EnDovascular Therapy Plus Best Medical Treatment (BMT) Versus BMT Alone for MedIum VeSsel Occlusi… (NCT05029414) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
EnDovascular Therapy Plus Best Medical Treatment (BMT) Versus BMT Alone for MedIum VeSsel Occlusion sTroke
Belgium543 participantsStarted 2021-12-09
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 nega…
What they're measuring
1
Degree of dependency and disability in everyday life (measured with the mRS)
Timeframe: at 90 days (± 14 days) after randomisation