To determine the revascularization rate of the CE-marked Trevo device in large vessel occlusions in ischemic stroke patients. * Revascularization, defined as at least TICI 2a in the vascular territory treated at end of the neuro interventional procedure.
* Clinical outcomes at 90 days * Mortality at 90 days * Device-related serious adverse events (DRSAEs) * Symptomatic ICH rate within 24 (-6/+12) hours post-procedure
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
The Trevo device is intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke.
Christian Doppler Clinic
Salzburg, Austria
Universitätsklinik Göttingen
Göttingen, Germany
University Hospital Schleswig-Holstein Campus Kiel
Kiel, Germany
Technische Universität München
Munich, Germany
Revascularization Status
Revascularization, defined as at least TICI 2a in the vascular territory treated at end of the neuro interventional procedure Thrombolysis in Cerebral Infarction (TICI) grading system for perfusion (ie blood flow through a vessel) Grade 0:No Perfusion. No antegrade flow beyond the point of occlusion. Grade 1:Penetration With Minimal Perfusion. Grade 2:Partial Perfusion. Grade 2a:Only partial filling (\<2/3) of the entire vascular territory is visualized. Grade 2b:Complete filling of all of the expected vascular territory is visualized, but slower ... Grade 3:Complete Perfusion. For complete info see Higashida RT, Furlan AJ, Roberts H, Tomsick T, Connors B et al. (2003) Trial design and reporting standards for intra-arterial cerebral thrombolysis for acute ischemic stroke. Stroke 34: e109-e137.10.1161/01.STR.0000082721.62796.09 PubMed: 12869717\[PubMed\]
Time frame: Post-procedure, immediate=at the end of the procedure, per last angiogram during treatment
Clinical Outcomes at 90 Days
Good clinical outcome is defined as an modified Rankin Scale (mRS) score of 0-2 at 90 days. mRS 0-2 indicates functional independence 0 - No symptoms. 1. \- No significant disability. Able to carry out all usual activities, despite some symptoms. 2. \- Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. 3. \- Moderate disability. Requires some help, but able to walk unassisted. 4. \- Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. 5. \- Severe disability. Requires constant nursing care and attention, bedridden, incontinent. 6. \- Dead. https://en.wikipedia.org/wiki/Modified\_Rankin\_Scale
Time frame: 90-day
Mortality at 90 Days
All cause mortality through 90 days post procedure.
Time frame: 90-day
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Hospital Clínic de Barcelona
Barcelona, Spain
Hospital Universitari Germans Trias i Pujols
Barcelona, Spain
Karolinska University Hospital
Stockholm, Sweden