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Studies

Interventional Recruiting

NCT05029414 on ClinicalTrials.gov

EnDovascular Therapy Plus Best Medical Treatment (BMT) Versus BMT Alone for MedIum VeSsel Occlusion sTroke

Official title: EnDovascular Therapy Plus Best Medical Treatment (BMT) Versus BMT Alone for MedIum VeSsel Occlusion sTroke - a prAgmatic, International, Multicentre, Randomized triaL (DISTAL)

  • Sponsor: University Hospital of Basel
  • Collaborators: Swiss National Fund for Scientific Research, Stryker Neurovascular, Penumbra Inc., Medtronic, Phenox GmbH, Rapid Medical, Gottfried und Julia Bangerter-Rhyner-Stiftung
  • Enrollment: 526 (Estimated)
  • Study start: 2021-12-09 (Actual)
  • Primary completion: 2024-12-01 (Estimated)
  • Study completion: 2024-12-01 (Estimated)
  • Allocation: Randomized
  • InterventionModel: Parallel
  • InterventionModelDescription: Pragmatic, parallel group, randomized, open label, superiority trial with blinded endpoint assessment
  • Masking: Single (Outcomes Assessor)
  • PrimaryPurpose: Treatment

Brief Summary

Acute ischemic stroke (AIS) is one of the main causes of disability and loss of quality adjusted life years. This study is to analyze whether endovascular therapy (EVT) in addition to best medical treatment (BMT) reduces the degree of disability and dependency in daily activities after a Medium Vessel Occlusion (MeVO) stroke compared to BMT alone.

Conditions

  • Acute Ischemic Stroke

Intervention / Treatment

  • Procedure: Endovascular Therapy

Primary Outcome Measures

  • Degree of dependency and disability in everyday life (measured with the mRS) (at 90 days (± 14 days) after randomisation)
    The primary outcome is the degree of dependency and disability in everyday life (measured with the mRS) at 90 days. The mRS is the standard tool to assess neurological outcome in trials with acute severe brain disease. The scale runs from 0-6, running from perfect health without symptoms (= 0) to death (= 6).

Countries

Belgium, Finland, Germany, Spain, Switzerland, United Kingdom

Locations and Investigators

  • Universitair Ziekenhuis Brussel, Brussel, Belgium (Recruiting)
    • Petra Dierickx
    • Frans Van den Bergh, Dr (Principal Investigator)
  • Hôpital Civil Marie Curie Charleroi, Charleroi, Belgium (Recruiting)
    • Anne Dusart, Dr
    • Flavio Bellante, Dr (Principal Investigator)
  • UZ Universiteit Gent, Gent, Belgium (Recruiting)
    • Lynn Huyck
    • Luc Defreyne, Prof (Principal Investigator)
  • AZ Groeninge, Groeninge, Belgium (Recruiting)
    • Anne-Sophie Desloovere
    • Olivier Francois, Dr (Principal Investigator)
  • Universitair Ziekenhuis Leuven, Leuven, Belgium (Recruiting)
    • Annemie Devroye
    • Robin Lemmens, Prof Dr (Principal Investigator)
  • Clinique CHC MontLégia, Liege, Belgium (Recruiting)
    • Karima Bouaassam
    • Philippe Desfontaines (Principal Investigator)
  • Helsinki University Hospital, Helsinki, Finland (Recruiting)
    • Daniel Strbian, Prof
    • Daniel Strbian, Prof (Principal Investigator)
  • Uniklinik RHTW Aachen, Aachen, Germany (Not yet recruiting)
    • Andrea Stockero
    • Martin Wiesmann, Prof Dr (Principal Investigator)
  • Charité-Universitätsmedizin Berlin, Berlin, Germany (Recruiting)
  • Universitätsklinikum Knappschaftskrankenhaus Bochum, Bochum, Germany (Recruiting)
    • Sebastian Fischer
    • Sebastian Fischer (Principal Investigator)
  • Uniklinikum Dresden, Dresden, Germany (Recruiting)
    • Kathrin Haase
    • Daniel Kaiser, Dr (Principal Investigator)
    • Volker Pütz, Dr (Principal Investigator)
  • University Hospital Hamburg Eppendorf, Hamburg, Germany (Recruiting)
    • Götz Thomalla, Prof. Dr.
    • Götz Thomalla, Prof Dr (Principal Investigator)
    • Jens Fiehler, Prof Dr (Principal Investigator)
  • LMU Klinikum München, München, Germany (Recruiting)
    • Konstantinos Dimitriadis, Dr
    • Martin Dichgans, Prof Dr (Principal Investigator)
  • Universitätsklinikum der Technischen Universität München, München, Germany (Recruiting)
    • Sandra Baudrexl
    • Jan Kirschke, Prof Dr (Principal Investigator)
  • Klinikum Nürnberg, Nürnberg, Germany (Recruiting)
    • Sabine Kohler
    • Markus Holtmannspötter, Dr (Principal Investigator)
    • Jan Liman, Prof Dr (Principal Investigator)
  • Klinikum VEST GmbH, Recklinghausen, Germany (Recruiting)
    • R Hilker-Roggendorf, Prof
    • R Hilker-Roggendorf, Prof (Principal Investigator)
  • Klinikum der Landeshauptstadt Stuttgart gKAöR, Stuttgart, Germany (Recruiting)
    • Victoria Hellstern, Dr
    • Victoria Hellstern, Dr (Principal Investigator)
  • Hospital Clinico Barcelona, Barcelona, Spain (Recruiting)
    • Martha Vargas
    • Sergio Amaro (Principal Investigator)
  • Hospital Vall d'Hebron, Barcelona, Spain (Recruiting)
    • Marc J Ribo, PhD
    • Marc J Ribo, PhD (Principal Investigator)
  • University Hospital Germans Trias i Pujol, Barcelona, Spain (Recruiting)
    • Martí Boix
    • Carlos Castaño Duque, PD Dr (Principal Investigator)
  • Hospital Clinico Universitario de Valladolid, Valladolid, Spain (Recruiting)
  • Kantonsspital Aarau, Department of Interventional and Diagnostical Neuroradiology, Aarau, Switzerland (Recruiting)
    • Philipp Gruber, PD Dr.
    • Philipp Gruber, PD Dr. (Principal Investigator)
  • Department of Interventional and Diagnostical Neuroradiology, Clinic of Radiology and Nuclear Medicine, University Hospital Basel, Basel, Switzerland (Recruiting)
    • Marios-Nikos Psychogios, Prof. Dr.
    • Alex Brehm, Dr.
    • Marios-Nikos Psychogios, Prof. Dr. (Principal Investigator)
  • Department of Neurology, University Hospital Basel, Basel, Switzerland (Recruiting)
    • Urs Fischer, Prof. Dr.
    • Urs Fischer, Prof. Dr. (Principal Investigator)
  • Inselspital Bern, University Clinic for Neuroradiology, Bern, Switzerland (Recruiting)
    • Jan Gralla, Prof. Dr.
    • Jan Gralla, Prof. Dr. (Principal Investigator)
  • Geneva University Hospitals, Interventional Neuroradiology Unit, Genf, Switzerland (Recruiting)
    • Paolo Machi, Prof. Dr.
    • Paolo Machi, Prof. Dr. (Principal Investigator)
  • Centre hospitalier universitaire vaudois, CHUV, Lausanne, Switzerland (Recruiting)
    • Patrik Michel, Prof. Dr.
    • Patrik Michel, Prof. Dr. (Principal Investigator)
    • Steven Hajdu, Dr. (Principal Investigator)
  • Neurocentro (EOC) della Svizzera Italiana Stroke Center, Servizio di Neurologia, Ospedale Civico, Lugano, Switzerland (Recruiting)
    • Carlo Cereda, PD Dr.
    • Carlo Cereda, PD Dr. (Principal Investigator)
    • Allesandro Cianfoni, Prof Dr. (Principal Investigator)
  • Kantonsspital Luzern, Luzern, Switzerland (Recruiting)
    • Alexander von Hessling, Dr. med
    • Alexander von Hessling, Dr med (Principal Investigator)
    • Manuel Bolognese, Dr med (Principal Investigator)
  • Kantonsspital St Gallen, Saint Gallen, Switzerland (Recruiting)
    • Georg Kagi, PD Dr
    • Georg Kagi, PD Dr (Principal Investigator)
    • Claudia Hager, Dr (Principal Investigator)
  • University Hospital Zurich, Departement of Neuroradiology, Zürich, Switzerland (Recruiting)
    • Zsolt Kulcsar, PD Dr.
    • Zsolt Kulcsar, PD Dr. (Principal Investigator)
  • Barts NHS Health Trust, London, United Kingdom (Not yet recruiting)
    • Paul Bhogal, Dr med
    • Paul Bhogal, Dr med (Principal Investigator)
  • University Hospitals of North Midlands NHS Trust, Stoke-on-Trent, United Kingdom (Not yet recruiting)
    • Sanjeev Nayak, Dr. med.
    • Sanjeev Nayak, Dr. med. (Principal Investigator)

Study Officials