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Remote Ischemic Conditioning Plus Stenting for Symptomatic Carotid Artery Stenosis (RICSICAS): A Prospective, Randomized Controlled, Blind Endpoint, Single-Center Study
Led by General Hospital of Shenyang Military Region · Updated on 2026-04-03
300
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of remote ischemic conditioning (RIC) combined with carotid artery stenting (CAS) in patients who have symptomatic moderate to severe carotid artery stenosis. This study aims to find out if chronic RIC can lower the risk of major vascular events and improve clinical outcomes in high-risk patients after receiving CAS. The trial is a prospective, randomized controlled study designed to assess long-term benefits and safety of RIC in this group. The treatment involves a device-based RIC protocol where a cuff is inflated on both upper arms to 200 mmHg for 5 minutes, followed by 5 minutes of deflation, repeated for five cycles. This is done once or twice daily, starting three days before CAS and continuing for 12 months after the procedure. Participants are randomly assigned to either the RIC group receiving this treatment or a control group with no RIC treatment. Participants will be involved in the study for at least 12 months post-randomization, during which researchers will track the time until major vascular events occur. Various assessments include monitoring for stroke, transient ischemic attacks, myocardial infarction, in-stent restenosis, and brain imaging to detect new infarcts or tissue changes. Safety evaluations will occur shortly after the stenting procedure, with follow-up visits assessing neurological status and overall mortality. The study also measures functional outcomes using the modified Rankin Scale over the course of the year.
CONDITIONS
Brief Title
Remote Ischemic Conditioning Plus Stenting for Symptomatic Carotid Artery Stenosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 40 years or older
- 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 stenting
- Essen Score of 3 or higher
- Modified Rankin Scale score of 0 or 1
- Signed informed consent
You will not qualify if you...
- Uncontrolled severe hypertension (systolic > 180 mmHg or diastolic > 110 mmHg despite medication)
- Subclavian artery stenosis 50% or greater 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 life expectancy less than 1 year
- Participation in another clinical trial within the past 3 months or ongoing participation
- Any other conditions deemed unsuitable by the investigator for study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo carotid artery stenting as part of their treatment for symptomatic carotid artery stenosis.
1 visit (in-person) on the day of stenting
Duration - Approximately 12 months
Participants in the experimental group perform remote ischemic conditioning involving bilateral upper-arm cuff inflation 1-2 times daily, starting 3 days before stenting and continuing for 12 months post-procedure.
Regular self-administered sessions daily; clinical visits as scheduled by study team
Duration - 12 months
Participants are monitored for clinical outcomes including occurrence of stroke, myocardial infarction, and other related events for up to 12 months after randomization.
Scheduled visits including assessments at 24 hours, 30 days, and periodic follow-up visits up to 12 months
Trial Site Locations
Total: 1 location
1
Department of Neurology, General Hospital of Northern Theater Command
Shenyang, China, 110016
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How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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