EnDovascular therapy plus best medical treatment (BMT) versus BMT alone for MedIum VeSsel Occlusion sTroke - a prAgmatic, international, multicentre, randomized triaL (DISTAL) - DISTA

niversity Hospital Basel0 个研究点目标入组 100 人开始时间: 待定最近更新: 2024年4月9日

适应症

试验速览

暂无简介。

•1. Acute ischemic stroke
•2. Treatment (arterial puncture) can be initiated
•2.1. Within 6 hours of last seen well (LSW)
•2.2. Within 6 to 24 hours of LSW AND
•CT Criteria: Evidence of a hypoperfusion-hypodensity mismatch (Absence of
•hypodensity on the non-contrast 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)
•3. Isolated medium vessel occlusion (i.e. an occlusion of the co-/non-dominant
•M2, the M3/M4 segment of the MCA, the A1/A2/A3 segment of the ACA or the P1/P2
•segment of the PCA) confirmed by CT or MRI Angiography
•4. National Institute of Health Stroke Scale (NIHSS) Score of >= 4 points or
•symptoms deemed clearly disabling by treating physician (i.e. aphasia,
•hemianopia, etc.)
•5. Age >=18 years
•6. Deferred Written informed consent.
•7. Agreement of treating physician to perform endovascular procedure

•1. Acute intracranial haemorrhage
•2. Patient bedridden or presenting from a nursing home
•3. In-Hospital Stroke
•4. Known (serious) sensitivity to radiographic contrast agents, nickel,
•titanium metals or their alloys
•5. Foreseeable difficulties in follow-up due to geographic reasons (e.g.
•patients living abroad)
•6. Evidence of an ongoing pregnancy prior to randomization. A negative
•pregnancy test before randomisation is required for all women with
•child-bearing potential.
•7. 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
•8. Known, severe comorbidities, which will likely prevent improvement or
•follow-up (active cancer, alcohol/drug abuse or dementia)
•9. Radiological confirmed evidence of mass effect or intracranial tumour
•(except small meningioma)
•10. Radiological confirmed evidence of cerebral vasculitis
•11. Evidence of vessel recanalization prior to randomisation
•12. Participation in another interventional trial

发起方

niversity Hospital Basel