NCT07412249

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
18mo left

Started Mar 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress13%
Mar 2026Nov 2027

First Submitted

Initial submission to the registry

February 9, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 17, 2026

Completed
15 days until next milestone

Study Start

First participant enrolled

March 4, 2026

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2027

Last Updated

March 9, 2026

Status Verified

March 1, 2026

Enrollment Period

1.7 years

First QC Date

February 9, 2026

Last Update Submit

March 5, 2026

Conditions

Carotid Stenosis

Outcome Measures

Primary Outcomes (1)

  • 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 \[including silent infarcts detected on imaging\], myocardial infarction \[including coronary revascularization\], TIA, or vascular death

    1 year

Secondary Outcomes (9)

  • 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

  • +4 more secondary outcomes

Study Arms (2)

RIC group

EXPERIMENTAL

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

Control group

NO INTERVENTION

no RIC treatment

Interventions

Remote ischemic conditioningDEVICE

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.

RIC group

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Neurology, General Hospital of Northern Theater Command

Shenyang, 110016, China

RECRUITING

MeSH Terms

Conditions

Carotid Stenosis

Condition Hierarchy (Ancestors)

Carotid Artery DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesArterial Occlusive DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

February 9, 2026

First Posted

February 17, 2026

Study Start

March 4, 2026

Primary Completion (Estimated)

November 30, 2027

Study Completion (Estimated)

November 30, 2027

Last Updated

March 9, 2026

Record last verified: 2026-03

Locations

CN(1)