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Efficacy and safety of thrombectomy in stroke with extended lesion and extended time window: a randomized, controlled trial

Objective

TENSION (efficacy and safety of ThrombEctomy iN Stroke with extended leSION and extended time window: a randomized, controlled trial) strives at providing innovative treatment to patients with severe stroke to reduce the individual and societal burden of death and dependency from stroke. To this end, TENSION is a randomized, controlled, prospective, open label, blinded endpoint (PROBE) trial of thrombectomy in stroke patients with extended ischemic stroke lesions and patients presenting in a late time window, who are currently excluded from available effective treatment approaches. The trial will enroll up to 714 subjects in eight European countries. The primary endpoint is functional outcome at 90 days post-stroke measured by the Modified Rankin Scale. The primary effectiveness endpoint analysis is a chi-square test of the difference in linear trends in ordinal mRS outcomes between treatment groups (“mRS shift analysis”). Outcome evaluation will involve a comprehensive array of clinical and safety parameters, health and socio-economic outcomes including patient reported outcome measures (PROM) for evaluation according to the principles of value-based healthcare. Health economic evaluation with cost-effectiveness analysis will be performed and gender-effects on treatment and outcome will be studied. Trial organization will rely on a network of experienced partners with successful cooperation in previous EU-funded stroke trials. An image core lab will provide central judgement of all images acquired within the trial. Standards of image judgement and intervention will be defined and trial specific training will be provided to all investigators. TENSION addresses a major health problem and will provide evidence for more effective and safer therapeutic intervention for patients with severe stroke resulting in improved guideline development, better individual patient outcomes and beneficial effects for the society at large by reduction of stroke-related costs.

Call for proposal

H2020-SC1-2017-Two-Stage-RTD
See other projects for this call

Coordinator

UNIVERSITAETSKLINIKUM HAMBURG-EPPENDORF
Address
Martinistrasse 52
20251 Hamburg
Germany
Activity type
Higher or Secondary Education Establishments
EU contribution
€ 1 116 079,14

Participants (14)

UNIVERSITATSKLINIKUM HEIDELBERG
Germany
EU contribution
€ 2 499 210,65
Address
Im Neuenheimer Feld 672
69120 Heidelberg
Activity type
Higher or Secondary Education Establishments
MEDIZINISCHE UNIVERSITAT INNSBRUCK
Austria
EU contribution
€ 142 125
Address
Christoph Probst Platz 1
6020 Innsbruck
Activity type
Higher or Secondary Education Establishments
FAKULTNI NEMOCNICE HRADEC KRALOVE
Czechia
EU contribution
€ 60 125
Address
Sokolska 581
500 05 Hradec Kralove
Activity type
Research Organisations
AARHUS UNIVERSITETSHOSPITAL
Denmark
EU contribution
€ 212 787,50
Address
Palle Juul-jensens Boulevard 99
8200 Aarhus
Activity type
Research Organisations
CENTRE HOSPITALIER UNIVERSITAIRE DE REIMS
France
EU contribution
€ 142 125
Address
45 Rue Cognacq Jay
51092 Reims Cedex
Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
OSLO UNIVERSITETSSYKEHUS HF
Norway
EU contribution
€ 254 474,61
Address
Kirkeveien 166 Tarnbygget
0450 Oslo
Activity type
Higher or Secondary Education Establishments
REGION STOCKHOLM
Sweden
EU contribution
€ 86 047,50
Address
Hantverkargatan 45
104 22 Stockholm
Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
UNIVERZITA KOMENSKEHO V BRATISLAVE
Slovakia
EU contribution
€ 117 125
Address
Safarikovo Nam 6
814 99 Bratislava
Activity type
Higher or Secondary Education Establishments
HOSPICES CIVILS DE LYON
France
EU contribution
€ 237 653,75
Address
Quai Des Celestins 3
69002 Lyon
Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
ECRIN EUROPEAN CLINICAL RESEARCH INFRASTRUCTURE NETWORK
France
EU contribution
€ 409 331,35
Address
5 Rue Watt
75013 Paris
Activity type
Research Organisations
EPPDATA GMBH
Germany
EU contribution
€ 464 750
Address
Mehlbeerweg 10
22391 Hamburg
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
EUROPEAN SOCIETY OF MINIMALLY INVASIVE NEUROLOGICAL THERAPY
Switzerland
EU contribution
€ 92 100
Address
Seefeldstrasse 88
8008 Zurich
Activity type
Other
STROKE ALLIANCE FOR EUROPE
Belgium
EU contribution
€ 78 375
Address
Rue Washington 40
1050 Brussels
Activity type
Other
INTERNATIONAL CONSORTIUM FOR HEALTHOUTCOMES MEASUREMENT INC.
United States
EU contribution
€ 78 375
Address
14 Arrow Street Suite 11
02215 Cambridge Ma
Activity type
Other