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

• Verfasst von: Bendszus, Martin [VerfasserIn]
• Verfasst von: Bonekamp, Susanne [VerfasserIn]
• Titel: A randomized controlled trial to test efficacy and safety of thrombectomy in stroke with extended lesion and extended time window
• Verf.angabe: Martin Bendszus, Susanne Bonekamp, Eivind Berge, Florent Boutitie, Patrick Brouwer, Elke Gizewski, Antonin Krajina, Laurent Pierot, Gary Randall, Claus Z. Simonsen, Kamil Zeleňák, Jens Fiehler and Götz Thomalla
• Jahr: 2019
• Jahr des Originals: 2018
• Umfang: 7 S.
• Fussnoten: First published August 29, 2018 ; Gesehen am 01.08.2019
• Titel Quelle: Enthalten in: International journal of stroke
• Ort Quelle: London : Sage, 2006
• Jahr Quelle: 2019
• Band/Heft Quelle: 14(2019), 1, Seite 87-93
• ISSN Quelle: 1747-4949
• DOI: doi:10.1177/1747493018798558
• Datenträger: Online-Ressource
• Sprache: eng
• K10plus-PPN: 1669411745

Abstract

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 poststroke. The main safety endpoint will be death and dependency (modified Rankin Scale 4?6) at 90 days. Additional effect measures include adverse events, health-related quality of life, poststroke depression, and costs utility assessment.DiscussionTENSION may make effective treatment available for patients with severe stroke in an extended time window, thereby improving functional outcome and quality of life of thousands of stroke patients and reducing the individual, societal, and economic burden of death and disability resulting from severe stroke. TENSION is registered at ClinicalTrials.gov (ClinicalTrials.gov Identifier NCT03094715).