O14/141 FIRST, International Prospective Multicenter Study of Endovascular Treatment of Intracranial Aneurysms with SILK VISTA and SILK VISTA BABY: 1-year study results

Introduction

Flow diverters (FD) are increasingly used, becoming an established treatment option for complex intracranial aneurysms. Delivered through a 0.017’ microcatheter, the low-profile Silk Vista Baby FD (Balt Extrusion SAS, France) has widened treatment opportunities in distal vasculature.

Aim of Study

The purpose of this study is to assess the Silk Vista and the Silk Vista Baby FD in the treatment of intracranial aneurysm.

Methods

An international, prospective, observational, multicenter study including 29 centers was performed on patients with ruptured or unruptured, untreated or recanalized (previously treated with coils exclusively) aneurysms and followed for 5 years. The primary safety endpoint was the morbi-mortality at 12 months post-procedure. Efficacy was assessed by the rate of aneurysm occlusion rate immediately after the procedure, at 30 days, 6 months and 12 months post-procedure. Long-term safety and efficacy will be assessed at 3- and 5-years post-procedure.

Results

Between November 2019 and June 2021, 232 patients were enrolled and completed follow-up at 1-year. Statistical analyses are underway and presentation of the study results will be made at the congress.

Conclusion

This is the largest prospective cohort study of patients with aneurysms treated with Silk Vista and Silk Vista Baby to date. Our result will reflect the use of Silk Vista and Silk Vista Baby in real-world conditions.

Disclosure of Interest

Study sponsored by BALT.