Evaluation of using a double helical, closed-cell stent-retriever (Skyflow) for thrombectomy procedures in acute arterial occlusion: A preclinical study and a clinical trial

Abstract

Background and purpose

Stent retriever thrombectomy is the standard therapeutic approach for ischemic stroke with acute large-vessel occlusion. This study evaluated the safety and efficacy of a new thrombectomy device (Skyflow) in the treatment of acute ischemic stroke.

Methods

After an arterial occlusion model was established, stent-retriever thrombectomy was performed. Digital subtraction angiography (DSA) and autopsy were carried out immediately after thrombectomy in six animals in the acute experimental group. Simulated stent-retriever thrombectomy was performed for three animals in the subacute experimental group, and follow-up angiography and vascular pathological examination were assessed 90 days after the operation. In the clinical trial, 192 patients with intracranial anterior circulation large vessel occlusion, within 8 ​h of symptom onset, were included to undergo thrombectomy with either Skyflow or Solitaire FR stent retriever. Efficacy and safety endpoints were recorded (including successful reperfusion, favorable clinical outcomes, time from puncture to reperfusion, instrument operation success rates and National Institutes of Health Stroke Scale (NIHSS) scores at 7 days for efficacy endpoints, and symptomatic intracranial hemorrhage (sICH), subarachnoid hemorrhage (SAH) and all-cause mortality rates for safety endpoints).

Results

All blood vessels achieved successful recanalization in the animal models. In the clinical trial, successful recanalization was attained in 88.4% of patients of the Skyflow group, which was comparable to that of the Solitaire FR group (82.5%) in the full analysis set of the clinical trial. There were no severe complications on DSA, an animal autopsy, or vessel pathological examination in animal experiments. Additionally, no statistically significant difference was observed between the Skyflow and Solitaire FR groups in the clinical trial regarding the safety endpoints.

Conclusion

This study showed that the new Skyflow stent retriever is safe and effective for the treatment of acute large vessel occlusion, as demonstrated in our animal study and human trial.