Stroke, AcuteMEDISNCT03098732
Magnetically Enhanced Diffusion for Acute Ischaemic Stroke (MEDIS) Trial
A study testing Magnetically Enhanced Diffusion (MED) in people with Stroke, Acute and Stroke, Ischemic, run by Pulse Therapeutics at 2 sites in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Stroke, Acute, Stroke, Ischemic, Infarction, Middle Cerebral Artery
- What is being tested?
- Magnetically Enhanced Diffusion (MED)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 22 Mar 2017to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 9Show fewer
- 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.
Who cannot join
- 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.
Show all 19Show fewer
- 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.
- Imaging Exclusion Criteria:
- Computed tomography (CT) or MRI evidence of haemorrhage on presentation.
- Exclusion: Large core of ischemia defined as NCCT ASPECTS 4 or less.
- CT or MRI evidence of mass effect or intra-cranial tumour (except small meningioma).
- CTA or MRA (CT or MR Angiography) evidence of carotid dissection or complete cervical carotid occlusion.
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Countess of Chester Hospital NHS Foundation Trust
Chester, CH2 1UL
Queen Elizabeth University Hospital
Glasgow, Scotland, G51 4TF
About this study
Official title: A Prospective International Multicentre Randomised Controlled Single Blind Clinical Investigation of Magnetically Enhanced Diffusion for Acute Ischaemic Stroke (MEDIS)
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.
Read the 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
- Being tested
- Magnetically Enhanced Diffusion (MED), MED Workstation Magnet Sham Control
- Keywords
- Stroke, Ischemic, Tissue Plasminogen Activator, Thrombolysis, Vascular Diseases, Cerebrovascular Disorders, Fibrinolytic Agents, Plasminogen
- Medical subject headings
- Stroke, Ischemic Stroke, Infarction, Middle Cerebral Artery, Thrombotic Stroke, Nervous System Diseases, Cerebrovascular Disorders, Intracranial Embolism and Thrombosis, Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetically Enhanced Diffusion (MED)Device
Also called MED Workstation, MED MicroBeads
Treatment of Acute Ischemic Stroke with IV tPA and the adjunctive Magnetically Enhanced Diffusion (MED) System Procedure.
MED Workstation Magnet Sham ControlDevice
Treatment of Acute Ischemic Stroke with IV tPA and Sham use of the MED Workstation only, without the injection of MED MicroBeads.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Device: MED Workstation Magnet Sham Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 24 ± 6 Hours after treatment
Secondary outcomes (2)
Secondary Clinical Performance Endpoint: Neurological outcome mRS at 90 days
Neurological outcome as defined by modified Rankin score (mRS) at 90 days.
Measured: 90 days after randomisation
Secondary Technical Clinical Performance Endpoint: Cerebral Infarct volume at 24 Hours
Volume of cerebral infarction as measured by Non-Contrast Computed Tomography (NCCT) at 24 ± 6 hours post randomisation.
Measured: 24 ± 6 hours after randomisation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2017
- Study start22 Mar 2017
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Dec 2020 (estimated)
Why it stopped: Strategic hold
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.)
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pulse Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Keith W Muir, MBChB, Principal investigator, University of Glasgow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03098732
- Sponsor's protocol ID
- MEDIS-INT16-002
- Acronym
- MEDIS
- Status last verified
- Jan 2019
- First submitted
- 17 Mar 2017
- Last updated
- 28 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective International Multicentre Randomised Controlled Single Blind Clinical Investigation of Magnetically Enhanced Diffusion for Acute Ischaemic Stroke (MEDIS)
- ClinicalTrials.gov ID
- NCT03098732
- Acronym / sponsor ID
- MEDIS / MEDIS-INT16-002
- Conditions
- Stroke, Acute, Stroke, Ischemic, Infarction, Middle Cerebral Artery, Strokes Thrombotic, Neurologic Disorder, Cerebrovascular Disorders
- Keywords
- Stroke, Ischemic, Tissue Plasminogen Activator, Thrombolysis, Vascular Diseases, Cerebrovascular Disorders, Fibrinolytic Agents, Plasminogen
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Strategic hold
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Pulse TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 22 Mar 2017 (actual)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 4 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- 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.)
| Arm | Type | Receives |
|---|---|---|
| Magnetically Enhanced Diffusion (MED) | Experimental | Device: Magnetically Enhanced Diffusion (MED)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). |
| MED Workstation Magnet Sham Control | Sham comparator | Device: MED Workstation Magnet Sham ControlThe 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). |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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).
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnetically Enhanced Diffusion (MED)Also: MED Workstation, MED MicroBeadsTreatment of Acute Ischemic Stroke with IV tPA and the adjunctive Magnetically Enhanced Diffusion (MED) System Procedure. | Device | Magnetically Enhanced Diffusion (MED) |
| MED Workstation Magnet Sham ControlTreatment of Acute Ischemic Stroke with IV tPA and Sham use of the MED Workstation only, without the injection of MED MicroBeads. | Device | MED Workstation Magnet Sham Control |
Primary outcome
Primary Performance: Early Recanalisation 60 +/- 30 minutes after IV tPA completion
Time frame: 60 +/- 30 minutes after completion of IV tPA administration.
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.
Primary Safety: Incidence of Symptomatic Type 2 Parenchymal (PH-2) Haemorrhagic Transformation
Time frame: 24 ± 6 Hours after treatment
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.
2 secondary outcomes
Secondary Clinical Performance Endpoint: Neurological outcome mRS at 90 days
Time frame: 90 days after randomisation
Secondary Technical Clinical Performance Endpoint: Cerebral Infarct volume at 24 Hours
Time frame: 24 ± 6 hours after randomisation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2019.
- Individual participant dataSharing planned: No
Related trials for Stroke, Acute
Recruiting
Delay AvoIding Primary Evaluation for ThRombectomy of Acute StrokE Patients With Large Vessel OCclusion in the Angiography SuiTe
Stroke, Acute
RecruitingObservational study
Implementing Transcranial Direct Current Stimulation in a Rehabilitation Setting
Aphasia, Stroke
RecruitingObservational study
Natural History of Stroke: Cause and Development
Brain Disease, Ischemic Attack, Transient
Not yet recruiting
Prehospital Response and Emergency Stroke Transport Optimisation
Acute Ischemic Stroke
Active, not recruitingObservational study
Focused Intensive Repeated Stepping During Inpatient Rehabilitation Poststroke - A Quality Improvement Project
Stroke, Acute, Gait, Hemiplegic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Keith W Muir, MBChB principal investigator
University of Glasgow
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnetically Enhanced Diffusion (MED) in people with Stroke, Acute and Stroke, Ischemic, run by Pulse Therapeutics at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 28 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Performance: Early Recanalisation 60 +/- 30 minutes after IV tPA completion (time frame: 60 +/- 30 minutes after completion of IV tPA administration.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2019.