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)

Sponsors

Lead Sponsor: Pulse Therapeutics

Source Pulse Therapeutics
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 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).

Overall Status Suspended
Start Date 2017-03-22
Completion Date 2020-12-31
Primary Completion Date 2019-12-31
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Primary Performance: Early Recanalisation 60 +/- 30 minutes after IV tPA completion 60 +/- 30 minutes after completion of IV tPA administration.
Primary Safety: Incidence of Symptomatic Type 2 Parenchymal (PH-2) Haemorrhagic Transformation 24 ± 6 Hours after treatment
Secondary Outcome
Measure Time Frame
Secondary Clinical Performance Endpoint: Neurological outcome mRS at 90 days 90 days after randomisation
Secondary Technical Clinical Performance Endpoint: Cerebral Infarct volume at 24 Hours 24 ± 6 hours after randomisation
Enrollment 120
Condition
Intervention

Intervention Type: Device

Intervention Name: Magnetically Enhanced Diffusion (MED)

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

Arm Group Label: Magnetically Enhanced Diffusion (MED)

Intervention Type: Device

Intervention Name: MED Workstation Magnet Sham Control

Description: Treatment of Acute Ischemic Stroke with IV tPA and Sham use of the MED Workstation only, without the injection of MED MicroBeads.

Arm Group Label: MED Workstation Magnet Sham Control

Eligibility

Criteria:

Inclusion Criteria: 1. Age ≥18 and <85 2. Clinical signs consistent with acute ischaemic stroke 3. Prestroke functional independence (prestroke Modified Rankin Score ≤2) 4. NIHSS 4-25 at the time of randomisation 5. 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). 6. Arterial Occlusive Lesion (mAOL ≤1) in the M1 or M2 segments of the MCA (Middle Cerebral Artery) or carotid terminus confirmed by CT angiography. 7. 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. 8. 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. 9. It is the enrolling Investigator's or designee's opinion based upon the knowledge of the Subject's condition as well as the features of the MED device, that the Subject is an appropriate candidate for stroke management utilizing MED. Exclusion Criteria: 1. The subject is likely to receive intra-arterial (IA) intervention. 2. Standard exclusions for thrombolysis according to the approved label and local institutional protocols. 3. Female who is pregnant or lactating or has a positive pregnancy test at time of admission. 4. Rapid neurological improvement prior to study randomisation suggesting resolution of the occlusion. 5. Known hyper-sensitivity to radiographic contrast agents. 6. Known hyper-sensitivity to iron-based agents or polyethylene glycol. 7. Known or suspected symptomatic haemosiderosis or haemochromatosis. 8. Has a previous or existing cardiovascular condition resulting in history of heart block, tachybrady syndrome, symptomatic postural hypotension requiring medical intervention. 9. Current participation or participation in the last 4 weeks in another investigational drug or device treatment study. 10. Life expectancy of less than 90 days due to other medical condition. 11. Subject with a pre-existing neurological or psychiatric disease that would confound the neurological and functional evaluations. 12. Subject has contraindications to Magnetic Resonance Imaging (MR; examples include, but are not limited to, an implantable cardioverter defibrillator, pacemaker, clipped or coiled aneurysm, neurostimulator). 13. Subject has recently (within 30 days) received iron replacement therapy or iron based MR contrast. 14. Subject has known or suspected liver disease, including hepatitis and/or cirrhosis. Imaging Exclusion Criteria: 1. Computed tomography (CT) or MRI evidence of haemorrhage on presentation. 2. Exclusion: Large core of ischemia defined as NCCT ASPECTS 4 or less. 3. CT or MRI evidence of mass effect or intra-cranial tumour (except small meningioma). 4. CTA or MRA (CT or MR Angiography) evidence of carotid dissection or complete cervical carotid occlusion.

Gender:

All

Minimum Age:

18 Years

Maximum Age:

85 Years

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Keith W Muir, MBChB Principal Investigator University of Glasgow
Location
Facility:
Queen Elizabeth University Hospital | Glasgow, Scotland, G51 4TF, United Kingdom
Countess of Chester Hospital NHS Foundation Trust | Chester, CH2 1UL, United Kingdom
Location Countries

United Kingdom

Verification Date

2019-01-01

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Magnetically Enhanced Diffusion (MED)

Type: Experimental

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).

Label: MED Workstation Magnet Sham Control

Type: Sham Comparator

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).

Acronym MEDIS
Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Intervention Model Description: Subjects will be randomized 1:1 to receive active treatment or sham. Enrollment will be stratified based upon age (<75 or >/=75) and location of the occlusion (M1, M2 or carotid terminus.)

Primary Purpose: Treatment

Masking: Double (Participant, Outcomes Assessor)

Masking Description: Subjects will be masked with regard to treatment group. Imaging data will be evaluated by independent readers (2) blinded to treatment allocation. Neurological outcomes will be measured at the 90 Day visit by evaluators blinded to treatment allocation.

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