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.
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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
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).
Trial sites (56)
Facility
City
Region
Status
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
+ 16 more sites — see the full list on the official registry below.
More University Hospital, Basel, Switzerland trials in the Netherlands
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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