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Original research
First-in-man experience of the Versi Retriever in acute ischemic stroke
  1. Nobuyuki Sakai1,
  2. Hirotoshi Imamura1,
  3. Hidemitsu Adachi1,
  4. Shoichi Tani1,
  5. So Tokunaga1,
  6. Takayuki Funatsu1,
  7. Keita Suzuki1,
  8. Hiromasa Adachi1,
  9. Natsuhi Sasaki1,
  10. Shuhei Kawabata1,
  11. Ryo Akiyama1,
  12. Kazufumi Horiuchi1,
  13. Nobuyuki Ohara1,
  14. Tomoyuki Kono1,
  15. Satoru Fujiwara1,
  16. Naoki Kaneko2,
  17. Satoshi Tateshima2
  1. 1 Department of Neurosurgery, Neurology and Comprehensive Stroke Center, Kobe City Medical Center General Hospital, Kobe, Japan
  2. 2 Division of Interventional Neuroradiology, Ronald Reagan UCLA Medical Center, Los Angeles, USA
  1. Correspondence to Dr. Satoshi Tateshima, Division of Interventional Neuroradiology, University of California, Los Angeles, California, USA; stateshi{at}g.ucla.edu

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

  • stroke
  • thrombectomy
  • stent
  • intervention
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Footnotes

  • Contributors NS: study conception and design, interventions, acquisition of data, analysis and interpretation of data, drafting of the manuscript; HI, HA, ST, SoT, TF, KS, HA, NS, SK, RA, KH, NO, TK and SF: interventions, acquisition of data, critical revision of the manuscript; NK: analysis and interpretation of data, drafting of the manuscript; ST: study conception and design, analysis and interpretation of data, drafting of the manuscript.

  • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

  • Competing interests NS has been a consultant for Cerenovus, Medtronic, Microvention, Neurovasc, Penumbra and Stryker; NK has been a consultant for Neurovasc; ST holds stock in Neurovasc and has been a consultant for Cerenovus, Medtronic, Neurovasc and Stryker.

  • Patient consent Obtained.

  • Ethics approval Ethics approval was provided by the institutional review board of Kobe City Medical Center General Hospital.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Data sharing statement All data are available in the manuscript.

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