Clinical Trial: Magnetically Enhanced Diffusion for Acute Ischaemic Stroke (MEDIS) Trial

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Prospective International Multicentre Randomised Controlled Single Blind Clinical Investigation of Magnetically Enhanced Diffusion for Acute Ischaemic Stroke (MEDIS)

Brief Summary: 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 Summary:

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).


Sponsor: Pulse Therapeutics

Current Primary Outcome:

  • 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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.


Original Secondary Outcome: Same as current

Information By: Pulse Therapeutics

Dates:
Date Received: March 17, 2017
Date Started: March 22, 2017
Date Completion: October 31, 2018
Last Updated: March 27, 2017
Last Verified: March 2017