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NCT05029414

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

Sponsor: University Hospital, Basel, Switzerland

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

543

Start Date

2021-12-09

Completion Date

2025-06-01

Last Updated

2024-12-24

Healthy Volunteers

Conditions

Acute Ischemic Stroke

Interventions

PROCEDURE

Endovascular Therapy

Endovascular treatment of stroke is the non-surgical treatment for the sudden loss of brain function due to blood clots. The blood clot is removed from the blood via devices (i.e. stent-retriever, aspiration catheters and balloon guide) to achieve revascularization.

Inclusion Criteria: * Acute ischemic stroke * Treatment (arterial puncture) can be initiated 2.1. Within 6 hours of last seen well (LSW) OR 2.2. Within 6 to 24 hours of LSW AND * CT Criteria: Evidence of a hypoperfusion-hypodensity mismatch (Absence of hypodensity on the noncontrast CT within ≥ 90% of the area of the hypoperfused lesion on perfusion CT) * MRI Criteria: Evidence of a diffusion-hyperintensity mismatch (Absence of hyperintensity on fluid-attenuated inversion recovery (FLAIR) imaging within ≥ 90% of the area of the diffusion weighted imaging(DWI) lesion) * Isolated medium vessel occlusion (i.e. an occlusion of the co-/non-dominant M2, the M3/M4 segment of theMCA, the A1/A2/A3 segment of the ACA or the P1/P2/P3 segment of the PCA) confirmed by CT or MRIAngiography * National Institute of Health Stroke Scale (NIHSS) Score of ≥ 4 points or symptoms deemed clearly disabling by treating physician (i.e. aphasia, hemianopia, etc.) * Informed Consent as documented by signature or fulfilling the criteria for emergency consent/ deferral consent * Agreement of treating physician to perform endovascular procedure Exclusion Criteria: * Acute intracranial haemorrhage * Patient bedridden or presenting from a nursing home * In-Hospital Stroke * Known (serious) sensitivity to radiographic contrast agents, nickel, titanium metals or their alloys * Foreseeable difficulties in follow-up due to geographic reasons (e.g. patients living abroad) * Pregnancy or lactating women. A negative pregnancy test before randomisation is required for all women with child-bearing potential. * Known history of arterial tortuosity, pre-existing stent, other arterial disease and/or known disease at the arterial access site that would prevent the device from reaching the target vessel and/or preclude safe recovery after EVT * Severe comorbidities, which will likely prevent improvement or follow-up * Radiological confirmed evidence of mass effect or intracranial tumour (except small meningioma) * Radiological confirmed evidence of cerebral vasculitis * Evidence of vessel recanalization prior to randomisation * Participation in another interventional trial

Locations (56)

AZ Sint-Jan Brugge

Bruges, Belgium

Hôpital Civil Marie Curie Charleroi

Charleroi, Belgium

UZ Universiteit Gent

Ghent, Belgium

AZ Groeninge

Kortrijk, Belgium

Universitair Ziekenhuis Leuven

Leuven, Belgium

Clinique CHC MontLégia

Liège, Belgium

Helsinki University Hospital

Helsinki, Finland

Turku University Hospital

Turku, Finland

Uniklinik RHTW Aachen

Aachen, Germany

Charité-Universitätsmedizin Berlin

Berlin, Germany

Klinikum Bremen-Mitte

Bremen, Germany

Uniklinikum Dresden

Dresden, Germany

Helios Klinikum Erfurt

Erfurt, Germany

University Hospital Frankfurt

Frankfurt, Germany

University Medical Center Göttingen

Göttingen, Germany

Asklepios Klinik Altona, Hamburg

Hamburg, Germany

University Hospital Hamburg Eppendorf

Hamburg, Germany

University Medical Center Mannheim

Mannheim, Germany

Universitätsklinikum der Technischen Universität München

München, Germany

University Hospital Münster

Münster, Germany

Klinikum Nürnberg

Nuremberg, Germany

Klinikum VEST GmbH

Recklinghausen, Germany

Klinikum der Landeshauptstadt Stuttgart gKAöR

Stuttgart, Germany

Hadassah-Hebrew University Medical Center

Jerusalem, Israel

Maggiore Hospital

Bologna, Italy

Careggi University Hospital,

Florence, Italy

Antonio Cardarelli Hospital

Naples, Italy

San Giovanni Bosco Hospital

Torino, Italy

Amsterdam University Medical Center

Amsterdam, Netherlands

Rijnstate Hospital Arnhem

Arnhem, Netherlands

University Medical Center Groningen

Groningen, Netherlands

Leiden University Medical Center

Leiden, Netherlands

Maastricht University Medical Center

Maastricht, Netherlands

Radboud University Medical Center Nijmegen

Nijmegen, Netherlands

Erasmus MC University Medical Center Rotterdam

Rotterdam, Netherlands

Haaglanden Medical Center

The Hague, Netherlands

Lisbon Central University Hospital

Lisbon, Portugal

Hospital Clinico Barcelona

Barcelona, Spain

Hospital Vall d'Hebron

Barcelona, Spain

University Hospital Germans Trias i Pujol

Barcelona, Spain

University Hospital Doctor Josep Trueta, Girona

Girona, Spain

University Hospital Clínico San Carlos, Madrid

Madrid, Spain

University Hospital Virgen de la Arrixaca, Murcia

Murcia, Spain

Hospital Clinico Universitario de Valladolid

Valladolid, Spain

Skane University Hospital

Lund, Sweden

Kantonsspital Aarau, Department of Interventional and Diagnostical Neuroradiology

Aarau, Switzerland

Department of Interventional and Diagnostical Neuroradiology, Clinic of Radiology and Nuclear Medicine, University Hospital Basel

Basel, Switzerland

Department of Neurology, University Hospital Basel

Basel, Switzerland

Inselspital Bern, University Clinic for Neuroradiology

Bern, Switzerland

Geneva University Hospitals, Interventional Neuroradiology Unit

Geneva, Switzerland

Centre hospitalier universitaire vaudois, CHUV

Lausanne, Switzerland

Kantonsspital Luzern

Lucerne, Switzerland

Neurocentro (EOC) della Svizzera Italiana Stroke Center, Servizio di Neurologia, Ospedale Civico

Lugano, Switzerland

Kantonsspital St Gallen

Sankt Gallen, Switzerland

University Hospital Zurich, Departement of Neuroradiology

Zurich, Switzerland

Barts NHS Health Trust

London, United Kingdom

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (56)