Magnetically Enhanced Diffusion for Acute Ischaemic Stroke (MEDIS) Trial

NCT03098732 | Suspended DMC FDA Device

• 1 other identifier: MEDIS-INT16-002
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Keywords

Stroke; Ischemic; Tissue Plasminogen Activator; Thrombolysis; Vascular Diseases; Cerebrovascular Disorders; Fibrinolytic Agents; Plasminogen

Outcome Measures

Primary Outcomes (2)

• Primary Performance: Early Recanalisation 60 +/- 30 minutes after IV tPA completion

  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.

  60 +/- 30 minutes after completion of IV tPA administration.

• Primary Safety: Incidence of Symptomatic Type 2 Parenchymal (PH-2) Haemorrhagic Transformation

  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.

  24 ± 6 Hours after treatment

Secondary Outcomes (2)

• 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

Study Arms (2)

Magnetically Enhanced Diffusion (MED)

EXPERIMENTAL

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).

Device: Magnetically Enhanced Diffusion (MED)

MED Workstation Magnet Sham Control

SHAM COMPARATOR

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).

Device: MED Workstation Magnet Sham Control

Interventions

Magnetically Enhanced Diffusion (MED) DEVICE

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

Also known as: MED Workstation, MED MicroBeads

Magnetically Enhanced Diffusion (MED)

MED Workstation Magnet Sham Control DEVICE

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

MED Workstation Magnet Sham Control

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 and \<85
• Clinical signs consistent with acute ischaemic stroke
• Prestroke functional independence (prestroke Modified Rankin Score ≤2)
• NIHSS 4-25 at the time of randomisation
• 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.
• 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.

You may not qualify if:

• The subject is likely to receive intra-arterial (IA) intervention.
• 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.
• Current participation or participation in the last 4 weeks in another investigational drug or device treatment study.
• Life expectancy of less than 90 days due to other medical condition.
• Subject with a pre-existing neurological or psychiatric disease that would confound the neurological and functional evaluations.
• 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).
• Subject has recently (within 30 days) received iron replacement therapy or iron based MR contrast.
• Subject has known or suspected liver disease, including hepatitis and/or cirrhosis.
• Computed tomography (CT) or MRI evidence of haemorrhage on presentation.
• CT or MRI evidence of mass effect or intra-cranial tumour (except small meningioma).

Sponsors & Collaborators

• Pulse Therapeutics: lead

Study Sites (2)

Queen Elizabeth University Hospital

Glasgow, Scotland, G51 4TF, United Kingdom

Location

Countess of Chester Hospital NHS Foundation Trust

Chester, CH2 1UL, United Kingdom

Location

MeSH Terms

Conditions

Stroke; Ischemic Stroke; Infarction, Middle Cerebral Artery; Thrombotic Stroke; Nervous System Diseases; Cerebrovascular Disorders; Intracranial Embolism and Thrombosis; Ischemia; Vascular Diseases

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Cardiovascular Diseases; Cerebral Infarction; Brain Infarction; Brain Ischemia; Cerebral Arterial Diseases; Intracranial Arterial Diseases; Infarction; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Thromboembolism; Embolism and Thrombosis

Study Officials

• Keith W Muir, MBChB

  University of Glasgow

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.)

Study Record Dates

• First Submitted: March 17, 2017
• First Posted: April 4, 2017
• Study Start: March 22, 2017
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2020
• Last Updated: January 28, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)