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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
543
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.
Degree of dependency and disability in everyday life (measured with the mRS)
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).
Time frame: at 90 days (± 14 days) after randomisation
Change in National Institutes of Health Stroke Scale (NIHSS)
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.
Time frame: 24 hours post-randomization (+/- 6 hours)
Assessment of Cognitive function using the validated Montreal cognitive assessment (MoCA)
MoCA scores range between 0 and 30. A score of 26 or over is considered to be normal.
Time frame: at 90 days (± 14 days) after randomisation
Change in Quality of life as assessed by the EuroQol-5D
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 dimensions
Time frame: at 90 ± 14 days and at 1 year after randomisation
Degree of dependency and disability in everyday life (measured with the mRS)
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).
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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
...and 46 more locations
Time frame: at one year (± 30 days) after randomisation
Patient residential status
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
Time frame: at one year (± 30 days) after randomisation
Change in percentage of penumbral tissue saved (Imaging Data Evaluation)
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.
Time frame: at baseline and post-interventional at 24 hours (± 6 hours) post-randomisation
Radiologic occurrence of intracranial haemorrhages
Radiologic occurrence of intracranial haemorrhages graded according to the modified Safe Implementation of Thrombolysis in Stroke-Monitoring Study (SITS-MOST) definition
Time frame: within 24 hours (± 6 hours) post randomisation