Section 4 of 10
Study limitations and future perspectives
Xiangxiang Ru, Xinxi Li, Lei Zhang, Jingdong Tang, Shuai Jiang, Yerbao Zaiying, Gulitenken Aihemaitijiang, Donglin Li, Dilinerkezi Ablimit, Li Chen, Yuxin Deng, Halizati Halimulati, and Ye Tian · about 1 minutes
This study has several limitations.
The most critical limitation is the lack of a contemporaneous head-to-head control group. Literature-based comparisons (Table VII) are limited by inherent heterogeneity across studies and cannot substitute for rigorous controlled trials. All results presented are preliminary, and any claims regarding relative performance should be interpreted with extreme caution.
Next are some additional limitations.
First, the sample size was small (n = 6), and the in vivo experiments used an abdominal aortoiliac bifurcation model rather than a true thoracic aortic arch model. This model was selected to eliminate confounding anatomical complexity and enable standardized evaluation of device operability and immediate biosafety. However, differences in three-dimensional curvature, flow dynamics, and vessel compliance between this model, and the human thoracic arch may affect catheter maneuverability and filter stability in ways not fully captured herein; thus, the in vivo results should be interpreted as preliminary. Importantly, the in vitro experiments replicated human types Ⅰto Ⅲ aortic arch anatomies to validate core device performance—including puncture accuracy and embolic capture—under clinically realistic conditions.
Second, embolus capture efficiency was assessed using spherical fluorescent microspheres, which may not fully recapitulate the irregular morphology of atherosclerotic debris; consequently, the reported capture rates likely represent conservative estimates.
Third, the study employed healthy animals and assessed only immediate postoperative outcomes; therefore, no conclusions can be drawn regarding mid- or long-term safety, branch stent patency, or delayed device-related adverse events.
Fourth, the operator feedback assessment involved only two surgeons and is presented as preliminary observational data, not a definitive usability validation.
Future studies will focus on: (1) optimizing the puncture component design; (2) performing validation in atherosclerotic disease models with comprehensive neurological assessments and long-term follow-up; (3) conducting first-in-human clinical trials; (4) evaluating device usability in larger, blinded assessments involving operators with varying experience levels.