Efficacy and Safety of Thrombectomy in Stroke With Extended Lesion and Extended Time Window

NCT03094715 | Terminated DMC FDA Device

• 1 other identifier: TENSION
• Study Type: interventional
• Target: 253
• Locations: 10 countries
• Sites: 42

Brief Summary

TENSION (Efficacy and safety of ThrombEctomy iN Stroke with extended leSION and extended time window) is a prospective, open label, blinded endpoint (PROBE), European two-arm, randomized, controlled, post-market study to compare the safety and effectiveness of endovascular thrombectomy as compared to best medical care alone in the treatment of acute ischemic stroke patients with extended stroke lesions defined by an Alberta Stroke Program Early CT Score (ASPECTS) score of 3-5 and in an extended time window (up to 12 hours or unknown time of symptom onset). Up to 665 subjects will be randomized. Primary endpoint will be functional outcome assessed by the modified Rankin scale at 90 days post-stroke ("mRS shift analysis"). By this, TENSION will provide evidence of efficacy and safety of thrombectomy in an acute stroke population with uncertain benefit of endovascular stroke treatment.

Conditions

Stroke, Acute; Cerebral Stroke; Cerebrovascular Stroke; Apoplexy; Brain

Keywords

Mechanical thrombectomy; Endovascular thrombectomy

Outcome Measures

Primary Outcomes (1)

• Clinical outcome-modified Rankin Scale at 90 days

  The primary endpoint of the trial is the modified Rankin Scale (mRS) outcome at 90 days post-stroke. The primary effectiveness endpoint analysis is a chi-square test of the difference in linear trends in ordinal mRS outcomes at 90 days post-procedure between treatment groups ("mRS shift analysis").

  90 days

Secondary Outcomes (19)

• Independence - modified Rankin Scale≤2 at 90 days

  90 days

• Moderate Outcome - modified Rankin Scale≤3 at 90 days

  90 days

• Infarct volume 24 hours post procedure

  18-36 hours

• Infarct growth

  18-36 hours

• Functional neurological outcome at 12 months - modified Rankin Scale

  12 month

Study Arms (2)

Thrombectomy

ACTIVE COMPARATOR

Endovascular thrombectomy and best medical care

Device: Thrombectomy

Best medical care

OTHER

Best medical treatment

Other: Best medical care

Interventions

Thrombectomy DEVICE

Mechanical thrombectomy with state of the art thrombectomy devices (i.e. stent-retrievers, aspiration catheters). Devices will be used per instructions for use (IFU).

Also known as: Mechanical thrombectomy

Thrombectomy

Best medical care OTHER

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.

Also known as: Control group

Best medical care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Randomization within 11 hours after stroke onset (if known) or last seen well.
• 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
• 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

You may not qualify if:

• Patient is an active participant in another drug or device treatment trial for any disease state or patient is expected to start participation in another drug or device treatment trial while enrolled in this protocol, unless approved by Sponsor.
• 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

Sponsors & Collaborators

• University Hospital Heidelberg: lead
• Karolinska University Hospital: collaborator
• Eppdata GmbH Hamburg, Germany: collaborator
• Aarhus University Hospital: collaborator
• Medical University Innsbruck: collaborator
• Groupe Hospitalier Pitie-Salpetriere: collaborator
• Oslo University Hospital: collaborator
• University Hospital, Martin: collaborator
• Charles University, Czech Republic: collaborator
• Hospices Civils de Lyon: collaborator
• CHU de Reims: collaborator
• Epidemiological and Clinical Research Information Network: collaborator
• STROKE ALLIANCE FOR EUROPE: collaborator
• International Consortium for Health Outcome Measurement, Inc.: collaborator
• Europan Society for Minimally Invasive Neurological Therapy: collaborator
• Universitätsklinikum Hamburg-Eppendorf: collaborator

Study Sites (42)

Division of Neuroradiology, Vascular and Interventional Radiology, Department of Radiology, Medical University Graz

Graz, 8036, Austria

Location

Medical University Innsbruck

Innsbruck, 6020, Austria

Location

Neuroradiology, Keppler University Hospital Linz

Linz, 4020, Austria

Location

Department of Neurology, Reseach Institute of Neurointervention, Christian Doppler Clinic, Paracelsus Medical University Salzburg

Salzburg, 5020, Austria

Location

University of Calgary

Calgary, Alberta, T2N 1N4, Canada

Location

St. Anne's University Hospital Brno

Brno, 65691, Czechia

Location

Faculty Hospital Hradec Kralove

Hradec Králové, 50005, Czechia

Location

Comprehensive stroke center,University Hospital Ostrava

Ostrava, 70852, Czechia

Location

Homolka Hospital Prague

Prague, 150 30, Czechia

Location

Dept. of Radiology, Masaryk hospital

Ústí nad Labem, 40003, Czechia

Location

Aalborg University Hospital

Aalborg, 9000, Denmark

Location

Aarhus University Hospital

Aarhus, 8000, Denmark

Location

University Hospital Rigshospitalet

Copenhagen, 2100, Denmark

Location

CHU Gabriel Montpied, Clermont-Ferrand

Clermont-Ferrand, 63000, France

Location

Hôpiteaux Universitaires Paris-Sud, Hôpital Bicêtre

Le Kremlin-Bicêtre, 94270, France

Location

Hôpital Pitié-Salpêtrière

Paris, 75013, France

Location

Université Reims Champagne Ardenne/ Department of Neuroradiology, Hôpital Maison Blanche

Reims, 51100, France

Location

CHU de Rennes/Centre Urgences-Réanimations

Rennes, 35033, France

Location

CHRU Hôpiteaux de Tours / Hôpital Bretonneau

Tours, 37044, France

Location

Universitätsinstitut für Diagnostische Radiologie, Neuroradiologie und Nuklearmedizin Johannes Wesling Klinikum Minden

Minden, North Rhine-Westphalia, 32429, Germany

Location

Otto-von-Guericke-University Magdeburg

Magdeburg, Saxony-Anhalt, 39120, Germany

Location

Universitätsklinikum KK Bochum-Langendreer Institut für Diagnostische und Interventionelle Radiologie, Neuroradiologie und Nuklearmedizin

Bochum, 44892, Germany

Location

Universitätsklinikum Bonn

Bonn, 53127, Germany

Location

Gesundheit Nord gGmbH Klinikverbund Bremen

Bremen, 28211, Germany

Location

Klinik für Radiologie und Neuroradiologie am Klinikum Mitte

Dortmund, 44137, Germany

Location

Universitätsklinikum Carl Gustav Carus Dresden

Dresden, 01307, Germany

Location

Alfried Krupp Krankenhaus Rüttenscheid

Essen, 45131, Germany

Location

Diakonissenkrankenhaus Flensburg

Flensburg, 24939, Germany

Location

Universitätsklinikum Hamburg-Eppendorf

Hamburg, 20251, Germany

Location

Neuroradiologie Universitätsklinikum Heidelberg

Heidelberg, 69120, Germany

Location

Universitätsklinikum Leipzig AöR

Leipzig, 04103, Germany

Location

UKSH Universitätsklinikum Schleswig-Holstein Campus Lübeck

Lübeck, 23538, Germany

Location

Klinikum der Universität München

München, 81377, Germany

Location

Technische Universität München / Klinikum rechts der Isar

München, 81675, Germany

Location

Universitätsklinikum Würzburg

Würzburg, 97080, Germany

Location

Haukeland University Hospital

Bergen, 5021, Norway

Location

Oslo University Hospital

Oslo, NO-0407, Norway

Location

The Arctic University of Norway

Tromsø, 9038, Norway

Location

Comenius University's Jessenius Faculty of Medicine and University Hospital

Martin, 03659, Slovakia

Location

Faculty Hospital Trnava

Trnava, 91775, Slovakia

Location

La Paz University Hospital

Madrid, 28046, Spain

Location

University Hospital Basel

Basel, CH-4031, Switzerland

Location

Related Publications (7)

• 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.

  PMID: 30156479 BACKGROUND

• 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.

  PMID: 37837989 RESULT

• 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.

  PMID: 33502563 RESULT

• Broocks G, Bendszus M, Simonsen CZ, Thomalla G, Gizewski ER, Aamodt AH, Krajina A, Pierot L, Zelenak K, Fuentes B, Hill MD, Kemmling A, Gellissen S, Fiehler J, Meyer L, Kniep H; TENSION investigators; Tension Investigators. Net Water Uptake at CT Predicts the Treatment Effect of Thrombectomy for Low ASPECTS Stroke. Radiology. 2025 Nov;317(2):e250708. doi: 10.1148/radiol.250708.

  PMID: 41186468 DERIVED

• 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.

  PMID: 39998372 DERIVED

• 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.

  PMID: 39074480 DERIVED

• 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.

  PMID: 34125952 DERIVED

MeSH Terms

Conditions

Stroke

Interventions

Thrombectomy; Control Groups

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Götz Thomalla, MD

  Coordination and Project Management Tension, Neurology, UKE Hamburg, Germany

  STUDY CHAIR

• Martin Bendszus, MD

  Central Trial Management Tension, Neuroradiology, UHHeidelberg, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Central trial management, Coordinating investigator

Model Details: prospective, open label, blinded endpoint (PROBE), European, two-arm, randomized, controlled, post-market study

Study Record Dates

• First Submitted: March 16, 2017
• First Posted: March 29, 2017
• Study Start: June 20, 2018
• Primary Completion: May 31, 2023
• Study Completion: November 15, 2023
• Last Updated: December 5, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR

Locations

SL (2); ES (1); CH (1); CZ (5); NO (3); DK (3); FR (6); AU (4); DE (16); CA (1)