Remote Ischemic Conditioning Plus Stenting for Symptomatic Carotid Artery Stenosis

NCT07412249 — Not applicable, Recruiting, 300 participants, General Hospital of Shenyang Military Region

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

Registry	NCT07412249, acronym RICSICAS
Status	Recruiting
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: single, treatment
Enrollment	300 (Estimated)
Sponsor	General Hospital of Shenyang Military Region (Other)
Conditions	Carotid Stenosis
Interventions	Remote ischemic conditioning (Device)
Dates	start 2026-03-04, primary completion 2027-11-30 (estimated), completion 2027-11-30 (estimated), first posted 2026-02-17, last updated 2026-04-03
Locations	1 site in China

-Summary

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.

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+Arms and interventions

Arm	Type	Interventions	Description
RIC group	Experimental	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.
Control group	No intervention		no RIC treatment

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.

+Outcome measures

Primary outcomes

time to the first occurrence of any component of the composite endpoint within 12 months post-randomization [1 year]: 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 [30±3 days]
occurence of non-fatal stroke and TIA [1 year]
occurence of nonfatal myocardial infarction [1 year]
numbers of new silent cerebral infarcts on Magnetic Resonance Imaging [1 year]
occurence of ipsilateral (to the stented artery) nonfatal stroke and transient ischemic attack [1 year]
degree of in-stent restenosis (≥50%) on Computed Tomography Angiography [1 year]
change in collateral circulation status (assessed by Computed Tomography Angiography or Digital Subtraction Angiograph) from baseline to 12 months [1 year]
all-cause mortality [1 year]
changes in modified Rankin Scale (mRS) scores over time [1 year]: The minimum and maximum values of mRS are 0 and 6, respectively; higher score mean a worse outcome
occurrence of contrast staining on brain computerized tomography [1 hours and 24 hours after carotid artery stenting]
occurrence of cerebral hyperperfusion syndrome [24 hours after carotid artery stenting]
occurence of new infarct on brain magnetic resonance imaging [24 hours after carotid artery stenting]

+Eligibility

Sex: All, ages: 40 Years to any

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.

+Locations (1)

Facility	City	Country	Status
Department of Neurology, General Hospital of Northern Theater Command	Shenyang	China	Recruiting

+Publications

Results publication: Qiu J, Li W, Zhao YG, Wang JQ, Wang L, Chen HS. Remote ischemic conditioning plus stenting for symptomatic carotid artery stenosis (RICSICAS): rationale and design. Front Neurol. 2026 Sep 30;17:1915534. doi: 10.3389/fneur.2026.1915534. eCollection 2026. PMID 42876495