Multi-center, randomized, parallel-group, superiority study to compare the efficacy of adjunct intra-arterial rt-PA versus not adjunct intra-arterial rt-PA in the improvement of the efficacy of mechanical thrombectomy in patients with large vessel occlusion acute ischemic stroke.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
440
See arm/group descriptions.
Hospital Universitario de A Coruña
A Coruña, Spain, Spain
Hospital Universitario Dr. Balmis
Alicante, Spain, Spain
Hospital Germans Trías i Pujol
Badalona, Spain, Spain
Modified Rankin Scale at day 90
Proportion of patients with Modified Rankin Scale 0 or 1 at day 90 +/- 15d
Time frame: 90 days post treatment
Microvascular hypoperfusion on follow-up brain CTP
Proportion of patients with abnormal microvascular hypoperfusion on CT Perfusion
Time frame: 36±24hours post treatment
Volume of hypoperfusion on brain CTP
Volume of hypoperfusion on brain CTP
Time frame: at 36h±24h post treatment
Infarct Expansion Ratio (IER): Final infarct to initial ischemic tissue volumes on brain CTP
Infarct Expansion Ratio (IER): Final infarct to initial ischemic tissue volumes on brain CTP at 36±24hours post MT.
Time frame: 36±24hours post treatment
Barthel Scale score
Barthel Scale score of 95 to 100, (min value 0, max value 100, higher score better outcome)
Time frame: day 90 post treatment
EuroQol Group 5-Dimension Self-Report Questionnaire (EQ-5D-3L)
Quality of life measured with the EuroQol Group 5-Dimension Self-Report Questionnaire (EQ-5D-3L) The score has five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems.
Time frame: day 90 post treatment
Shift analysis of the modified Rankin Scale (mRS)
Shift analysis of the modified Rankin Scale (mRS), at day 90 (min value 0, max value 6, higher score worse outcome)
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Hospital Clinic Barcelona
Barcelona, Spain, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain, Spain
Hospital Universitario de Cruces
Bilbao, Spain, Spain
Hospital Josep Trueta
Girona, Spain, Spain
Hospital Universitario Virgen de la Arrixaca
Murcia, Spain, Spain
Hospital Universitario Central de Asturias
Oviedo, Spain, Spain
Hospital Universitario Son Espases
Palma de Mallorca, Spain, Spain
...and 4 more locations
Time frame: day 90 post treatment