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

Last updated: December 19, 2024
Sponsor: University Hospital, Basel, Switzerland
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Cardiac Ischemia

Stroke

Blood Clots

Treatment

Endovascular Therapy

Clinical Study ID

NCT05029414
2021-01692; qu20Psychogios2
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 ofhypodensity on the noncontrast CT within ≥ 90% of the area of the hypoperfusedlesion on perfusion CT)

  • MRI Criteria: Evidence of a diffusion-hyperintensity mismatch (Absence ofhyperintensity 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, theM3/M4 segment of theMCA, the A1/A2/A3 segment of the ACA or the P1/P2/P3 segment ofthe PCA) confirmed by CT or MRIAngiography

  • National Institute of Health Stroke Scale (NIHSS) Score of ≥ 4 points or symptomsdeemed clearly disabling by treating physician (i.e. aphasia, hemianopia, etc.)

  • Informed Consent as documented by signature or fulfilling the criteria for emergencyconsent/ deferral consent

  • Agreement of treating physician to perform endovascular procedure

Exclusion

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 metalsor their alloys

  • Foreseeable difficulties in follow-up due to geographic reasons (e.g. patientsliving abroad)

  • Pregnancy or lactating women. A negative pregnancy test before randomisation isrequired for all women with child-bearing potential.

  • Known history of arterial tortuosity, pre-existing stent, other arterial diseaseand/or known disease at the arterial access site that would prevent the device fromreaching 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 smallmeningioma)

  • Radiological confirmed evidence of cerebral vasculitis

  • Evidence of vessel recanalization prior to randomisation

  • Participation in another interventional trial

Study Design

Total Participants: 543
Treatment Group(s): 1
Primary Treatment: Endovascular Therapy
Phase:
Study Start date:
December 09, 2021
Estimated Completion Date:
June 01, 2025

Study Description

Acute ischemic stroke (AIS) is one of the main causes of death and disability and thereby the third leading cause of loss of quality adjusted life years. For patients with an AIS due to an occlusion of the large vessels of the anterior circulation, endovascular therapy (EVT) has become a treatment standard. 20-40% of all AIS patients have occlusions of smaller vessels and present with a more distal isolated Medium Vessel Occlusion (MeVO). The primary objective of this randomized trial is to determine whether patients experiencing an AIS due to an isolated medium vessel occlusion have superior functional outcome (measured with the Modified Rankin Scale "mRS" at 90 days) when treated with EVT plus best medical treatment (BMT) compared to patients treated with BMT alone. In this trial, all commercially available, CE-certified revascularisation devices (i.e. stent-retriever, aspiration catheters and balloon guide catheters) can be used for EVT. All established techniques for the endovascular treatment of AIS patients are permitted and all decisions regarding treatment technique and choice of devices and/or medications are made solely by the treating physician.

Connect with a study center

  • AZ Sint-Jan Brugge

    Brugge,
    Belgium

    Site Not Available

  • Universitair Ziekenhuis Brussel

    Brussel,
    Belgium

    Site Not Available

  • Hôpital Civil Marie Curie Charleroi

    Charleroi,
    Belgium

    Site Not Available

  • UZ Universiteit Gent

    Gent,
    Belgium

    Site Not Available

  • AZ Groeninge

    Groeninge,
    Belgium

    Site Not Available

  • AZ Groeninge

    Kortrijk,
    Belgium

    Site Not Available

  • Universitair Ziekenhuis Leuven

    Leuven,
    Belgium

    Site Not Available

  • Clinique CHC MontLégia

    Liege,
    Belgium

    Site Not Available

  • Helsinki University Hospital

    Helsinki,
    Finland

    Site Not Available

  • Turku University Hospital

    Turku,
    Finland

    Site Not Available

  • Uniklinik RHTW Aachen

    Aachen,
    Germany

    Site Not Available

  • Charité-Universitätsmedizin Berlin

    Berlin,
    Germany

    Site Not Available

  • Universitätsklinikum Knappschaftskrankenhaus Bochum

    Bochum,
    Germany

    Site Not Available

  • Klinikum Bremen-Mitte

    Bremen,
    Germany

    Site Not Available

  • Uniklinikum Dresden

    Dresden,
    Germany

    Site Not Available

  • Helios Klinikum Erfurt

    Erfurt,
    Germany

    Site Not Available

  • University Hospital Frankfurt

    Frankfurt,
    Germany

    Site Not Available

  • University Medical Center Göttingen

    Göttingen,
    Germany

    Site Not Available

  • Asklepios Klinik Altona, Hamburg

    Hamburg,
    Germany

    Site Not Available

  • University Hospital Hamburg Eppendorf

    Hamburg,
    Germany

    Site Not Available

  • University Medical Center Mannheim

    Mannheim,
    Germany

    Site Not Available

  • LMU Klinikum München

    München,
    Germany

    Active - Recruiting

  • Universitätsklinikum der Technischen Universität München

    München,
    Germany

    Site Not Available

  • University Hospital Münster

    Münster,
    Germany

    Site Not Available

  • Klinikum Nürnberg

    Nürnberg,
    Germany

    Site Not Available

  • Klinikum VEST GmbH

    Recklinghausen,
    Germany

    Site Not Available

  • Klinikum der Landeshauptstadt Stuttgart gKAöR

    Stuttgart,
    Germany

    Site Not Available

  • Hadassah-Hebrew University Medical Center

    Jerusalem,
    Israel

    Site Not Available

  • Maggiore Hospital

    Bologna,
    Italy

    Site Not Available

  • Careggi University Hospital,

    Firenze,
    Italy

    Site Not Available

  • Antonio Cardarelli Hospital

    Napoli,
    Italy

    Site Not Available

  • San Giovanni Bosco Hospital

    Torino,
    Italy

    Site Not Available

  • Amsterdam University Medical Center

    Amsterdam,
    Netherlands

    Site Not Available

  • Rijnstate Hospital Arnhem

    Arnhem,
    Netherlands

    Site Not Available

  • Haaglanden Medical Center

    Den Haag,
    Netherlands

    Site Not Available

  • University Medical Center Groningen

    Groningen,
    Netherlands

    Site Not Available

  • Leiden University Medical Center

    Leiden,
    Netherlands

    Site Not Available

  • Maastricht University Medical Center

    Maastricht,
    Netherlands

    Site Not Available

  • Radboud University Medical Center Nijmegen

    Nijmegen,
    Netherlands

    Site Not Available

  • Erasmus MC University Medical Center Rotterdam

    Rotterdam,
    Netherlands

    Site Not Available

  • Lisbon Central University Hospital

    Lisbon,
    Portugal

    Site Not Available

  • Hospital Clinico Barcelona

    Barcelona,
    Spain

    Site Not Available

  • Hospital Vall d'Hebron

    Barcelona,
    Spain

    Site Not Available

  • University Hospital Germans Trias i Pujol

    Barcelona,
    Spain

    Site Not Available

  • University Hospital Doctor Josep Trueta, Girona

    Girona,
    Spain

    Site Not Available

  • University Hospital Clínico San Carlos, Madrid

    Madrid,
    Spain

    Site Not Available

  • University Hospital Virgen de la Arrixaca, Murcia

    Murcia,
    Spain

    Site Not Available

  • Hospital Clinico Universitario de Valladolid

    Valladolid,
    Spain

    Site Not Available

  • Skane University Hospital

    Lund,
    Sweden

    Site Not Available

  • Kantonsspital Aarau, Department of Interventional and Diagnostical Neuroradiology

    Aarau, 5001
    Switzerland

    Site Not Available

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

    Basel, 4031
    Switzerland

    Site Not Available

  • Department of Neurology, University Hospital Basel

    Basel, 4031
    Switzerland

    Site Not Available

  • Inselspital Bern, University Clinic for Neuroradiology

    Bern, 3010
    Switzerland

    Site Not Available

  • Geneva University Hospitals, Interventional Neuroradiology Unit

    Genf, 1211
    Switzerland

    Site Not Available

  • Centre hospitalier universitaire vaudois, CHUV

    Lausanne, 1011
    Switzerland

    Site Not Available

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

    Lugano, 6900
    Switzerland

    Site Not Available

  • Kantonsspital Luzern

    Luzern,
    Switzerland

    Site Not Available

  • Kantonsspital St Gallen

    Saint Gallen,
    Switzerland

    Site Not Available

  • University Hospital Zurich, Departement of Neuroradiology

    Zürich, 8091
    Switzerland

    Site Not Available

  • Barts NHS Health Trust

    London,
    United Kingdom

    Site Not Available

  • University Hospitals of North Midlands NHS Trust

    Stoke-on-Trent,
    United Kingdom

    Site Not Available

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