A randomized controlled trial to test efficacy and safety of thrombectomy in stroke with extended lesion and extended time window

RationaleThe benefit of thrombectomy in patients with intracranial large vessel occlusion of the anterior circulation has been shown in selected patients in previous randomized controlled trials, but patients with extended ischemic lesions were excluded in the majority of these trials. TENSION aims to demonstrate efficacy and safety of thrombectomy in patients with extended lesions in an extended time window (up to 12 h from onset or from last seen well).DesignTENSION 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 defined by an Alberta Stroke Program Early Computed Tomography Scan score of 3–5 and in an extended time window. In an adaptive design study, up to 665 patients will be randomized.OutcomesPrimary efficacy endpoint will be clinical outcome defined by the modified Rankin Scale at 90-day...