First-in-man experience of the Versi Retriever in acute ischemic stroke

Abstract

Objective: To describe our initial experience with the Versi Retriever for mechanical thrombectomy in patients with acute ischemic stroke.

Methods: This study is a single-center, single-arm, first-in-man registry under institutional review board control to evaluate the efficacy and safety of the new stent retriever, the Versi Retriever. Patients with acute ischemic stroke were consecutively enrolled between September and November 2017. The clinical and procedural data were retrospectively analyzed. The angiographic result after the procedure was self-graded based on the Thrombolysis in Cerebral Infarction (TICI) scale by each operator.

Results: Eleven patients with a mean age of 69.4 years were treated with the Versi Retriever. Median National Institutes of Health Stroke Scale score on admission was 16 (IQR 10-34). The occluded vessel was located in the anterior circulation in 81.8%. Revascularization rates of TICI 2b-3 and TICI 3 at final angiogram were achieved in 100% and 63.6%, respectively. A favorable functional outcome (modified Rankin Scale 0-2) at 90 days was obtained in 72.7%. No symptomatic intracranial hemorrhage occurred and no procedure-related complication was observed.

Conclusions: Our initial experience suggests that the Versi Retriever is a safe and effective stent retriever for mechanical thrombectomy in patients with acute ischemic stroke.

Clinical trial registration: NCT03366818.

Keywords: intervention; stent; stroke; thrombectomy.