Status:
COMPLETED
Mechanical Recanalization With Flow Restoration in Acute Ischemic Stroke
Lead Sponsor:
Universität des Saarlandes
Conditions:
Acute Stroke
Eligibility:
All Genders
18-85 years
Phase:
PHASE2
Brief Summary
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 S...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2011
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01210729
Start Date
September 1 2010
End Date
November 1 2011
Last Update
December 2 2011
Active Locations (1)
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1
Department of diagnostic and interventional Neuroradiology
Homburg, Saarland, Germany, 66424