Efficacy and Safety of Thrombectomy in Stroke With Extended Lesion and Extended Time Window
TENSION is an investigator-initiated, randomized controlled, open label, blinded endpoint, European, two-arm, postmarket study to compare the safety and effectiveness of thrombectomy as compared to best medical care alone in stroke patients with extended stroke lesions. Patients are eligible, of they present with an Alberta Stroke Program Early Computed Tomography Scan score of 3–5. In an adaptive design study, up to 665 patients will be randomized. The primary endpoint is functional outcome at 90 days post-stroke measured by the Modified Rankin Scale.
The vision of TENSION is to reduce the burden of death and disability from stroke by providing innovative effective treatment to severe stroke patients for whom currently no effective treatment is available.
TENSION receives funding by the European Union’s Horizon 2020 research and innovation programme.
ClinicalTrials.gov Identifier, NCT03094715