Stroke, AcuteTensionNCT03094715
Efficacy and Safety of Thrombectomy in Stroke With Extended Lesion and Extended Time Window
A study testing Thrombectomy and Best medical care in people with Stroke, Acute and Cerebral Stroke, run by University Hospital Heidelberg at 42 sites in 10 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Acute, Cerebral Stroke, Cerebrovascular Stroke
- What is being tested?
- Thrombectomy and Best medical care
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 253 participants
- Where
- 42 sitesin 10 countries
- Study dates
- 20 Jun 2018to 15 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- 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.
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- Prior to new focal neurological deficit, mRS score was ≤2.
- Imaging Inclusion Criteria
- 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
- Clinical exclusion criteria
- 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
- Imaging exclusion criteria
- 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
Who cannot join
None listed.
Trial locations and contacts
42 sites in 10 countries.
42 sites in 10 countries
Germany16 sites
Universitätsklinikum KK Bochum-Langendreer Institut für Diagnostische und Interventionelle Radiologie, Neuroradiologie und Nuklearmedizin
Bochum, 44892
Universitätsklinikum Bonn
Bonn, 53127
Gesundheit Nord gGmbH Klinikverbund Bremen
Bremen, 28211
Klinik für Radiologie und Neuroradiologie am Klinikum Mitte
Dortmund, 44137
Universitätsklinikum Carl Gustav Carus Dresden
Dresden, 01307
Alfried Krupp Krankenhaus Rüttenscheid
Essen, 45131
Diakonissenkrankenhaus Flensburg
Flensburg, 24939
Universitätsklinikum Hamburg-Eppendorf
Hamburg, 20251
Neuroradiologie Universitätsklinikum Heidelberg
Heidelberg, 69120
Universitätsklinikum Leipzig AöR
Leipzig, 04103
UKSH Universitätsklinikum Schleswig-Holstein Campus Lübeck
Lübeck, 23538
Otto-von-Guericke-University Magdeburg
Magdeburg, Saxony-Anhalt, 39120
Universitätsinstitut für Diagnostische Radiologie, Neuroradiologie und Nuklearmedizin Johannes Wesling Klinikum Minden
Minden, North Rhine-Westphalia, 32429
Klinikum der Universität München
München, 81377
Technische Universität München / Klinikum rechts der Isar
München, 81675
Universitätsklinikum Würzburg
Würzburg, 97080
France6 sites
CHU Gabriel Montpied, Clermont-Ferrand
Clermont-Ferrand, 63000
Hôpiteaux Universitaires Paris-Sud, Hôpital Bicêtre
Le Kremlin-Bicêtre, 94270
Hôpital Pitié-Salpêtrière
Paris, 75013
Université Reims Champagne Ardenne/ Department of Neuroradiology, Hôpital Maison Blanche
Reims, 51100
CHU de Rennes/Centre Urgences-Réanimations
Rennes, 35033
CHRU Hôpiteaux de Tours / Hôpital Bretonneau
Tours, 37044
Czechia5 sites
St. Anne's University Hospital Brno
Brno, 65691
Faculty Hospital Hradec Kralove
Hradec Králové, 50005
Comprehensive stroke center,University Hospital Ostrava
Ostrava, 70852
Homolka Hospital Prague
Prague, 150 30
Dept. of Radiology, Masaryk hospital
Ústí nad Labem, 40003
Austria4 sites
Division of Neuroradiology, Vascular and Interventional Radiology, Department of Radiology, Medical University Graz
Graz, 8036
Medical University Innsbruck
Innsbruck, 6020
Neuroradiology, Keppler University Hospital Linz
Linz, 4020
Department of Neurology, Reseach Institute of Neurointervention, Christian Doppler Clinic, Paracelsus Medical University Salzburg
Salzburg, 5020
Denmark3 sites
Aalborg University Hospital
Aalborg, 9000
Aarhus University Hospital
Aarhus, 8000
University Hospital Rigshospitalet
Copenhagen, 2100
Norway3 sites
Haukeland University Hospital
Bergen, 5021
Oslo University Hospital
Oslo, NO-0407
The Arctic University of Norway
Tromsø, 9038
Slovakia2 sites
Comenius University's Jessenius Faculty of Medicine and University Hospital
Martin, 03659
Faculty Hospital Trnava
Trnava, 91775
About this study
Official title: Efficacy and Safety of Thrombectomy in Stroke With Extended Lesion and Extended Time Window: a Randomized, Controlled Trial
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.
Read the detailed description
This study 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 (AIS) in patients with extended stroke lesions defined by an ASPECT score of 3-5 and in an extended time window (up to 12 hours, or unknown time of symptom onset). This is an adaptive design study, with prospectively stated interim analyses with specified stopping rules allowing for the possibility early termination based on either a determination of study success or futility.
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.
- Being tested
- Thrombectomy, Best medical care
- Keywords
- Mechanical thrombectomy, Endovascular thrombectomy
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThrombectomyDevice
Also called Mechanical 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 careOther
Also called Control group
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.
| Study group | Role | What they receive |
|---|---|---|
| Thrombectomy | Active comparator | Endovascular thrombectomy and best medical care Receives: Device: Thrombectomy |
| Best medical care | Other | Best medical treatment Receives: Other: Best medical care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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").
Measured: 90 days
Secondary outcomes (19)
Independence - modified Rankin Scale≤2 at 90 days
Independent neurological outcomes with 90-day mRS≤2
Measured: 90 days
Moderate Outcome - modified Rankin Scale≤3 at 90 days
Moderate neurological outcome with 90-day mRS≤3
Measured: 90 days
Infarct volume 24 hours post procedure
Infarct volume at 24 hours on post-procedure imaging
Measured: 18-36 hours
Infarct growth
Difference of infarct volume from infarct volume as predicted by pre-treatment imaging
Measured: 18-36 hours
Functional neurological outcome at 12 months - modified Rankin Scale
Functional neurological outcome at 12 months (±14 days) after stroke (simplified modified Rankin Scale questionnaire, smRSq)
Measured: 12 month
Quality of life - PROMIS-10
Patient-Reported Outcomes Measurement Information System (PROMIS)-10 questionaire at 90 (±14) days. PROMIS Global-10 short form consists of 10 items that assess general domains of health and functioning including overall physical health, mental health, social health, pain, fatigue, and overall perceived quality of life.
Measured: 90 days
Quality of life - EQ-5D
Patient-reported functional health status and quality of life 90 (±14) days. EuroQol five-dimension scale. A standardised instrument created by the EuroQol Group as a measure of health outcome. EQ-5D is a descriptive system of health-related quality of life states consisting of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), each of which can take one of three responses reflecting severity (no problems/some or moderate problems/extreme problems).
Measured: 90 days
Post-stroke depression - Patient Health Questionnaire-4
Post-stroke depression 90 (±14) days after stroke based on the Patient Health Questionnaire-4 (PHQ-4), Patient Health Questionnaire-4, Psychological distress in PHQ-4 is being rated based on 4 questions as none (0-2") mild (3-5) moderate (6-8) severe (9-12)
Measured: 90 days
Parenchymal hemorrhage type 2
blood clots in >30% of the infarcted area with a substantial space-occupying effect.
Measured: 90 days
modified Rankin Scale between 4-6
Death or dependency
Measured: 12 month
Frequencies of Adverse Events (AE) in both treatment arms within the first 7 days
Serious AEs (SAEs), overall (all-cause mortality) and stroke-related death (i.e., related to intracranial bleeding, midline shift, brain herniation, progression of stroke symptoms, or systemic complications from stroke such as pneumonia).
- Space-occupying infarction (malignant brain edema)
- New ischemic stroke
Measured: 7 days
Serious AEs
Serious AEs (SAEs), overall (all-cause mortality) and stroke-related death (i.e., related to intracranial bleeding, midline shift, brain herniation, progression of stroke symptoms, or systemic complications from stroke such as pneumonia).
Measured: 12 month
Space-occupying infarction
Malignant brain edema after treatment
Measured: 18-36 hours
New ischemic stroke
New AIS after treatment
Measured: 12 month
Symptomatic intracranial hemorrhage (sICH) at 24 (18-36) hours (CT or MRI)
sICH as defined in Safe Implementation of Treatments in Stroke-Monitoring Study (SITS-MOST)
- parenchymal hemorrhage type 2 (PH-2)
- Frequencies of Adverse Events (AE) in both treatment arms within the first 7 days after treatment
- Serious AEs (SAEs), overall (all-cause mortality) and stroke-related death (i.e., related to intracranial bleeding, midline shift, brain herniation, progression of stroke symptoms, or systemic complications from stroke such as pneumonia).
- Space-occupying infarction (malignant brain edema)
- New ischemic stroke
Measured: 18-36 hours
Cost Utility Assessment
Assessment of costs from the time of randomization to the 12-months follow-up, including costs of hospitalization, institutionalized living, outpatient care, informal care provided by relatives and cost of lost productivity
Measured: 12 month
Quality of life - PROMIS-10
Patient-Reported Outcomes Measurement Information System (PROMIS)-10 questionaire at 12 month (±14 days). PROMIS Global-10 short form consists of 10 items that assess general domains of health and functioning including overall physical health, mental health, social health, pain, fatigue, and overall perceived quality of life.
Measured: 12 month
Quality of life - EQ-5D
Health related quality of life assessment at 12 months (±14 days). EuroQol five-dimension scale. A standardised instrument created by the EuroQol Group as a measure of health outcome. EQ-5D is a descriptive system of health-related quality of life states consisting of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), each of which can take one of three responses reflecting severity (no problems/some or moderate problems/extreme problems).
Measured: 12 month
Post-stroke depression - Patient Health Questionnaire-4
Health related quality of life assessment at 12 months (±14 days) to assess post stroke depression - Patient Health Questionnaire-4 (PHQ-4) Psychological distress in PHQ-4 is being rated based on 4 questions as none (0-2") mild (3-5) moderate (6-8) severe (9-12)
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2017
- Study start20 Jun 2018
- Primary completion31 May 2023
- Study completion15 Nov 2023
Why it stopped: Publication of results of competing trials SELECT2 \& Angel Aspect
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Stroke, AcuteStudies of the same condition, open and under way.
- More trials run by University Hospital HeidelbergThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- prospective, open label, blinded endpoint (PROBE), European, two-arm, randomized, controlled, post-market study
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 253 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Heidelberg
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska University Hospital, Eppdata GmbH Hamburg, Germany, Aarhus University Hospital, Medical University Innsbruck, Groupe Hospitalier Pitie-Salpetriere, Oslo University Hospital, University Hospital, Martin, Charles University, Czech Republic, Hospices Civils de Lyon, CHU de Reims, Epidemiological and Clinical Research Information Network, STROKE ALLIANCE FOR EUROPE, International Consortium for Health Outcome Measurement, Inc., Europan Society for Minimally Invasive Neurological Therapy, Universitätsklinikum Hamburg-Eppendorf
- Responsible party
- Principal investigator, Martin Bendszus, University Hospital Heidelberg
- Investigators
- Götz Thomalla, MD, Study chair, Coordination and Project Management Tension, Neurology, UKE Hamburg, GermanyMartin Bendszus, MD, Principal investigator, Central Trial Management Tension, Neuroradiology, UHHeidelberg, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03094715
- Sponsor's protocol ID
- TENSION
- Acronym
- Tension
- Status last verified
- Nov 2023
- First submitted
- 16 Mar 2017
- Last updated
- 5 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes
Publications
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.
PubMed 30156479Bendszus 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.
PubMed 37837989van 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.
PubMed 33502563Schlemm E, Jensen M, Schell 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, Denis A, Deutschmann H, Dorn F, Flottmann F, Gellissen S, Gerber JC, Goyal M, Haring J, Herweh C, Hopf-Jensen S, Hua VT, Kastrup A, Keil CF, Klepanec A, Kurca E, Meyer L, 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, Schonenberger S, Tennoe B, Ulfert C, Valis K, Vitkova E, Vollherbst DF, Wick W, Bendszus M, Cheng B, Thomalla G; TENSION Investigators *. Large Core Stroke Thrombectomy Is Safe and Effective Regardless of Prior Antithrombotic or Thrombolytic Treatment: A Secondary Analysis of the Randomized TENSION Trial. J Am Heart Assoc. 2026 Jun 16;15(12):e047192. doi: 10.1161/JAHA.125.047192. Epub 2026 Jun 9.
PubMed 42261979Broocks 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.
PubMed 41186468Winkelmeier 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.
PubMed 39998372Thomalla 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.
PubMed 39074480Roaldsen 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.
PubMed 34125952
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Thrombectomy in Stroke With Extended Lesion and Extended Time Window: a Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT03094715
- Acronym / sponsor ID
- Tension / TENSION
- Keywords
- Mechanical thrombectomy, Endovascular thrombectomy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Publication of results of competing trials SELECT2 \& Angel Aspect
- Enrolment
- 253 participants (actual)
- Lead sponsor
- University Hospital HeidelbergUniversity, hospital or other
- Collaborators
- Karolinska University Hospital, Eppdata GmbH Hamburg, Germany, Aarhus University Hospital, Medical University Innsbruck, Groupe Hospitalier Pitie-Salpetriere, Oslo University Hospital, University Hospital, Martin, Charles University, Czech Republic, Hospices Civils de Lyon, CHU de Reims, Epidemiological and Clinical Research Information Network, STROKE ALLIANCE FOR EUROPE, International Consortium for Health Outcome Measurement, Inc., Europan Society for Minimally Invasive Neurological Therapy, Universitätsklinikum Hamburg-Eppendorf
- Study start
- 20 Jun 2018 (actual)
- Primary completion
- 31 May 2023 (actual)
- Study completion
- 15 Nov 2023 (actual)
- First posted
- 29 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study 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 (AIS) in patients with extended stroke lesions defined by an ASPECT score of 3-5 and in an extended time window (up to 12 hours, or unknown time of symptom onset). This is an adaptive design study, with prospectively stated interim analyses with specified stopping rules allowing for the possibility early termination based on either a determination of study success or futility.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- prospective, open label, blinded endpoint (PROBE), European, two-arm, randomized, controlled, post-market study
| Arm | Type | Receives |
|---|---|---|
| Thrombectomy | Active comparator | Device: ThrombectomyEndovascular thrombectomy and best medical care |
| Best medical care | Other | Other: Best medical careBest medical treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ThrombectomyAlso: Mechanical thrombectomyMechanical thrombectomy with state of the art thrombectomy devices (i.e. stent-retrievers, aspiration catheters). Devices will be used per instructions for use (IFU). | Device | Thrombectomy |
| Best medical careAlso: Control groupBest 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 | Best medical care |
Primary outcome
Clinical outcome-modified Rankin Scale at 90 days
Time frame: 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").
19 secondary outcomes
Independence - modified Rankin Scale≤2 at 90 days
Time frame: 90 days
Moderate Outcome - modified Rankin Scale≤3 at 90 days
Time frame: 90 days
Infarct volume 24 hours post procedure
Time frame: 18-36 hours
Infarct growth
Time frame: 18-36 hours
Functional neurological outcome at 12 months - modified Rankin Scale
Time frame: 12 month
Quality of life - PROMIS-10
Time frame: 90 days
Quality of life - EQ-5D
Time frame: 90 days
Post-stroke depression - Patient Health Questionnaire-4
Time frame: 90 days
Parenchymal hemorrhage type 2
Time frame: 90 days
modified Rankin Scale between 4-6
Time frame: 12 month
Frequencies of Adverse Events (AE) in both treatment arms within the first 7 days
Time frame: 7 days
Serious AEs
Time frame: 12 month
Space-occupying infarction
Time frame: 18-36 hours
New ischemic stroke
Time frame: 12 month
Symptomatic intracranial hemorrhage (sICH) at 24 (18-36) hours (CT or MRI)
Time frame: 18-36 hours
Cost Utility Assessment
Time frame: 12 month
Quality of life - PROMIS-10
Time frame: 12 month
Quality of life - EQ-5D
Time frame: 12 month
Post-stroke depression - Patient Health Questionnaire-4
Time frame: 12 month
Results and safety
The study was stopped early (reason given: Publication of results of competing trials SELECT2 \& Angel Aspect). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2023.
- Background: PubMed 30156479Bendszus 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.
- Results publication: PubMed 37837989Bendszus 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.
- Results publication: PubMed 33502563van 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.
- Derived from this study: PubMed 42261979Schlemm E, Jensen M, Schell 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, Denis A, Deutschmann H, Dorn F, Flottmann F, Gellissen S, Gerber JC, Goyal M, Haring J, Herweh C, Hopf-Jensen S, Hua VT, Kastrup A, Keil CF, Klepanec A, Kurca E, Meyer L, 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, Schonenberger S, Tennoe B, Ulfert C, Valis K, Vitkova E, Vollherbst DF, Wick W, Bendszus M, Cheng B, Thomalla G; TENSION Investigators *. Large Core Stroke Thrombectomy Is Safe and Effective Regardless of Prior Antithrombotic or Thrombolytic Treatment: A Secondary Analysis of the Randomized TENSION Trial. J Am Heart Assoc. 2026 Jun 16;15(12):e047192. doi: 10.1161/JAHA.125.047192. Epub 2026 Jun 9.
- Derived from this study: PubMed 41186468Broocks 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.
- Derived from this study: PubMed 39998372Winkelmeier 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.
- Derived from this study: PubMed 39074480Thomalla 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.
- Derived from this study: PubMed 34125952Roaldsen 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Götz Thomalla, MD study chair
Coordination and Project Management Tension, Neurology, UKE Hamburg, Germany
Martin Bendszus, MD principal investigator
Central Trial Management Tension, Neuroradiology, UHHeidelberg, Germany
42 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thrombectomy and Best medical care in people with Stroke, Acute and Cerebral Stroke, run by University Hospital Heidelberg at 42 sites in 10 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 22 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 42 sites in Germany, France, Czechia, Austria, Denmark and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Publication of results of competing trials SELECT2 \& Angel Aspect). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical outcome-modified Rankin Scale at 90 days (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03094715, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2023.