TENSION (Efficacy and safety of ThrombEctomy iN Stroke with extended leSION and extended time window: a randomized, controlled trial) 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. These patiens are currently excluded from available effective treatment approaches.
ESMINT is one of the project partners and is responsible for the Work Package "Dissemination, transfer, scientific data pooling and sharing".
TENSION strives to compare the safety and effectiveness of endovascular thrombectomy as compared to best medical care alone in the treatment of acute ischemic stroke patients with extended stroke lesions defined by an Alberta Stroke Program Early CT Score (ASPECTS) score of 3-5 and in an extended time window (up to 12 hours or unknown time of symptom onset).
Up to 714 subjects will be randomized. Primary endpoint will be functional outcome assessed by the modified Rankin scale at 90 days post-stroke ("mRS shift analysis"). By this, the study aims to provide innovative treatment to patients with severe stroke to reduce the individual and societal burden of death and dependency from stroke.