Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07412249

Remote Ischemic Conditioning Plus Stenting for Symptomatic Carotid Artery Stenosis

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Neurology, General Hospital of Northern Theater Command

Shenyang, 110016, China

Location status: Recruiting

Location contact

Hui-Sheng Chen, Ph.D.

CONTACT

[email protected]

+86 13352452086

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. time to the first occurrence of any component of the composite endpoint within 12 months post-randomization

    Time frame: 1 year

    the composite endpoint includes ischemic stroke, hemorrhagic stroke, myocardial infarction [including coronary revascularization], TIA, or vascular death

Secondary outcomes

  1. composite of periprocedural death, stroke, or myocardial infarction

    Time frame: 30±3 days

  2. occurence of non-fatal stroke and TIA

    Time frame: 1 year

  3. occurence of nonfatal myocardial infarction

    Time frame: 1 year

  4. numbers of new silent cerebral infarcts on Magnetic Resonance Imaging

    Time frame: 1 year

  5. occurence of ipsilateral (to the stented artery) nonfatal stroke and transient ischemic attack

    Time frame: 1 year

  6. degree of in-stent restenosis (≥50%) on Computed Tomography Angiography

    Time frame: 1 year

  7. change in collateral circulation status (assessed by Computed Tomography Angiography or Digital Subtraction Angiograph) from baseline to 12 months

    Time frame: 1 year

  8. all-cause mortality

    Time frame: 1 year

  9. changes in modified Rankin Scale (mRS) scores over time

    Time frame: 1 year

    The minimum and maximum values of mRS are 0 and 6, respectively; higher score mean a worse outcome

  10. occurrence of contrast staining on brain computerized tomography

    Time frame: 1 hours and 24 hours after carotid artery stenting

  11. occurrence of cerebral hyperperfusion syndrome

    Time frame: 24 hours after carotid artery stenting

  12. occurence of new infarct on brain magnetic resonance imaging

    Time frame: 24 hours after carotid artery stenting

Sponsors and collaborators

Lead sponsor

General Hospital of Shenyang Military Region

Other

Registry information

Official study title

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

Acronym: RICSICAS

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Feb 17, 2026
Registry last updated
Apr 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.