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

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.

Coordinator

UNIVERSITAETSKLINIKUM HAMBURG-EPPENDORF

Address

Martinistrasse 52
20251 Hamburg

Germany

Activity type

Higher or Secondary Education Establishments

EU Contribution

€ 981 718,75

Participants (14)

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UNIVERSITATSKLINIKUM HEIDELBERG

Germany

EU Contribution

€ 2 455 357

MEDIZINISCHE UNIVERSITAT INNSBRUCK

Austria

EU Contribution

€ 142 125

FAKULTNI NEMOCNICE HRADEC KRALOVE

Czechia

EU Contribution

€ 60 125

AARHUS UNIVERSITETSHOSPITAL

Denmark

EU Contribution

€ 212 787,50

CENTRE HOSPITALIER UNIVERSITAIRE DE REIMS

France

EU Contribution

€ 142 125

OSLO UNIVERSITETSSYKEHUS HF

Norway

EU Contribution

€ 394 510

STOCKHOLMS LANS LANDSTING

Sweden

EU Contribution

€ 248 375

UNIVERZITA KOMENSKEHO V BRATISLAVE

Slovakia

EU Contribution

€ 117 125

HOSPICES CIVILS DE LYON

France

EU Contribution

€ 237 653,75

ECRIN EUROPEAN CLINICAL RESEARCH INFRASTRUCTURE NETWORK

France

EU Contribution

€ 285 182,50

EPPDATA GMBH

Germany

EU Contribution

€ 464 750

EUROPEAN SOCIETY OF MINIMALLY INVASIVE NEUROLOGICAL THERAPY

Switzerland

EU Contribution

€ 92 100

STROKE ALLIANCE FOR EUROPE

Belgium

EU Contribution

€ 78 375

INTERNATIONAL CONSORTIUM FOR HEALTHOUTCOMES MEASUREMENT INC.

United States

EU Contribution

€ 78 375

Project information

Grant agreement ID: 754640

Status

Ongoing project

  • Start date

    1 January 2018

  • End date

    31 December 2022

Funded under:

H2020-EU.3.1.3.

  • Overall budget:

    € 5 990 684,50

  • EU contribution

    € 5 990 684,50

Coordinated by:

UNIVERSITAETSKLINIKUM HAMBURG-EPPENDORF

Germany