Remote ischemic conditioning plus stenting for symptomatic carotid artery stenosis (RICSICAS): rationale and design
- 1Department of Neurology, General Hospital of Northern Theater Command , ,
Abstract
Background: 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.
Objective: To evaluate whether chronic RIC reduces the incidence of major vascular events in high-risk patients with carotid artery stenosis who received CAS.
Methods: RICSICAS is a prospective, randomized, open-label, blinded endpoint evaluation (PROBE), single-center trial. We plan to enroll 450 high-risk patients with symptomatic carotid artery stenosis (Essen score ≥ 3) scheduled for CAS. Participants will be randomly assigned (1:1) to receive either standard medical therapy plus RIC or standard medical therapy alone. 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, thus constituting a combined peri-procedural and chronic RIC strategy. The primary efficacy endpoint is the composite of stroke, myocardial infarction, TIA, and vascular death within 12 months. Safety endpoints include any RIC-related adverse event (e.g., limb pain, petechiae, peripheral nerve injury), and any serious adverse event.
Sample Size: Assuming a 12-month event rate of 20% in the control group and a 40% relative risk reduction with RIC, with 80% power and a two-sided α of 0.05, 355 patients are required. Accounting for a 20% dropout rate/loss-to-follow-up, as well as the consumption of the interim analysis, the total sample size is set as 450.
Discussion: This trial will provide high-level evidence on the role of long-term RIC as an adjunctive therapy for high-risk patients with symptomatic carotid artery stenosis undergoing CAS.
Clinical Trial Registration: Clinicaltrials.gov , identifier: NCT07412249.
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BibTeX
@article{qiu2026remote,
title = {{Remote ischemic conditioning plus stenting for symptomatic carotid artery stenosis (RICSICAS): rationale and design}},
author = {Jing Qiu and Wei Li and Yong-Gang Zhao and Jia-Qi Wang and Lu Wang and Hui-Sheng Chen},
journal = {Frontiers in neurology},
year = {2026},
month = sep,
doi = {10.3389/fneur.2026.1915534},
url = {https://europepmc.org/article/PMC/PMC13661333},
note = {CC BY},
}
RIS
TY - JOUR
TI - Remote ischemic conditioning plus stenting for symptomatic carotid artery stenosis (RICSICAS): rationale and design
AU - Jing Qiu
AU - Wei Li
AU - Yong-Gang Zhao
AU - Jia-Qi Wang
AU - Lu Wang
AU - Hui-Sheng Chen
PY - 2026
DA - 2026/09/30
JO - Frontiers in neurology
DO - 10.3389/fneur.2026.1915534
UR - https://europepmc.org/article/PMC/PMC13661333
AB - Background: 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. Objective: To evaluate whether chronic RIC reduces the incidence of major vascular events in high-risk patients with carotid artery stenosis who received CAS. Methods: RICSICAS is a prospective, randomized, open-label, blinded endpoint evaluation (PROBE), single-center trial. We plan to enroll 450 high-risk patients with symptomatic carotid artery stenosis (Essen score ≥ 3) scheduled for CAS. Participants will be randomly assigned (1:1) to receive either standard medical therapy plus RIC or standard medical therapy alone. 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, thus constituting a combined peri-procedural and chronic RIC strategy. The primary efficacy endpoint is the composite of stroke, myocardial infarction, TIA, and vascular death within 12 months. Safety endpoints include any RIC-related adverse event (e.g., limb pain, petechiae, peripheral nerve injury), and any serious adverse event. Sample Size: Assuming a 12-month event rate of 20% in the control group and a 40% relative risk reduction with RIC, with 80% power and a two-sided α of 0.05, 355 patients are required. Accounting for a 20% dropout rate/loss-to-follow-up, as well as the consumption of the interim analysis, the total sample size is set as 450. Discussion: This trial will provide high-level evidence on the role of long-term RIC as an adjunctive therapy for high-risk patients with symptomatic carotid artery stenosis undergoing CAS. Clinical Trial Registration: Clinicaltrials.gov , identifier: NCT07412249.
SN - 1664-2295
ER -