
Inclusion criteria
- 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;
- Essen Score ≥ 3;
- Modified Rankin Scale score of 0 or 1;
- Signed informed consent.
Exclusion criteria
- 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
- Severe comorbid conditions with a life expectancy of less than 1 year
- Participation in another clinical trial within the past 3 months or ongoing participation
- Any other circumstances deemed by the investigator as unsuitable for participation in this clinical study.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Department of Neurology, General Hospital of Northern Theater Command — Shenyang
Identifiers
NCT: NCT07412249 · Y (2026) 14