Carotid Stenosis
Conditions
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.
Interventions
DEVICERemote 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.
Sponsors
General Hospital of Shenyang Military Region
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
Countries
China
Outcome results
None listed