Introduction The iNstroke aspiration thrombus extraction device by iVascular is a single-lumen device (0.71’) with variable stiffness form proximal to distal designed to extract emboli and thrombi from neurovascular blood vessels.

Aim of Study The aim of this study was to evaluate the efficacy and safety of the iNstroke aspiration device in mechanical thrombectomy for patients presenting with acute ischemic stroke due to large vessel occlusion within 24 hours from symptom onset.

Methods ASPIC-01 is a prospective, single-site, clinical trial. Efficacy endpoints: successful recanalization (mTICI≥2b) and mRS 0-2 at 90 days. Safety endpoints: combined serious adverse events (SAE) at 24 hours and all-cause mortality at 90 days. The intention-to-treat (ITT) set included all subjects meeting inclusion criteria. The device implant population included all subjects in whom only iNstroke was used. An interim analysis was performed in 48 patients.

Results Mean age: 70.3 ± 12.3 years, 62.5% male. Baseline: NIHSS median 19.5 [13.0-25.0], ASPECTS median 9.0 [7.0-10.0]. In ITT: recanalization 68.8% (95% CI 53.8-81.3), 90-day mRS 0-2 62.5% (95% CI 47.4-76.1%). Device implant population: recanalization 100% (95% CI 87.2-100.0), 90-day mRS 0-2 63% (95% CI 42.4-80.6%). No SAEs related to the device were reported. All-cause mortality rate at 90 days was 14.6% (95% CI 6.1-27.8%).

Conclusion The iNstroke aspiration device represents a safe and effective option for performing neurothrombectomy using primary aspiration, with a high recanalization rate observed in selected cases.

Disclosure of Interest no.