Efficacy and Safety of Thrombectomy in Stroke With Extended Lesion and Extended Time Window
NCT ID: NCT03094715
Last Updated: 2023-12-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
253 participants
INTERVENTIONAL
2018-06-20
2023-11-15
Brief Summary
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Detailed Description
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Up to 665 subjects will be enrolled in the study and randomized for the Intention to treat analysis set. The randomization will be stratified by time from symptom onset (0-6h and 6-11h/wake up stroke), and stroke severity (NIHSS ≤18, NIHSS \>18).
Interim data analysis is planned after the primary endpoint has been obtained for one third and two thirds of the patients. At each of these sample sizes, the available 90-day mRS data for each treatment arm will be evaluated. Safety interim analysis will be performed after one third and two thirds of the patients have been included.
Subjects who meet the inclusion criteria will be randomized in a 1:1 ratio to one of the following two treatment arms:
Arm 1: best medical care Arm 2: endovascular thrombectomy and best medical care The primary objective of this study is to test efficacy and safety of thrombectomy in acute stroke patients with uncertain benefit of endovascular stroke treatment, i.e. extended ischemic lesion size with an ASPECT score of 3-5 or late (up to 12 hours) or unknown time window as compared to best medical care alone.
Approximately 40 sites in Up to 20 sites in 8-10 European countries Patients presenting with acute ischemic stroke (AIS) based on focal occlusion in the M1 segment of the middle cerebral artery (MCA), and/or the intracranial segment of the distal internal carotid artery (ICA), determined by Magnetic Resonance Angiography (MRA) or Computed Tomographic Angiography (CTA), and who meet all eligibility criteria will be considered for study enrollment.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Thrombectomy
Endovascular thrombectomy and best medical care
Thrombectomy
Mechanical thrombectomy with state of the art thrombectomy devices (i.e. stent-retrievers, aspiration catheters). Devices will be used per instructions for use (IFU).
Best medical care
Best medical treatment
Best medical care
Best medical treatment will be performed as detailed in established Standard Operating Procedures, following regional guidelines (American Heart Association (AHA), European Stroke Organisation (ESO), Deutsche Schlaganfall-Gesellschaft (DSG), local country, etc.). If applicable, the reason for iv tissue plasminogen activator (tPA) ineligibility has to be documented on the eCRF.
Interventions
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Thrombectomy
Mechanical thrombectomy with state of the art thrombectomy devices (i.e. stent-retrievers, aspiration catheters). Devices will be used per instructions for use (IFU).
Best medical care
Best medical treatment will be performed as detailed in established Standard Operating Procedures, following regional guidelines (American Heart Association (AHA), European Stroke Organisation (ESO), Deutsche Schlaganfall-Gesellschaft (DSG), local country, etc.). If applicable, the reason for iv tissue plasminogen activator (tPA) ineligibility has to be documented on the eCRF.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Endovascular treatment is expected to be finished within 12 hours after known symptom onset or last seen well by judgment of the interventional neuroradiologist in charge (if stroke onset is known).
* Patient must demonstrate clinical signs and symptoms attributable to target area of occlusion consistent with the diagnosis of ischemic stroke, including impairment of the following: language, motor function, sensation, cognition, gaze, and/or vision for at least 30 minutes without relevant improvement.
* Female and male patient above 18 years of age
* NIHSS Score of \<26
* Signed informed consent (IC) form by patient or legal guardian, or inclusion of patient's presumptive will by investigator under emergency situation, but after consultation of an independent physician who is familiar with these types of illness if the other options are not possible according to local approval.
* Prior to new focal neurological deficit, mRS score was ≤2.
* A new focal occlusion confirmed by imaging (MRA/CTA) to be accessible to the thrombectomy device, and located in the M1 of the middle cerebral artery (MCA) and/or the intracranial segment of the distal internal carotid artery (ICA).
* CT (non-contrast CT) or DWI with an ASPECT score of 3-5
Exclusion Criteria
* Patient has pre-existing neurological or psychiatric disease that could impede the study results or would confound the neurological or functional evaluations.
* Patient has vascular disease preventing endovascular treatment (e.g. aortic dissection or aneurysm, no arterial transfemoral access)
* Patient has history of contraindication for contrast medium.
* Patient is known to have infective endocarditis
* Patient's anticipated life expectancy is less than 6 Months12 months
* ExtracaranialExtracranial CT scan or MR angiography showing high grade stenosis expected to require acute stent placement (especially e.g. ICAACI stenting) during the procedure to get access to the occlusion
* CT or MRI with evidence of: Mass mass effect or intracranial tumor, or hypodensity on unenhanced CT and
* If CT perfusion is done per institutional standard: CBV drop on CBV maps on CTP, or, alternatively as with an ASPECT score of 0-2
* If DWI is done per institutional standard,: restricted diffusion on DWI with an ASPECT score of 0-2, or above 5
18 Years
ALL
No
Sponsors
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Karolinska University Hospital
OTHER
Eppdata GmbH Hamburg, Germany
UNKNOWN
Aarhus University Hospital
OTHER
Medical University Innsbruck
OTHER
Groupe Hospitalier Pitie-Salpetriere
OTHER
Oslo University Hospital
OTHER
University Hospital, Martin
OTHER
Charles University, Czech Republic
OTHER
Hospices Civils de Lyon
OTHER
CHU de Reims
OTHER
Epidemiological and Clinical Research Information Network
OTHER
STROKE ALLIANCE FOR EUROPE
UNKNOWN
International Consortium for Health Outcome Measurement, Inc.
OTHER
Europan Society for Minimally Invasive Neurological Therapy
UNKNOWN
Universitätsklinikum Hamburg-Eppendorf
OTHER
University Hospital Heidelberg
OTHER
Responsible Party
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Martin Bendszus
Central trial management, Coordinating investigator
Principal Investigators
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Götz Thomalla, MD
Role: STUDY_CHAIR
Coordination and Project Management Tension, Neurology, UKE Hamburg, Germany
Martin Bendszus, MD
Role: PRINCIPAL_INVESTIGATOR
Central Trial Management Tension, Neuroradiology, UHHeidelberg, Germany
Locations
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Division of Neuroradiology, Vascular and Interventional Radiology, Department of Radiology, Medical University Graz
Graz, , Austria
Medical University Innsbruck
Innsbruck, , Austria
Neuroradiology, Keppler University Hospital Linz
Linz, , Austria
Department of Neurology, Reseach Institute of Neurointervention, Christian Doppler Clinic, Paracelsus Medical University Salzburg
Salzburg, , Austria
University of Calgary
Calgary, Alberta, Canada
St. Anne's University Hospital Brno
Brno, , Czechia
Faculty Hospital Hradec Kralove
Hradec Králové, , Czechia
Comprehensive stroke center,University Hospital Ostrava
Ostrava, , Czechia
Homolka Hospital Prague
Prague, , Czechia
Dept. of Radiology, Masaryk hospital
Ústí nad Labem, , Czechia
Aalborg University Hospital
Aalborg, , Denmark
Aarhus University Hospital
Aarhus, , Denmark
University Hospital Rigshospitalet
Copenhagen, , Denmark
CHU Gabriel Montpied, Clermont-Ferrand
Clermont-Ferrand, , France
Hôpiteaux Universitaires Paris-Sud, Hôpital Bicêtre
Le Kremlin-Bicêtre, , France
Hôpital Pitié-Salpêtrière
Paris, , France
Université Reims Champagne Ardenne/ Department of Neuroradiology, Hôpital Maison Blanche
Reims, , France
CHU de Rennes/Centre Urgences-Réanimations
Rennes, , France
CHRU Hôpiteaux de Tours / Hôpital Bretonneau
Tours, , France
Universitätsinstitut für Diagnostische Radiologie, Neuroradiologie und Nuklearmedizin Johannes Wesling Klinikum Minden
Minden, North Rhine-Westphalia, Germany
Otto-von-Guericke-University Magdeburg
Magdeburg, Saxony-Anhalt, Germany
Universitätsklinikum KK Bochum-Langendreer Institut für Diagnostische und Interventionelle Radiologie, Neuroradiologie und Nuklearmedizin
Bochum, , Germany
Universitätsklinikum Bonn
Bonn, , Germany
Gesundheit Nord gGmbH Klinikverbund Bremen
Bremen, , Germany
Klinik für Radiologie und Neuroradiologie am Klinikum Mitte
Dortmund, , Germany
Universitätsklinikum Carl Gustav Carus Dresden
Dresden, , Germany
Alfried Krupp Krankenhaus Rüttenscheid
Essen, , Germany
Diakonissenkrankenhaus Flensburg
Flensburg, , Germany
Universitätsklinikum Hamburg-Eppendorf
Hamburg, , Germany
Neuroradiologie Universitätsklinikum Heidelberg
Heidelberg, , Germany
Universitätsklinikum Leipzig AöR
Leipzig, , Germany
UKSH Universitätsklinikum Schleswig-Holstein Campus Lübeck
Lübeck, , Germany
Klinikum der Universität München
München, , Germany
Technische Universität München / Klinikum rechts der Isar
München, , Germany
Universitätsklinikum Würzburg
Würzburg, , Germany
Haukeland University Hospital
Bergen, , Norway
Oslo University Hospital
Oslo, , Norway
The Arctic University of Norway
Tromsø, , Norway
Comenius University's Jessenius Faculty of Medicine and University Hospital
Martin, , Slovakia
Faculty Hospital Trnava
Trnava, , Slovakia
La Paz University Hospital
Madrid, , Spain
University Hospital Basel
Basel, , Switzerland
Countries
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References
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Bendszus M, Bonekamp S, Berge E, Boutitie F, Brouwer P, Gizewski E, Krajina A, Pierot L, Randall G, Simonsen CZ, Zelenak K, Fiehler J, Thomalla G. A randomized controlled trial to test efficacy and safety of thrombectomy in stroke with extended lesion and extended time window. Int J Stroke. 2019 Jan;14(1):87-93. doi: 10.1177/1747493018798558. Epub 2018 Aug 29.
Bendszus M, Fiehler J, Subtil F, Bonekamp S, Aamodt AH, Fuentes B, Gizewski ER, Hill MD, Krajina A, Pierot L, Simonsen CZ, Zelenak K, Blauenfeldt RA, Cheng B, Denis A, Deutschmann H, Dorn F, Flottmann F, Gellissen S, Gerber JC, Goyal M, Haring J, Herweh C, Hopf-Jensen S, Hua VT, Jensen M, Kastrup A, Keil CF, Klepanec A, Kurca E, Mikkelsen R, Mohlenbruch M, Muller-Hulsbeck S, Munnich N, Pagano P, Papanagiotou P, Petzold GC, Pham M, Puetz V, Raupach J, Reimann G, Ringleb PA, Schell M, Schlemm E, Schonenberger S, Tennoe B, Ulfert C, Valis K, Vitkova E, Vollherbst DF, Wick W, Thomalla G; TENSION Investigators. Endovascular thrombectomy for acute ischaemic stroke with established large infarct: multicentre, open-label, randomised trial. Lancet. 2023 Nov 11;402(10414):1753-1763. doi: 10.1016/S0140-6736(23)02032-9. Epub 2023 Oct 11.
van Horn N, Kniep H, Broocks G, Meyer L, Flottmann F, Bechstein M, Gotz J, Thomalla G, Bendszus M, Bonekamp S, Pfaff JAR, Dellani PR, Fiehler J, Hanning U. ASPECTS Interobserver Agreement of 100 Investigators from the TENSION Study. Clin Neuroradiol. 2021 Dec;31(4):1093-1100. doi: 10.1007/s00062-020-00988-x. Epub 2021 Jan 27.
Winkelmeier L, Kniep H, Thomalla G, Bendszus M, Subtil F, Bonekamp S, Aamodt AH, Fuentes B, Gizewski ER, Hill MD, Krajina A, Pierot L, Simonsen CZ, Zelenak K, Blauenfeldt RA, Cheng B, Denis A, Deutschmann H, Dorn F, Gellissen S, Gerber JC, Goyal M, Haring J, Herweh C, Hopf-Jensen S, Hua VT, Jensen M, Kastrup A, Keil CF, Klepanec A, Kurca E, Mikkelsen R, Mohlenbruch M, Muller-Hulsbeck S, Munnich N, Pagano P, Papanagiotou P, Petzold GC, Pham M, Puetz V, Raupach J, Reimann G, Ringleb PA, Schell M, Schlemm E, Schonenberger S, Tennoe B, Ulfert C, Valis K, Vitkova E, Vollherbst DF, Wick W, Fiehler J, Flottmann F; TENSION Investigators. Arterial Collaterals and Endovascular Treatment Effect in Acute Ischemic Stroke with Large Infarct: A Secondary Analysis of the TENSION Trial. Radiology. 2025 Feb;314(2):e242401. doi: 10.1148/radiol.242401.
Thomalla G, Fiehler J, Subtil F, Bonekamp S, Aamodt AH, Fuentes B, Gizewski ER, Hill MD, Krajina A, Pierot L, Simonsen CZ, Zelenak K, Blauenfeldt RA, Cheng B, Denis A, Deutschmann H, Dorn F, Flottmann F, Gellissen S, Gerber JC, Goyal M, Haring J, Herweh C, Hopf-Jensen S, Hua VT, Jensen M, Kastrup A, Keil CF, Klepanec A, Kurca E, Mikkelsen R, Mohlenbruch M, Muller-Hulsbeck S, Munnich N, Pagano P, Papanagiotou P, Petzold GC, Pham M, Puetz V, Raupach J, Reimann G, Ringleb PA, Schell M, Schlemm E, Schonenberger S, Tennoe B, Ulfert C, Valis K, Vitkova E, Vollherbst DF, Wick W, Bendszus M; TENSION Investigators. Endovascular thrombectomy for acute ischaemic stroke with established large infarct (TENSION): 12-month outcomes of a multicentre, open-label, randomised trial. Lancet Neurol. 2024 Sep;23(9):883-892. doi: 10.1016/S1474-4422(24)00278-3. Epub 2024 Jul 26.
Roaldsen MB, Jusufovic M, Berge E, Lindekleiv H. Endovascular thrombectomy and intra-arterial interventions for acute ischaemic stroke. Cochrane Database Syst Rev. 2021 Jun 14;6(6):CD007574. doi: 10.1002/14651858.CD007574.pub3.
Other Identifiers
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TENSION
Identifier Type: -
Identifier Source: org_study_id