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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-SC1-2016-2017

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Sub call

H2020-SC1-2017-Two-Stage-RTD

Coordinator

UNIVERSITAETSKLINIKUM HAMBURG-EPPENDORF
Net EU contribution
€ 1 116 079,14
Address
Martinistrasse 52
20251 Hamburg
Germany

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Region
Baden-Württemberg Stuttgart Stuttgart, Stadtkreis
Activity type
Higher or Secondary Education Establishments
Non-EU contribution
€ 0,00

Participants (16)

UNIVERSITATSKLINIKUM HEIDELBERG
Germany
Net EU contribution
€ 2 499 210,65
Address
Im Neuenheimer Feld 672
69120 Heidelberg

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Region
Baden-Württemberg Karlsruhe Heidelberg, Stadtkreis
Activity type
Higher or Secondary Education Establishments
Non-EU contribution
€ 0,00
MEDIZINISCHE UNIVERSITAT INNSBRUCK
Austria
Net EU contribution
€ 142 125,00
Address
Christoph Probst Platz 1
6020 Innsbruck

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Region
Westösterreich Tirol Innsbruck
Activity type
Higher or Secondary Education Establishments
Non-EU contribution
€ 0,00
FAKULTNI NEMOCNICE HRADEC KRALOVE
Czechia
Net EU contribution
€ 60 125,00
Address
Sokolska 581
500 05 Hradec Kralove

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Region
Severovýchod Královéhradecký kraj
Activity type
Research Organisations
Non-EU contribution
€ 0,00
AARHUS UNIVERSITETSHOSPITAL
Denmark
Net EU contribution
€ 212 787,50
Address
Palle Juul-jensens Boulevard 99
8200 Aarhus

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Region
Danmark Midtjylland Østjylland
Activity type
Research Organisations
Non-EU contribution
€ 0,00
CENTRE HOSPITALIER UNIVERSITAIRE DE REIMS
France
Net EU contribution
€ 142 125,00
Address
45 Rue Cognacq Jay
51092 Reims Cedex

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Region
Grand Est Champagne-Ardenne Marne
Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
Non-EU contribution
€ 0,00
OSLO UNIVERSITETSSYKEHUS HF
Norway
Net EU contribution
€ 254 474,61
Address
Kirkeveien 166 Tarnbygget
0450 Oslo

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Region
Norge Oslo og Viken Oslo
Activity type
Higher or Secondary Education Establishments
Non-EU contribution
€ 0,00
REGION STOCKHOLM
Sweden
Net EU contribution
€ 86 047,50
Address
Hantverkargatan 45
104 22 Stockholm

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Region
Östra Sverige Stockholm Stockholms län
Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
Non-EU contribution
€ 0,00
UNIVERZITA KOMENSKEHO V BRATISLAVE
Slovakia
Net EU contribution
€ 117 125,00
Address
Safarikovo Nam 6
814 99 Bratislava

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Region
Slovensko Bratislavský kraj Bratislavský kraj
Activity type
Higher or Secondary Education Establishments
Non-EU contribution
€ 0,00
HOSPICES CIVILS DE LYON
France
Net EU contribution
€ 237 653,75
Address
Quai Des Celestins 3
69002 Lyon

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Region
Auvergne-Rhône-Alpes Rhône-Alpes Rhône
Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
Non-EU contribution
€ 0,00
ECRIN EUROPEAN CLINICAL RESEARCH INFRASTRUCTURE NETWORK
France
Net EU contribution
€ 369 287,81
Address
5 Rue Watt
75013 Paris

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Region
Ile-de-France Ile-de-France Paris
Activity type
Research Organisations
Non-EU contribution
€ 0,00
Third-party

Legal entity other than a subcontractor which is affiliated or legally linked to a participant. The entity carries out work under the conditions laid down in the Grant Agreement, supplies goods or provides services for the action, but did not sign the Grant Agreement. A third party abides by the rules applicable to its related participant under the Grant Agreement with regard to eligibility of costs and control of expenditure.

Masarykova univerzita
Czechia
Net EU contribution
€ 33 587,50
Address
Zerotinovo Namesti 9
601 77 Brno

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SME

The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.

Yes
Region
Jihovýchod Jihomoravský kraj
Activity type
Higher or Secondary Education Establishments
Non-EU contribution
€ 0,00
Third-party

Legal entity other than a subcontractor which is affiliated or legally linked to a participant. The entity carries out work under the conditions laid down in the Grant Agreement, supplies goods or provides services for the action, but did not sign the Grant Agreement. A third party abides by the rules applicable to its related participant under the Grant Agreement with regard to eligibility of costs and control of expenditure.

KKS-NETZWERK EV -NETZWERK DER KOORDINIERUNGSZENTREN FUR KLINISCHE STUDIEN
Germany
Net EU contribution
€ 6 456,04
Address
Alt-moabit 96 A
10559 Berlin

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Region
Berlin Berlin Berlin
Activity type
Research Organisations
Non-EU contribution
€ 0,00
EPPDATA GMBH
Germany
Net EU contribution
€ 464 750,00
Address
Mehlbeerweg 10
22391 Hamburg

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SME

The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.

Yes
Region
Hamburg Hamburg Hamburg
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Non-EU contribution
€ 0,00
EUROPEAN SOCIETY OF MINIMALLY INVASIVE NEUROLOGICAL THERAPY
Switzerland
Net EU contribution
€ 92 100,00
Address
Seefeldstrasse 88
8008 Zurich

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Region
Schweiz/Suisse/Svizzera Zürich Zürich
Activity type
Other
Non-EU contribution
€ 0,00
STROKE ALLIANCE FOR EUROPE
Belgium
Net EU contribution
€ 78 375,00
Address
Rue Washington 40
1050 Brussels

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Region
Région de Bruxelles-Capitale/Brussels Hoofdstedelijk Gewest Région de Bruxelles-Capitale/ Brussels Hoofdstedelijk Gewest Arr. de Bruxelles-Capitale/Arr. Brussel-Hoofdstad
Activity type
Other
Non-EU contribution
€ 0,00
INTERNATIONAL CONSORTIUM FOR HEALTHOUTCOMES MEASUREMENT INC.
United States
Net EU contribution
€ 78 375,00
Address
14 Arrow Street Suite 11
02215 Cambridge Ma

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SME

The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.

Yes
Activity type
Other
Non-EU contribution
€ 0,00