Preclinical Evaluation of the WAVE-track Aspiration Catheter: Safety and Efficacy in the Swine Thrombectomy Model.

Abstract

RATIONALE AND OBJECTIVES: We investigated the safety and effectiveness of the WAVE-track from the perspectives of imaging and pathology with a swine thrombectomy model to provide a basis for its clinical application, using the ACE aspiration catheter as the control group. MATERIALS AND METHODS: In a swine model, various types of thrombi were prepared and placed in the maxillary artery, ascending pharyngeal artery, lingual artery, and renal artery. The WAVE-track group was considered to be the study group, and the ACE aspiration catheter was used as the control group. Thrombectomy with the ADAPT technique or/and repeatedly pushed and withdrawn with aspiration were performed in two groups. The swine were sacrificed on the day of completion of procedure or at 30 ±5 days. RESULTS: According to the angiographic analysis, although the study group showed a better trend in mTICI distribution, no significant differences were recorded in the recanalization rates between the study group and the control group (mTICI≥2b: WAVE-track group 96.15% vs. ACE group 84.37%). Furthermore, the first-pass effect rates were similar in both groups (WAVE-track group 48.08% vs. ACE group 40.63%). Procedural safety was confirmed in both groups and pathological analysis revealed no clinically significant abnormalities in the two groups. In the subgroup analysis of single-pass and multiple-pass, there were no clinically significant differences found between the two pass types in angiographic and pathology assessment. CONCLUSION: Compared to the ACE catheter, the WAVE-track aspiration catheter demonstrated high thrombectomy efficacy and safety in a swine model. Additionally, the WAVE-track aspiration catheter demonstrated a favorable safety profile even after multiple thrombectomy passes, with no clinically significant increase in vascular injury compared to single pass.