Stroke, Acute Clinical Trial
— TensionOfficial title:
Efficacy and Safety of Thrombectomy in Stroke With Extended Lesion and Extended Time Window: a Randomized, Controlled Trial
Verified date | November 2023 |
Source | University Hospital Heidelberg |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 253 |
Est. completion date | November 15, 2023 |
Est. primary completion date | May 31, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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. - 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 |
Country | Name | City | State |
---|---|---|---|
Austria | 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 | |
Canada | University of Calgary | Calgary | Alberta |
Czechia | St. Anne's University Hospital Brno | Brno | |
Czechia | Faculty Hospital Hradec Kralove | Hradec Kralove, | |
Czechia | Comprehensive stroke center,University Hospital Ostrava | Ostrava | |
Czechia | Homolka Hospital Prague | Prague | |
Czechia | Dept. of Radiology, Masaryk hospital | Usti nad Labem | |
Denmark | Aalborg University Hospital | Aalborg | |
Denmark | Aarhus University Hospital | Aarhus | |
Denmark | University Hospital Rigshospitalet | Copenhagen | |
France | 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 | |
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 | Otto-von-Guericke-University Magdeburg | Magdeburg | Sachsen-Anhalt |
Germany | Universitätsinstitut für Diagnostische Radiologie, Neuroradiologie und Nuklearmedizin Johannes Wesling Klinikum Minden | Minden | Nordrhein-Westfalen |
Germany | Klinikum der Universität München | München | |
Germany | Technische Universität München / Klinikum rechts der Isar | München | |
Germany | Universitätsklinikum Würzburg | Würzburg | |
Norway | Haukeland University Hospital | Bergen | |
Norway | Oslo University Hospital | Oslo | |
Norway | The Arctic University of Norway | Tromsø | |
Slovakia | Comenius University's Jessenius Faculty of Medicine and University Hospital | Martin | |
Slovakia | Faculty Hospital Trnava | Trnava | |
Spain | La Paz University Hospital | Madrid | |
Switzerland | University Hospital Basel | Basel |
Lead Sponsor | Collaborator |
---|---|
University Hospital Heidelberg | Aarhus University Hospital, Charles University, Czech Republic, CHU de Reims, Epidemiological and Clinical Research Information Network, Eppdata GmbH Hamburg, Germany, Europan Society for Minimally Invasive Neurological Therapy, Groupe Hospitalier Pitie-Salpetriere, Hospices Civils de Lyon, International Consortium for Health Outcome Measurement, Inc., Karolinska University Hospital, Medical University Innsbruck, Oslo University Hospital, STROKE ALLIANCE FOR EUROPE, Universitätsklinikum Hamburg-Eppendorf, University Hospital, Martin |
Austria, Canada, Czechia, Denmark, France, Germany, Norway, Slovakia, Spain, Switzerland,
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. — View Citation
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 — View Citation
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 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Independence - modified Rankin Scale=2 at 90 days | Independent neurological outcomes with 90-day mRS=2 | 90 days | |
Secondary | Moderate Outcome - modified Rankin Scale=3 at 90 days | Moderate neurological outcome with 90-day mRS=3 | 90 days | |
Secondary | Infarct volume 24 hours post procedure | Infarct volume at 24 hours on post-procedure imaging | 18-36 hours | |
Secondary | Infarct growth | Difference of infarct volume from infarct volume as predicted by pre-treatment imaging | 18-36 hours | |
Secondary | 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) | 12 month | |
Secondary | 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. | 90 days | |
Secondary | 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). | 90 days | |
Secondary | 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) | 90 days | |
Secondary | Parenchymal hemorrhage type 2 | blood clots in >30% of the infarcted area with a substantial space-occupying effect. | 90 days | |
Secondary | modified Rankin Scale between 4-6 | Death or dependency | 12 month | |
Secondary | 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 |
7 days | |
Secondary | 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). | 12 month | |
Secondary | Space-occupying infarction | Malignant brain edema after treatment | 18-36 hours | |
Secondary | New ischemic stroke | New AIS after treatment | 12 month | |
Secondary | 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 |
18-36 hours | |
Secondary | 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 | 12 month | |
Secondary | 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. | 12 month | |
Secondary | 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). | 12 month | |
Secondary | 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) | 12 month |
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