Remote Ischemic Conditioning Plus Stenting for Symptomatic Carotid Artery Stenosis

General Hospital of Shenyang Military Region300 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

300

Conditions

Carotid Stenosis

Interventions

Remote ischemic conditioning

Eligibility

Sex: ALLMin age: 40 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

Time frame: 1 year

Secondary Outcomes

composite of periprocedural death, stroke, or myocardial infarction

Time frame: 30±3 days

occurence of non-fatal stroke and TIA

Time frame: 1 year

occurence of nonfatal myocardial infarction

Time frame: 1 year

numbers of new silent cerebral infarcts on Magnetic Resonance Imaging

Time frame: 1 year

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

Time frame: 1 year

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

Time frame: 1 year

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

Time frame: 1 year

all-cause mortality

Time frame: 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

Time frame: 1 year

occurrence of contrast staining on brain computerized tomography

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

occurrence of cerebral hyperperfusion syndrome

Time frame: 24 hours after carotid artery stenting

occurence of new infarct on brain magnetic resonance imaging

Time frame: 24 hours after carotid artery stenting

Remote Ischemic Conditioning Plus Stenting for Symptomatic Carotid Artery Stenosis

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes