TECNO is a multicenter, prospective, randomized, open label, blinded endpoint (PROBE) proof-of-concept trial evaluating if additional administration of intra-arterial Tenecteplase (TNK) improves reperfusion in patients with incomplete mechanical thrombectomy (MT). For this purpose, 156 adult participants experiencing an acute ischemic stroke due to a large vessel occlusion with incomplete reperfusion with residual occlusions after MT will be randomly assigned to receive 3mg intra-arterial (IA) TNK or best medical treatment. Recruitment will occur at 20 academic tertiary stroke care centers in Switzerland, Spain, Belgium, and Germany and patients are followed up for 90 days after the index event. Showing superiority for reperfusion outcomes would have a major impact on the future management of stroke patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
156
Patients randomized to IA treatment will receive IA TNK via a standard approved microcatheter positioned as close as possible to the residual occlusion site or as distal as possible in the originating vessel if multiple residual occlusions exists.
LKH-Universitätsklinikum Graz
Graz, Austria
Medizinische Universität Innsbruck
Innsbruck, Austria
Kepler Universitätsklinikum GmbH
Linz, Austria
Christian-Doppler-Klinik Salzburg
Salzburg, Austria
Hôpital universitaires de Bruxelles
Anderlecht, Belgium
AZ Sint Jan Brugge AV
Early reperfusion of the residual intracranial occlusion(s)
Defined by reperfusion improvement on angiography images
Time frame: 25 minutes after randomization
Late reperfusion of the residual intracranial occlusion(s)
Defined by complete reperfusion on perfusion imaging
Time frame: 24 hours ±6 hours
Degree of disability or dependence assessed by the modified ranking scale (mRS) (shift analysis)
mRS
Time frame: 90 days+/-15 days
Normalized change in National Institute of Health Score Scale (NIHSS)
NIHSS
Time frame: 24 hours +/- 6 hours post-randomization
Change in National Institute of Health Score Scale (NIHSS)
NIHSS
Time frame: 90 days +/- 15 days post-randomization
Quality of life as assessed by the EuroQol 5D-3L (EQ-5D-3L)
EuroQol 5D-3L
Time frame: 90 days +/- 15 days
All-cause mortality
Mortality
Time frame: 90 days
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Bruges, Belgium
UZ Brussel
Brussels, Belgium
Cliniques universitaires Saint-Luc
Brussels, Belgium
Universitair Ziekenhuis Gent
Ghent, Belgium
UZ Gasthuisberg Leuven
Leuven, Belgium
...and 42 more locations