Trials · 2026
Two different distal protections on cerebral microembolization of vulnerable plaque during carotid artery stenting (CASH-ES): study protocol for a randomized controlled trial.
СтатьяПротокол клинического исследованияНазвание и аннотация: Перевод в очереди
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Yan Lin, Shu Liqi, Xinyi Sun, Zhang Nan, Lu Yake, Feng Yiding, Wang Yabing, Gao Peng, Ma Yan, Chen Jian, Yang Bin, Feng Yao, Chen Yanfei, Jiao Liqun
Аннотация
BACKGROUND: Carotid artery stenting (CAS) is a widely used procedure for patients with high-risk carotid stenosis, particularly in the Chinese population. However, there are no randomized trials examining the comparative efficacy and safety of different embolic protection devices (EPDs) used during CAS. This study aims to evaluate the safety and effectiveness of two newer-generation EPDs, Spider FX™ and Emboshield NAV6™, using a comprehensive approach that includes intraoperative monitoring, postoperative imaging, and clinical outcomes. Given the specific focus on a Chinese population, caution should be applied when generalizing findings to other ethnic groups.
METHODS: This is a prospective, single-center, randomized, controlled, and blinded-endpoint trial designed to compare the performance of Spider FX™ and Emboshield NAV6™ in high-risk carotid stenosis patients undergoing CAS. A total of 172 patients will be enrolled, accounting for an estimated 20% dropout rate. The randomization will be performed in a 1:1 ratio between the two devices. The primary outcome is new ipsilateral ischemic lesions on diffusion-weighted imaging (DWI) within 7 days after CAS. Secondary outcomes include the number, size, and location of new cerebral ischemic lesions on DWI, and the count of microembolic signals (MES) detected by TCCD monitoring during the procedure. Safety assessments will include procedural complications, myocardial infarction, and mortality within 7 days.
DISCUSSION: The results of this trial will provide crucial evidence on whether the Emboshield NAV6™ device offers superior distal embolic protection compared to the Spider FX™ in patients undergoing CAS. This could potentially guide clinicians in selecting the most effective EPD for high-risk carotid stenosis patients.
TRIAL REGISTRATION: ClinicalTrials.gov NCT04904250 (URL: http://www.
CLINICALTRIALS: gov ) Registered on May 27, 2021.
METHODS: This is a prospective, single-center, randomized, controlled, and blinded-endpoint trial designed to compare the performance of Spider FX™ and Emboshield NAV6™ in high-risk carotid stenosis patients undergoing CAS. A total of 172 patients will be enrolled, accounting for an estimated 20% dropout rate. The randomization will be performed in a 1:1 ratio between the two devices. The primary outcome is new ipsilateral ischemic lesions on diffusion-weighted imaging (DWI) within 7 days after CAS. Secondary outcomes include the number, size, and location of new cerebral ischemic lesions on DWI, and the count of microembolic signals (MES) detected by TCCD monitoring during the procedure. Safety assessments will include procedural complications, myocardial infarction, and mortality within 7 days.
DISCUSSION: The results of this trial will provide crucial evidence on whether the Emboshield NAV6™ device offers superior distal embolic protection compared to the Spider FX™ in patients undergoing CAS. This could potentially guide clinicians in selecting the most effective EPD for high-risk carotid stenosis patients.
TRIAL REGISTRATION: ClinicalTrials.gov NCT04904250 (URL: http://www.
CLINICALTRIALS: gov ) Registered on May 27, 2021.