Mechanical Recanalization With Flow Restoration in Acute Ischemic Stroke "ReFlow"

Completed

Phase 2 Results N/A

Trial Description

The objective of this study is to collect data on the use of the SOLITAIR FR device for treatment of acute ischemic stroke with large artery occlusion i.e. to investigate, whether the application of SOLITAIR is a safe and feasible method for interventional recanalization of large vessels with favorable patient outcome in acute stroke therapy.

Conditions

Interventions

  • Solitaire FR, ev3 Device
    Other Names: device used: Solitaire FR, ev3, USA
    Intervention Desc: Placement of the stent in the occluded vessel segment, withdrawal in its unfolded state.

Trial Design

  • Masking: Open Label
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Single Group Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Overall frequency of favourable clinical outcome (modified Rankin Scale 0 to 2), and unfavourable clinical outcome or death (modified Rankin Scale 3 to 6) Day 90 No
Secondary Arterial recanalization of occluded target vessel measured by Thrombolysis in Cerebral Infarction (TICI)score of 2b or 3 following the use of the SOLITAIRE FR Device Day 0 No
Secondary Excellent functional clinical outcome (modified Rankin Scale 0 or 1) Day 90 No
Secondary All causes of mortality Day 90 Yes
Secondary Proportion of patients with rapid neurological improvement (more than 4 points on the NIHSS) during the first 24 hours after treatment. Day 1 No
Secondary Symptomatic intracranial haemorrhages up to 24 hours after treatment defined as homogeneous areas of haemorrhage, with or without mass effect or intraventricular extension with neurological deterioration Day 1 Yes
Secondary Time between arterial puncture and Flow Restoration Day 0 No
Secondary Time between arterial puncture and TICI 2b or 3 recanalization Day 0 No
Secondary Number of SOLITAIRE device runs until recanalization Day 0 No
Secondary Number of patients with and degree of stenosis in the treated artery 90 days after recanalization with SOLITAIRE Day 90 No
Secondary Number of patients in which thrombus material was preserved Day 0 No
Secondary Histological examination of the thrombus material in correlation with TICI 2b or 3 recanalization and favorable clinical outcome Day 1 No
Secondary Overall frequency of modified Rankin Scale 0 to 2 at 30 days Day 30 No

Sponsors