NCT03098732

Magnetically Enhanced Diffusion for Acute Ischaemic Stroke (MEDIS) Trial

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

• Status: Suspended
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Pulse Therapeutics · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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 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

• Stroke, Acute
• Stroke, Ischemic
• Infarction, Middle Cerebral Artery
• Strokes Thrombotic
• Neurologic Disorder
• Cerebrovascular Disorders
• Intracranial Embolism and Thrombosis

Interventions

Type	Name	Description
DEVICE	Magnetically Enhanced Diffusion (MED)	Treatment of Acute Ischemic Stroke with IV tPA and the adjunctive Magnetically Enhanced Diffusion (MED) System Procedure.
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.

Timeline

• Start date: 2017-03-22
• Primary completion: 2019-12-31
• Completion: 2020-12-31
• First posted: 2017-04-04
• Last updated: 2019-01-28

Locations

2 sites across 1 country: United Kingdom

Regulatory

• FDA-regulated device study