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Magnetically Enhanced Diffusion for Acute Ischaemic Stroke (MEDIS) Trial

NCT03098732 · Status: SUSPENDED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2019-01-28

No results posted yet for this study

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.

Conditions

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

Interventions

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.

Sponsors & Collaborators

  • Pulse Therapeutics

    lead INDUSTRY

Principal Investigators

  • Keith W Muir, MBChB · University of Glasgow

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-22
Primary Completion
2019-12-31
Completion
2020-12-31
FDA Device
Yes

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03098732 on ClinicalTrials.gov