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

International Journal of Stroke : Official Journal of the International Stroke Society
Martin BendszusGötz Thomalla

Abstract

The 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). 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 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. Primary 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. TENSI...Continue Reading

References

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Citations

Sep 20, 2018·Journal of Neuroimaging : Official Journal of the American Society of Neuroimaging·Marta Olive-GadeaMarta Rubiera
Feb 15, 2019·Clinical Neuroradiology·Martin BendszusGötz Thomalla
Jul 25, 2019·Stroke; a Journal of Cerebral Circulation·Frank A WollenweberJens Fiehler
Aug 21, 2019·Stroke; a Journal of Cerebral Circulation·David S LiebeskindEdward C Jauch
Jul 6, 2019·Journal of Neurointerventional Surgery·Arturo Renú JornetAngel Chamorro
Jul 29, 2019·Journal of Neurointerventional Surgery·Jan Christoph PurruckerChristoph Gumbinger
Aug 21, 2019·Journal of Neurointerventional Surgery·Wagih Ben HassenHilde Henon
Apr 18, 2020·The Canadian Journal of Neurological Sciences. Le Journal Canadien Des Sciences Neurologiques·Jose Danilo B DiestroAditya Bharatha
Jul 21, 2020·Expert Review of Cardiovascular Therapy·Ankur WadhwaBijoy Menon
Jun 7, 2019·Brain : a Journal of Neurology·Gabriel BroocksAndre Kemmling
Feb 8, 2020·Clinical Neuroradiology·Jens FiehlerMartin Bendszus
Jun 9, 2020·Practical Neurology·Robert HurfordKeith W Muir
Sep 16, 2020·Journal of Neurointerventional Surgery·Johanna Maria OspelUNKNOWN HERMES collaborators
Sep 12, 2020·Clinical Neuroradiology·Mayank GoyalJohanna Maria Ospel
Feb 29, 2020·Journal of Neurointerventional Surgery·Milani Deb-ChatterjiUNKNOWN GSR-ET Investigators
Jan 28, 2021·Clinical Neuroradiology·Noel van HornUta Hanning
Dec 17, 2020·Neurological Research and Practice·Christian Grefkes, Gereon R Fink
Nov 15, 2020·Journal of Neurointerventional Surgery·Amrou SarrajUNKNOWN SELECT Investigators
Jan 10, 2021·Journal of Neuroimaging : Official Journal of the American Society of Neuroimaging·Maximilian T LöfflerJan S Kirschke
Apr 3, 2021·Therapeutic Advances in Neurological Disorders·Peter B SpornsMarios Psychogios
Apr 28, 2021·Neuroimaging Clinics of North America·Benjamin PulliMax Wintermark
Jun 4, 2021·Stroke; a Journal of Cerebral Circulation·Mikael Mazighi, Götz Thomalla
Sep 3, 2021·Stroke; a Journal of Cerebral Circulation·Lukas MeyerUNKNOWN German Stroke Registry–Endovascular Treatment (GSR-ET)

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Methods Mentioned

BETA
dissection

Clinical Trials Mentioned

NCT03094715

Software Mentioned

MR CLEAN
ASPECTS
EuroQol
TENSION

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