Remote Ischemic Conditioning Plus Stenting for Symptomatic Carotid Artery Stenosis (RICSICAS)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Carotid Stenosis
• Intervention / Treatment: Device: Remote ischemic conditioning

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shenyang, China, 110016
    • Recruiting
    • Department of Neurology, General Hospital of Northern Theater Command
    • Contact: Hui-Sheng Chen, Ph.D.; Phone Number: +86 13352452086; Email: chszh@aliyun.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: RIC group; 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.	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.
No Intervention: Control group; no RIC treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
all-cause mortality		1 year
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
changes in modified Rankin Scale (mRS) scores over time	The minimum and maximum values of mRS are 0 and 6, respectively; higher score mean a worse outcome	1 year
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

Collaborators and Investigators

• Sponsor: General Hospital of Shenyang Military Region

Study record dates

Study Major Dates

• Study Start (Actual): March 4, 2026
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): November 30, 2027

Study Registration Dates

• First Submitted: February 9, 2026
• First Submitted That Met QC Criteria: February 9, 2026
• First Posted (Actual): February 17, 2026

Study Record Updates

• Last Update Posted (Actual): April 3, 2026
• Last Update Submitted That Met QC Criteria: March 30, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Arterial Occlusive Diseases; Carotid Artery Diseases; Carotid Stenosis
• Other Study ID Numbers: Y (2026) 14

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No