Magnetically Enhanced Diffusion for Acute Ischaemic Stroke (MEDIS) Trial
Stopped: Strategic hold
United Kingdom120 participantsStarted 2017-03-22
Plain-language 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.
Who can participate
Age range18 Years – 85 Years
SexALL
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Inclusion criteria
✓. Age ≥18 and \<85
✓. Clinical signs consistent with acute ischaemic stroke
✓. Initiation of IV tPA (alteplase or tissue Plasminogen Activator) within the locally approved time window from stroke symptom onset (onset time is defined as the last time when the subject was witnessed to be at baseline).
✓. Arterial Occlusive Lesion (mAOL ≤1) in the M1 or M2 segments of the MCA (Middle Cerebral Artery) or carotid terminus confirmed by CT angiography.
✓. Subject is able to start the MED procedure within 15 +10 minutes) from the t-PA IV infusion, and complete 60+15 minutes of MED procedure treatment.
✓. Subject or subject's legally authorised representative has signed and dated an Informed Consent Form according to country regulations, ethics committee, and/or Institutional Review Board requirements.
Exclusion criteria
What they're measuring
1
Primary Performance: Early Recanalisation 60 +/- 30 minutes after IV tPA completion
Timeframe: 60 +/- 30 minutes after completion of IV tPA administration.
2
Primary Safety: Incidence of Symptomatic Type 2 Parenchymal (PH-2) Haemorrhagic Transformation
✕. The subject is likely to receive intra-arterial (IA) intervention.
✕. Standard exclusions for thrombolysis according to the approved label and local institutional protocols.
✕. Female who is pregnant or lactating or has a positive pregnancy test at time of admission.
✕. Rapid neurological improvement prior to study randomisation suggesting resolution of the occlusion.
✕. Known hyper-sensitivity to radiographic contrast agents.
✕. Known hyper-sensitivity to iron-based agents or polyethylene glycol.
✕. Known or suspected symptomatic haemosiderosis or haemochromatosis.
✕. Has a previous or existing cardiovascular condition resulting in history of heart block, tachybrady syndrome, symptomatic postural hypotension requiring medical intervention.