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Two different distal protections on cerebral microembolization of vulnerable plaque during carotid artery stenting
Lin Yan1, Liqi Shu2, Sun Xinyi1
1Department of Neurosurgery, Xuanwu Hospital, Capital Medical University, China International Neuroscience Institute (China-INI), Beijing, 100053, China.
Insights
This study compares two embolic protection devices (EPDs) during carotid artery stenting (CAS) in Chinese patients. It evaluates the Emboshield NAV6™ against the Spider FX™ for safety and effectiveness in preventing stroke.
Area of Science:
- Cardiovascular Medicine
- Interventional Neurology
- Medical Devices
Background:
- Carotid artery stenting (CAS) is a key treatment for high-risk carotid stenosis, especially in China.
- No randomized trials have compared different embolic protection devices (EPDs) during CAS.
- This study focuses on newer EPDs: Spider FX™ and Emboshield NAV6™.
Purpose of the Study:
- To compare the safety and effectiveness of Spider FX™ versus Emboshield NAV6™ during CAS.
- To evaluate distal embolic protection provided by these two EPDs.
- To provide evidence for optimal EPD selection in high-risk patients undergoing CAS.
Main Methods:
- A prospective, single-center, randomized, controlled, blinded-endpoint trial.
- 172 high-risk carotid stenosis patients undergoing CAS will be enrolled (1:1 randomization).
- Primary outcome: new ipsilateral ischemic lesions on DWI within 7 days; secondary outcomes include microembolic signals (MES) and safety events.
Main Results:
- Results are pending publication.
Conclusions:
- The study will determine if Emboshield NAV6™ offers superior embolic protection compared to Spider FX™.
- Findings may guide clinical decisions on EPD selection for CAS.
- Results are specific to the Chinese population, requiring cautious generalization.
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.
