Magnetically Enhanced Diffusion for Acute Ischaemic Stroke (MEDIS) Trial (MEDIS)
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|ClinicalTrials.gov Identifier: NCT03098732|
Recruitment Status : Suspended (Strategic hold)
First Posted : April 4, 2017
Last Update Posted : January 28, 2019
|Condition or disease||Intervention/treatment||Phase|
|Stroke, Acute Stroke, Ischemic Infarction, Middle Cerebral Artery Strokes Thrombotic Neurologic Disorder Cerebrovascular Disorders Intracranial Embolism and Thrombosis||Device: Magnetically Enhanced Diffusion (MED) Device: MED Workstation Magnet Sham Control||Not Applicable|
The study is a global, multicentre prospective, randomised, single blind, blinded endpoint study comparing rates of early recanalisation (defined by mAOL) in Acute Ischaemic Stroke (AIS) subjects with visible occlusion who are treated with either IV tPA plus sham device or IV tPA in combination with the MED System procedure.
The study population will be randomised 1:1 into two arms:
- A Sham Control Group (SCG) and an
- Experimental Treatment Group (ETG).
The ETG will receive IV tPA and the complete MED System procedure consisting of MED MicroBeads and the MED Workstation magnet procedure. The SCG will not receive MED MicroBeads while the MED Workstation will be activated as a Sham control. Subjects will be blinded to treatment arm. Stratification will be performed based upon baseline age and location of the occlusion (Middle Cerebral Artery segments M1, M2, or Carotid Terminus).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Subjects will be randomized 1:1 to receive active treatment or sham. Enrollment will be stratified based upon age (<75 or >/=75) and location of the occlusion (M1, M2 or carotid terminus.)|
|Masking:||Double (Participant, Outcomes Assessor)|
Subjects will be masked with regard to treatment group. Imaging data will be evaluated by independent readers (2) blinded to treatment allocation.
Neurological outcomes will be measured at the 90 Day visit by evaluators blinded to treatment allocation.
|Official Title:||A Prospective International Multicentre Randomised Controlled Single Blind Clinical Investigation of Magnetically Enhanced Diffusion for Acute Ischaemic Stroke (MEDIS)|
|Actual Study Start Date :||March 22, 2017|
|Estimated Primary Completion Date :||December 31, 2019|
|Estimated Study Completion Date :||December 31, 2020|
Experimental: Magnetically Enhanced Diffusion (MED)
The Experimental Treatment will receive the complete MED System Procedure consisting of MED MicroBeads and the MED Workstation magnet procedure for 60 minutes in addition to IV tissue plasminogen activator (tPA or Alteplase).
Device: Magnetically Enhanced Diffusion (MED)
Treatment of Acute Ischemic Stroke with IV tPA and the adjunctive Magnetically Enhanced Diffusion (MED) System Procedure.
Sham Comparator: MED Workstation Magnet Sham Control
The MED Workstation Magnet Sham Comparator will not receive MED MicroBeads while the MED Workstation Magnet will be activated as a Sham control for 60 minutes in addition to IV tissue plasminogen activator (tPA or Alteplase).
Device: MED Workstation Magnet Sham Control
Treatment of Acute Ischemic Stroke with IV tPA and Sham use of the MED Workstation only, without the injection of MED MicroBeads.
- Primary Performance: Early Recanalisation 60 +/- 30 minutes after IV tPA completion [ Time Frame: 60 +/- 30 minutes after completion of IV tPA administration. ]Early recanalisation (Arterial Occlusive Lesion [mAOL] score) assessed from a blinded evaluation of Computed Tomographic Angiography (CTA) imaging of the primary lesion 60+/- 30 minutes after completion of tPA infusion. An ordinal shift analysis of the mAOL score distribution between the Sham Control and MED System Procedure arms will be conducted.
- Primary Safety: Incidence of Symptomatic Type 2 Parenchymal (PH-2) Haemorrhagic Transformation [ Time Frame: 24 ± 6 Hours after treatment ]Incidence of symptomatic PH-2 haemorrhagic transformation at 24 ± 6 hours post randomisation as determined by NCCT combined with a neurological deterioration that includes an increase of 4 points or more on the NIHSS from baseline or the lowest NIHSS value between baseline and 24 hours, or leading to death.
- Secondary Clinical Performance Endpoint: Neurological outcome mRS at 90 days [ Time Frame: 90 days after randomisation ]Neurological outcome as defined by modified Rankin score (mRS) at 90 days.
- Secondary Technical Clinical Performance Endpoint: Cerebral Infarct volume at 24 Hours [ Time Frame: 24 ± 6 hours after randomisation ]Volume of cerebral infarction as measured by Non-Contrast Computed Tomography (NCCT) at 24 ± 6 hours post randomisation.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03098732
|Queen Elizabeth University Hospital|
|Glasgow, Scotland, United Kingdom, G51 4TF|
|Countess of Chester Hospital NHS Foundation Trust|
|Chester, United Kingdom, CH2 1UL|
|Principal Investigator:||Keith W Muir, MBChB||University of Glasgow|