Mechanical Recanalization With Flow Restoration in Acute Ischemic Stroke

Mechanical Recanalization With Flow Restoration in Acute Ischemic Stroke (ReFlow Study)

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.

Inclusion Criteria:

• Age 18-85 years
• Acute ischemic stroke with occlusion if ICA, MCA, VA or BA (TICI 0 or 1 flow) within the first 6 hours

Exclusion Criteria:

• Rapidly improving neurological signs
• NHISS>30 or coma
• Female patients, who are pregnant or lactating
• Use of warfarin anticoagulation with INR > 1.5
• Platelet count < 30,000
• Glucose < 50 mg/dL
• Life expectancy of less than 90 days
• Computed tomography (CT) or Magnetic Resonance Imaging (MRI) evidence of hemorrhage on presentation
• CT showing hypodensity on presentation