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Trial record 18 of 66 for:    "cerebral autosomal recessive arteriopathy with subcortical infarcts and leukoencephalopathy" OR "Cerebral Arterial Diseases"

Magnetically Enhanced Diffusion for Acute Ischaemic Stroke (MEDIS) Trial (MEDIS)

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ClinicalTrials.gov Identifier: NCT03098732
Recruitment Status : Recruiting
First Posted : April 4, 2017
Last Update Posted : April 4, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Stroke, Acute Stroke, Ischemic Infarction, Middle Cerebral Artery Strokes Thrombotic Neurologic Disorder Cerebrovascular Disorders Intracranial Embolism and Thrombosis Device: Magnetically Enhanced Diffusion (MED) Device: MED Workstation Magnet Sham Control Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
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.)
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.

Primary Purpose: Treatment
Official Title: A Prospective International Multicentre Randomised Controlled Single Blind Clinical Investigation of Magnetically Enhanced Diffusion for Acute Ischaemic Stroke (MEDIS)
Actual Study Start Date : March 22, 2017
Estimated Primary Completion Date : July 31, 2018
Estimated Study Completion Date : October 31, 2018

Arm Intervention/treatment
Experimental: 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).
Device: Magnetically Enhanced Diffusion (MED)
Treatment of Acute Ischemic Stroke with IV tPA and the adjunctive Magnetically Enhanced Diffusion (MED) System Procedure.
Other Names:
  • MED Workstation
  • MED MicroBeads

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




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. Secondary Clinical Performance Endpoint: Neurological outcome mRS at 90 days [ Time Frame: 90 days after randomisation ]
    Neurological outcome as defined by modified Rankin score (mRS) at 90 days.

  2. Secondary Technical Clinical Performance Endpoint: Cerebral Infarct volume at 24 Hours [ Time Frame: 24 ± 6 hours after randomisation ]
    Volume of cerebral infarction as measured by Non-Contrast Computed Tomography (NCCT) at 24 ± 6 hours post randomisation.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03098732


Contacts
Contact: Kay O Broschat, PhD 314-724-9644 kob@pulsetherapeutics.com
Contact: Sean C Morris, BS 518-944-3367 scm@pulsetherapeutics.com

Locations
United Kingdom
Queen Elizabeth University Hospital Recruiting
Glasgow, Scotland, United Kingdom, G51 4TF
Contact: Keith W Muir, MD    +44 (0)141 451 5874    Keith.Muir@glasgow.ac.uk   
Principal Investigator: Keith W Muir, MD         
Countess of Chester Hospital NHS Foundation Trust Recruiting
Chester, United Kingdom, CH2 1UL
Contact: Sandra Leeson         
Principal Investigator: Kausik Chatterjee, MD         
University College London Hospitals NHS Foundation Trust Recruiting
London, United Kingdom, WC1B 5EH
Contact: Renuka Erande         
Principal Investigator: Richard Perry, BM, BCh, MA, PhD, MRCP         
Sub-Investigator: Robert Simister, MA, FRCP, PhD         
Salford Royal NHS Foundation Trust Recruiting
Salford, United Kingdom, M6 8HD
Contact: Drew Norwood-Green         
Principal Investigator: Craig J Smith, MBChB MD MRCP         
Sponsors and Collaborators
Pulse Therapeutics
Investigators
Principal Investigator: Keith W Muir, MBChB University of Glasgow

Responsible Party: Pulse Therapeutics
ClinicalTrials.gov Identifier: NCT03098732     History of Changes
Other Study ID Numbers: MEDIS-INT16-002
First Posted: April 4, 2017    Key Record Dates
Last Update Posted: April 4, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Pulse Therapeutics:
Stroke
Ischemic
Tissue Plasminogen Activator
Thrombolysis
Vascular Diseases
Cerebrovascular Disorders
Fibrinolytic Agents
Plasminogen

Additional relevant MeSH terms:
Cerebral Arterial Diseases
Disease
Stroke
Ischemia
Infarction
Thrombosis
Embolism
Cerebrovascular Disorders
Embolism and Thrombosis
Nervous System Diseases
Intracranial Embolism
Infarction, Middle Cerebral Artery
Intracranial Embolism and Thrombosis
Pathologic Processes
Brain Diseases
Central Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Necrosis
Thromboembolism
Cerebral Infarction
Brain Infarction
Brain Ischemia
Intracranial Arterial Diseases
Plasminogen
Tissue Plasminogen Activator
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action