SAFE study (Safety and efficacy Analysis of FRED Embolic device in aneurysm treatment): 1-year clinical and anatomical results

J Neurointerv Surg. 2019 Feb;11(2):184-189. doi: 10.1136/neurintsurg-2018-014261. Epub 2018 Oct 8.

Abstract

Background and purpose: Flow diversion is an innovative and increasingly used endovascular treatment for intracranial aneurysms. Its initial evaluation with the first devices available showed good efficacy of this treatment with variable safety results. The Flow Direction Endoluminal Device (FRED) has a specific design and was evaluated in a single-arm, multicenter, prospective, Good Clinical Practice study: SAFE (Safety and efficacy Analysis of FRED Embolic device in aneurysm treatment). This analysis reports clinical results at 1 year and anatomical results at 6 months and 1 year.

Methods: Patients with unruptured and recanalized aneurysms located in the anterior circulation treated with FRED and FRED Jr were prospectively included. A Clinical Event Committee and a Core Laboratory independently evaluated clinical outcome and anatomical results.

Results: Thirteen interventional neuroradiology centers included 103 patients/aneurysms. Aneurysm locations were supraclinoid internal carotid artery (ICA) in 71 (68.9%), cavernous ICA in 15 (14.6%), anterior cerebral or anterior communicating artery in 9 (8.7%), and middle cerebral artery in 8 (7.8%). Most aneurysms were small (<10 mm) in 71 patients (68.9%). Cumulative 1-year mortality and morbidity rates were 2/103 (1.9%) and 3/103 (2.9%), respectively, one death being related to cancer. At 1 year, anatomical results were: complete occlusion in 66/90 patients (73.3%), neck remnant in 7/90 patients (7.8%), and aneurysm remnant in 17/90 patients (18.9%).

Conclusions: SAFE study analysis at 1 year confirms the excellent safety profile of the FRED device for aneurysm treatment, with low morbidity and mortality rates (2.9% and 1.9%, respectively) and demonstrates its efficacy (adequate occlusion in 73/90 (81.1%)).

Clinical trial registration: Unique identifier: NCT02921698; Results.

Keywords: aneurysm; flow diverter.

Publication types

  • Multicenter Study
  • Observational Study

MeSH terms

  • Adult
  • Aged
  • Aged, 80 and over
  • Embolization, Therapeutic / adverse effects
  • Embolization, Therapeutic / instrumentation*
  • Embolization, Therapeutic / trends
  • Endovascular Procedures / adverse effects
  • Endovascular Procedures / instrumentation
  • Endovascular Procedures / trends
  • Female
  • Humans
  • Intracranial Aneurysm / diagnostic imaging*
  • Intracranial Aneurysm / therapy*
  • Male
  • Middle Aged
  • Prospective Studies
  • Self Expandable Metallic Stents* / adverse effects
  • Self Expandable Metallic Stents* / trends
  • Treatment Outcome

Associated data

  • ClinicalTrials.gov/NCT02921698