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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Best Medical Treatment (standard of care) | No Intervention | Patients will receive standard of care as per current ESO guidelines. | |
| Intra-arterial Tenecteplase | Experimental | Patients will receive intra-arterial administration of Tenecteplase using a standard approved microcatheter. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tenecteplase | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Early reperfusion of the residual intracranial occlusion(s) | Defined by reperfusion improvement on angiography images | 25 minutes after randomization |
| Late reperfusion of the residual intracranial occlusion(s) | Defined by complete reperfusion on perfusion imaging | 24 hours ±6 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Degree of disability or dependence assessed by the modified ranking scale (mRS) (shift analysis) | mRS | 90 days+/-15 days |
| Normalized change in National Institute of Health Score Scale (NIHSS) | NIHSS |
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Inclusion Criteria
Informed consent
Age ≥18 years
Clinical signs consistent with an acute ischemic stroke
Patient had an initial vessel occlusion in the anterior or posterior circulation defined as intracranial ICA, M1, M2, M3, A1, A2, P1 or P2
Patient has undergone endovascular stroke treatment
Onset to randomization no later than < 705 minutes (11h 45min) after symptom-onset/last-seen well.
Incomplete reperfusion defined as any of the following:
Signs of early ischemic changes of non-contrast CT Alberta Stroke Program Early CT Score (ASPECTS) ≥5 (for DWI-ASPECTS ≥ 4, for DWI-ASECTS: a region must have diffusion abnormality in 20% or more of its volume to be considered DWI-ASPECTS positive)
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Urs Fischer, PhD | NCTU | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| LKH-Universitätsklinikum Graz | Graz | 8036 | Austria | |||
| Medizinische Universität Innsbruck |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39567366 | Derived | Mujanovic A, Windecker D, Cimflova P, Meinel TR, Seiffge DJ, Auer E, Boulouis G, Arnold M, Serrallach BL, Rohner R, Janot K, Dobrocky T, Hill MD, Goyal M, Piechowiak EI, Gralla J, Fischer U, Kaesmacher J. Natural Evolution of Incomplete Reperfusion in Patients Following Endovascular Therapy After Ischemic Stroke. Stroke. 2025 Feb;56(2):447-455. doi: 10.1161/STROKEAHA.124.049641. Epub 2024 Nov 20. |
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Parallel Assignment
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| 24 hours +/- 6 hours post-randomization |
| Change in National Institute of Health Score Scale (NIHSS) | NIHSS | 90 days +/- 15 days post-randomization |
| Quality of life as assessed by the EuroQol 5D-3L (EQ-5D-3L) | EuroQol 5D-3L | 90 days +/- 15 days |
| All-cause mortality | Mortality | 90 days |
| Innsbruck |
| 6020 |
| Austria |
| Kepler Universitätsklinikum GmbH | Linz | 4020 | Austria |
| Christian-Doppler-Klinik Salzburg | Salzburg | 5020 | Austria |
| Hôpital universitaires de Bruxelles | Anderlecht | 1070 | Belgium |
| AZ Sint Jan Brugge AV | Bruges | 8000 | Belgium |
| UZ Brussel | Brussels | 1050 | Belgium |
| Cliniques universitaires Saint-Luc | Brussels | 1200 | Belgium |
| Universitair Ziekenhuis Gent | Ghent | 9000 | Belgium |
| UZ Gasthuisberg Leuven | Leuven | 3000 | Belgium |
| Clinique CHC MontLégia | Liège | 4000 | Belgium |
| University Hospital Helsinki | Helsinki | 00029 | Finland |
| Universitätsklinikum Augsburg | Augsburg | 86156 | Germany |
| Universitätsklinikum Bonn | Bonn | 53127 | Germany |
| Klinikum Bremen-Mitte | Bremen | 28205 | Germany |
| Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden | Dresden | 01307 | Germany |
| Helios Klinikum Erfurt | Erfurt | 99089 | Germany |
| Universitätsklinikum Frankfurt | Frankfurt | 60528 | Germany |
| Universitätsklinikum Freiburg | Freiburg im Breisgau | 79106 | Germany |
| Universitätsmedizin Göttingen | Göttingen | 37075 | Germany |
| Universitätsklinikum Halle (Saale) | Halle | 06120 | Germany |
| Universitätsklinikum Hamburg-Eppendorf | Hamburg | 20246 | Germany |
| Asklepios Klinik Altona | Hamburg | 22763 | Germany |
| Universitätsklinikum Schleswig-Holstein Campus Kiel | Kiel | 24105 | Germany |
| Universitätsklinikum Magdeburg A. ö. R. | Magdeburg | 39120 | Germany |
| Universitätsmedizin Mannheim | Mannheim | 68167 | Germany |
| Johannes Wesling Klinikum Minden | Minden | 32429 | Germany |
| Klinikum der Universität München | München | 81377 | Germany |
| Klinikum rechts der Isar der Technischen Universität München | München | 81675 | Germany |
| Universitätsklinikum Münster | Münster | 48149 | Germany |
| Städtisches Klinikum Sollingen | Solingen | 42653 | Germany |
| Universitätsklinikum Tübingen | Tübingen | 72076 | Germany |
| Amsterdam UMC | Amsterdam | 1100 | Netherlands |
| Leiden UMC | Leiden | 2300 | Netherlands |
| Hospital de Braga | Braga | 4710-243 | Portugal |
| Hospital Nelio Mendonca Funchal | Funchal | 9000-177 | Portugal |
| Lisbon Central University Hospital | Lisbon | 1150-199 | Portugal |
| Hospital Eagas Moniz | Lisbon | 1349-019 | Portugal |
| Hospital Santo Antonio | Porto | 4099-001 | Portugal |
| Kantonsspital Aarau AG | Aarau | 5001 | Switzerland |
| Kantonsspital Aarau | Aarau | 5001 | Switzerland |
| Kantonsspital Aarau | Aarau | Switzerland |
| Universitätsspital Basel | Basel | Switzerland |
| Universitätsspital Bern | Bern | 3010 | Switzerland |
| Hôpitaux universitaires de Genève | Geneva | 1211 | Switzerland |
| Centre Hospitalier Universitaire Vaudois (CHUV) | Lausanne | 1011 | Switzerland |
| Centre Hospitalier Universitaire Vaudois | Lausanne | 1011 | Switzerland |
| University Hospital of Lausanne | Lausanne | Switzerland |
| Kantonsspital Luzern | Lucerne | 6000 | Switzerland |
| Ospedale Regionale di Lugano | Lugano | 6900 | Switzerland |
| Kantonsspital St.Gallen | Sankt Gallen | 9007 | Switzerland |
| Universitätsspital Zürich | Zurich | 8091 | Switzerland |
| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000077785 | Tenecteplase |
| ID | Term |
|---|---|
| D010959 | Tissue Plasminogen Activator |
| D012697 | Serine Endopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D057057 | Serine Proteases |
| D010960 | Plasminogen Activators |
| D001779 | Blood Coagulation Factors |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
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