Initial experience with a new distal intermediate and aspiration catheter in the treatment of acute ischemic stroke: clinical safety and efficacy

J Neurointerv Surg. 2016 Jul;8(7):714-8. doi: 10.1136/neurintsurg-2015-011801. Epub 2015 May 29.

Abstract

Purpose: To describe our initial experience with the novel 5 F SOFIA (Soft Torqueable catheter Optimized For Intracranial Access) intermediate and aspiration catheter for endovascular treatment of patients with acute ischemic stroke.

Methods: A retrospective review was performed in three centers of prospectively collected data of all stroke patients who underwent endovascular therapy using the SOFIA catheter. Patients were enrolled between November 2013 and December 2014. The primary endpoint of the study was accessibility of the thrombus with the SOFIA catheter. As a secondary endpoint, the study assessed recanalization success (Thrombolysis In Cerebral Infarction (TICI) ≥2b). Clinical presentation on admission and discharge was also documented. In addition, catheter- and procedure-related complications (particularly thromboembolic complications) were recorded.

Results: The SOFIA catheter was used in 115 acute stroke procedures. In 110 cases (96%) the catheter could be advanced to the occlusion site. After mechanical thrombectomy, successful recanalization (TICI ≥2b) was documented in 86.9%. There were no complications related to positioning of the catheter. Distal thrombus migration into a new vascular territory occurred in three patients following thrombectomy with a stent retriever (2.6%). The mean NIH Stroke Scale (NIHSS) score on admission was 16.8±6 and at discharge the mean NIHSS score was 8.2±7.7. Sixteen patients died.

Conclusions: The SOFIA catheter is a safe and efficient catheter for endovascular stroke therapy.

Keywords: Catheter; Stroke; Thrombectomy.

Publication types

  • Multicenter Study

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Aged, 80 and over
  • Brain Ischemia / diagnostic imaging*
  • Brain Ischemia / surgery*
  • Catheters*
  • Child
  • Endovascular Procedures / instrumentation
  • Endovascular Procedures / methods
  • Female
  • Humans
  • Male
  • Middle Aged
  • Patient Safety*
  • Prospective Studies
  • Retrospective Studies
  • Stents
  • Stroke / diagnostic imaging*
  • Stroke / surgery*
  • Thrombectomy / instrumentation
  • Thrombectomy / methods
  • Treatment Outcome
  • Young Adult