EnDovascular Therapy Plus Best Medical Treatment (BMT) Versus BMT Alone for MedIum VeSsel Occlusion sTroke
- Conditions
- Acute Ischemic Stroke
- Interventions
- Procedure: Endovascular Therapy
- Registration Number
- NCT05029414
- Lead Sponsor
- University Hospital, Basel, Switzerland
- 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 543
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention group: EVT + BMT Endovascular Therapy Patients randomized to the EVT arm will undergo endovascular therapy (EVT) in addition to best medical treatment (BMT). All decisions regarding EVT device and EVT technique will be made by the treating physician.
- Primary Outcome Measures
Name Time Method 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).
- Secondary Outcome Measures
Name Time Method Assessment of Cognitive function using the validated Montreal cognitive assessment (MoCA) at 90 days (± 14 days) after randomisation MoCA scores range between 0 and 30. A score of 26 or over is considered to be normal.
Radiologic occurrence of intracranial haemorrhages within 24 hours (± 6 hours) post randomisation Radiologic occurrence of intracranial haemorrhages graded according to the modified Safe Implementation of Thrombolysis in Stroke-Monitoring Study (SITS-MOST) definition
Change in percentage of penumbral tissue saved (Imaging Data Evaluation) at baseline and post-interventional at 24 hours (± 6 hours) post-randomisation Percentage of penumbral tissue saved (Imaging Data Evaluation): It is defined as the proportion of tissue at risk (defined as the mismatch volume derived from with RAPID Compute tomography perfusion (CTP) (IschemaView Inc.) at baseline that did not progress to infarction at 24h (derived from Magnet Resonance Imaging (MRI) (FLAIR and Diffusion Weighted Imaging (DWI)) or NCCT imaging.
Change in National Institutes of Health Stroke Scale (NIHSS) 24 hours post-randomization (+/- 6 hours) The scale is made up of 11 different elements that evaluate specific ability. The score for each ability is a number between 0 and 4, 0 being normal functioning and 4 being completely impaired. The patient's NIHSS score is calculated by adding the number for each element of the scale; 42 is the highest score possible. In the NIHSS, the higher the score, the more impaired a stroke patient is.
Change in Quality of life as assessed by the EuroQol-5D at 90 ± 14 days and at 1 year after randomisation The EQ-5D descriptive system comprises five dimensions: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression.
the descriptive system produces a 5-digit health status profile that represents that person's level of reported problems on the five EQ-5D health dimensionsPatient residential status at one year (± 30 days) after randomisation Patient residential status will be obtained through a telephone call to the patient or if not available his next of kin/caregiver one year (± 30 days) after randomisation
Degree of dependency and disability in everyday life (measured with the mRS) at one year (± 30 days) after randomisation Degree of dependency and disability in everyday life (measured with the mRS). The scale runs from 0-6, running from perfect health without symptoms (= 0) to death (= 6).
Trial Locations
- Locations (56)
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
🇩🇪Nürnberg, 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,
🇮🇹Firenze, Italy
Antonio Cardarelli Hospital
🇮🇹Napoli, Italy
San Giovanni Bosco Hospital
🇮🇹Torino, Italy
Amsterdam University Medical Center
🇳🇱Amsterdam, Netherlands
Rijnstate Hospital Arnhem
🇳🇱Arnhem, Netherlands
Haaglanden Medical Center
🇳🇱Den Haag, 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
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
🇨🇭Genf, Switzerland
Centre hospitalier universitaire vaudois, CHUV
🇨🇭Lausanne, Switzerland
Neurocentro (EOC) della Svizzera Italiana Stroke Center, Servizio di Neurologia, Ospedale Civico
🇨🇭Lugano, Switzerland
Kantonsspital Luzern
🇨🇭Luzern, Switzerland
Kantonsspital St Gallen
🇨🇭Saint Gallen, Switzerland
University Hospital Zurich, Departement of Neuroradiology
🇨🇭Zürich, Switzerland
Barts NHS Health Trust
🇬🇧London, United Kingdom
Uniklinikum Dresden
🇩🇪Dresden, Germany
Helios Klinikum Erfurt
🇩🇪Erfurt, Germany
AZ Sint-Jan Brugge
🇧🇪Brugge, Belgium
Hôpital Civil Marie Curie Charleroi
🇧🇪Charleroi, Belgium
UZ Universiteit Gent
🇧🇪Gent, Belgium
AZ Groeninge
🇧🇪Kortrijk, Belgium
Universitair Ziekenhuis Leuven
🇧🇪Leuven, Belgium
Clinique CHC MontLégia
🇧🇪Liege, 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