Acute Stroke
Conditions
Keywords
stroke, mechanical recanalization, self-expanding stent, Solitaire
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 SOLITAIR is a safe and feasible method for interventional recanalization of large vessels with favorable patient outcome in acute stroke therapy.
Interventions
DEVICESolitaire FR, ev3
Placement of the stent in the occluded vessel segment, withdrawal in its unfolded state.
Sponsors
Universität des Saarlandes
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | 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 |
| Number of SOLITAIRE device runs until recanalization | Day 0 |
| Time between arterial puncture and TICI 2b or 3 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 |
| Time between arterial puncture and Flow Restoration | Day 0 |
Countries
Germany
Outcome results
None listed