First-In-Man Procedural Experience with the Novel EmboTrap® Revascularization Device for the Treatment of Ischemic Stroke-A European Multicenter Series

Clin Neuroradiol. 2016 Jun;26(2):221-8. doi: 10.1007/s00062-014-0352-0. Epub 2014 Nov 1.

Abstract

Purpose: We describe safety and efficacy aspects of mechanical thrombectomy with the novel stent-type clot retrieval device EmboTrap for revascularization of large-artery occlusions in acute ischemic stroke.

Materials and methods: A total of 40 patients with acute ischemic stroke due to large-artery occlusion were treated in five European centers. Clinical and procedural data were collected; self-reported angiographic results and neurologic outcome (discharge and 90 days) were assessed in a standardized manner.

Results: The median National Institutes of Health Stroke Scale at admittance was 16; no patient was treated after 12 h. Intravenous thrombolysis (IVT) was received by 65 % of patients. The territorial distribution was as follows: 87.5 % in the anterior circulation: 62.5 % middle cerebral artery and 25 % internal carotid artery (ICA) terminus, comprising 20 % tandem occlusions; and 12.5 % in the posterior circulation, all of which were vertebrobasilar. Revascularization of TICI 2b-3 was achieved in 38 of 40 (95 %) treatments. Additional devices were utilized in 11 of 40 (28 %) cases after a mean of 2.6 passes with EmboTrap prior to switching. The mean number of EmboTrap passes needed was 1.8, with a mean procedural time to reperfusion of 54 min. One patient (2.5 %), who had not received IVT, experienced symptomatic intracranial hemorrhage post-interventionally. Procedural complications were encountered in 2 of 40 cases (5 %); both patients exhibited ICA dissection that was treated conservatively without clinical sequelae. There were no device-related complications. Of 23 available patients, 8 (35 %) had a good outcome after 90 days.

Conclusion: The procedural results from these five centers suggest that EmboTrap is technically safe. Successful recanalization rates can be expected to be within the range of other stent retrievers.

Keywords: EmboTrap; Ischemic stroke; Mechanical thrombectomy; Recanalization; Solitaire; Stent retriever; Stentriever; Trevo.

Publication types

  • Clinical Trial
  • Multicenter Study

MeSH terms

  • Cerebral Hemorrhage / diagnosis
  • Cerebral Hemorrhage / etiology*
  • Cerebral Hemorrhage / prevention & control
  • Cerebral Revascularization / adverse effects*
  • Cerebral Revascularization / instrumentation*
  • Equipment Design
  • Equipment Failure Analysis
  • Europe
  • Female
  • Humans
  • Male
  • Mechanical Thrombolysis / adverse effects*
  • Mechanical Thrombolysis / instrumentation*
  • Pilot Projects
  • Radiography, Interventional
  • Stroke / diagnostic imaging
  • Stroke / therapy*
  • Treatment Outcome