Remote arm‑cuff conditioning plus stent placement for symptomatic carotid narrowing

Remote Ischemic Conditioning Plus Stenting for Symptomatic Carotid Artery Stenosis (RICSICAS): A Prospective, Randomized Controlled, Blind Endpoint, Single-Center Study

This study tests whether regular remote limb ischemic conditioning after carotid artery stenting can lower major vascular events and improve outcomes for adults with symptomatic carotid artery narrowing.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 300 (estimated)
• Ages: 40 Years and up
• Sex: All
• Sponsor: General Hospital of Shenyang Military Region (Academic / other)
• Locations: 1 site (Shenyang)
• Trial ID: NCT07412249 on ClinicalTrials.gov

What this trial studies

This interventional study enrolls adults with recent ipsilateral cerebral ischemic symptoms and moderate-to-severe internal carotid artery stenosis who are scheduled for carotid artery stenting, and applies chronic remote ischemic conditioning after the procedure while monitoring patients over the long term. Remote ischemic conditioning (RIC) is a non-invasive approach that uses brief, repeated limb ischemia cycles to trigger protective mechanisms in the brain. The trial tracks incidence of major vascular events and clinical functional outcomes and records safety data related to prolonged RIC use. Results will determine whether chronic RIC adds long-term benefit to patients who receive carotid stents.

Who should consider this trial

Good fit: Adults aged 40 or older with symptomatic moderate-to-severe internal carotid artery stenosis, ipsilateral ischemic symptoms within the past 180 days, an Essen score ≥ 3, a modified Rankin Scale of 0–1, and a planned carotid artery stent are ideal candidates.

Not a fit: Patients with contraindications to RIC (for example significant peripheral or upper-limb vascular disease, severe soft tissue injury or fracture of the arm), uncontrolled severe hypertension, significant subclavian stenosis/steal, severe hematologic or coagulation disorders, very limited life expectancy, or who do not have recent symptomatic carotid stenosis may not receive benefit from this intervention.

Why it matters

Potential benefit: If successful, this approach could reduce major vascular events and improve recovery and long-term function after carotid artery stenting.

How similar studies have performed: Smaller and short-term studies of remote ischemic conditioning in stroke and in patients undergoing carotid procedures have suggested potential benefit, but long-term efficacy and safety after carotid stenting remain unproven.

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.

Where this trial is running

Shenyang

• Department of Neurology, General Hospital of Northern Theater Command — Shenyang, China (Recruiting)

Conditions Carotid Stenosis