Mechanical Recanalization With Flow Restoration in Acute Ischemic Stroke

Study Overview
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Brief Summary
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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.

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

Conditions
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Acute Stroke

Intervention / Treatment
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* Device: Solitaire FR, ev3


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Solitaire FR, ev3|Placement of the stent in the occluded vessel segment, withdrawal in its unfolded state.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Excellent functional clinical outcome (modified Rankin Scale 0 or 1) |  | Day 90 | 
| All causes of mortality |  | Day 90 | 
| Proportion of patients with rapid neurological improvement (more than 4 points on the NIHSS) during the first 24 hours after treatment. |  | Day 1 | 
| 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 | 
| Time between arterial puncture and Flow Restoration |  | Day 0 | 
| Time between arterial puncture and TICI 2b or 3 recanalization |  | Day 0 | 
| Number of SOLITAIRE device runs until recanalization |  | Day 0 | 
| Number of patients with and degree of stenosis in the treated artery 90 days after recanalization with SOLITAIRE |  | Day 90 | 
| Number of patients in which thrombus material was preserved |  | Day 0 | 
| Histological examination of the thrombus material in correlation with TICI 2b or 3 recanalization and favorable clinical outcome |  | Day 1 | 
| Overall frequency of modified Rankin Scale 0 to 2 at 30 days |  | Day 30 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stroke, mechanical recanalization, self-expanding stent, Solitaire