Magnetically Enhanced Diffusion for Acute Ischaemic Stroke (MEDIS) Trial "MEDIS"

Recruiting

Phase N/A Results N/A

Trial Description

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.

Detailed Description

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).

Conditions

Interventions

  • 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).

Outcomes

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

Sponsors