The objective of the MEDIS study is to determine if subjects experiencing an Acute Ischaemic Stroke due to large vessel occlusion, treated with IV tPA combined with the MED procedure have a greater likelihood of recanalisation 30-90 minutes after the completion of tPA infusion than subjects treated with IV tPA (plus sham device). Safety of the MED System Procedure will be evaluated by the incidence of symptomatic PH-2 haemorrhagic transformation within 24 hours following the procedure. Lastly, a health economics study will be conducted to estimate health care costs for each treatment.
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).
- Stroke, Acute
- Cerebrovascular Disorders
- Infarction, Middle Cerebral Artery
- Stroke, Ischemic
- Strokes Thrombotic
- Neurologic Disorder
- Intracranial Embolism and Thrombosis
- Magnetically Enhanced Diffusion (MED) Device
Other Names: MED Workstation; MED MicroBeads Intervention Desc: Treatment of Acute Ischemic Stroke with IV tPA and the adjunctive Magnetically Enhanced Diffusion (MED) System Procedure. ARM 1: Kind: Experimental Label: Magnetically Enhanced Diffusion (MED) Description: 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).
- MED Workstation Magnet Sham Control Device
Intervention Desc: Treatment of Acute Ischemic Stroke with IV tPA and Sham use of the MED Workstation only, without the injection of MED MicroBeads. ARM 1: Kind: Experimental Label: MED Workstation Magnet Sham Control Description: 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).
|Type||Measure||Time Frame||Safety Issue|
|Primary||Primary Performance: Early Recanalisation 60 +/- 30 minutes after IV tPA completion||60 +/- 30 minutes after completion of IV tPA administration.|
|Primary||Primary Safety: Incidence of Symptomatic Type 2 Parenchymal (PH-2) Haemorrhagic Transformation||24 ± 6 Hours after treatment|
|Secondary||Secondary Clinical Performance Endpoint: Neurological outcome mRS at 90 days||90 days after randomisation|
|Secondary||Secondary Technical Clinical Performance Endpoint: Cerebral Infarct volume at 24 Hours||24 ± 6 hours after randomisation|
- Pulse Therapeutics Lead