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MIND: Artemis in the Removal of Intracerebral Hemorrhage

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03342664
Recruitment Status : Recruiting
First Posted : November 17, 2017
Last Update Posted : June 7, 2023
Sponsor:
Information provided by (Responsible Party):
Penumbra Inc.

Study Description
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Brief Summary:
The primary objective of this multicenter randomized controlled study is to compare the safety and efficacy of minimally invasive hematoma evacuation with the Artemis Neuro Evacuation Device to best medical management for the treatment of intracerebral hemorrhage (ICH).

Condition or disease Intervention/treatment Phase
Cerebral Hemorrhage Brain Hemorrhage Cerebral Parenchymal Hemorrhage Intracerebral Hemorrhage Device: Artemis + Medical Management Other: Best Medical Management Alone (MM) Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Subjects will be randomized to either minimally invasive hematoma evacuation with the Artemis Neuro Evacuation Device with medical management (MIS group) or best medical management alone (2:1) (MM).
Masking: Single (Outcomes Assessor)
Masking Description: 180 day mRS is blinded
Primary Purpose: Treatment
Official Title: MIND: A Prospective, Multicenter Study of Artemis a Minimally Invasive Neuro Evacuation Device, in the Removal of Intracerebral Hemorrhage
Actual Study Start Date : February 7, 2018
Estimated Primary Completion Date : January 2028
Estimated Study Completion Date : January 2029

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Arms and Interventions
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Arm Intervention/treatment
Experimental: Artemis + Medical Management (MIS)
Minimally invasive hematoma evacuation with the Artemis Neuro Evacuation Device with medical management
 Device: Artemis + Medical Management
Subject will receive best MM in addition to the MIS procedure with Artemis.
Other Name: MIS + MM
Active Comparator: Best Medical Management Alone (MM)
Best medical management alone per standard of care at treating institution
 Other: Best Medical Management Alone (MM)
Subject will receive best MM for ICH as determined by stroke physician following AHA/ESO guidelines.
Other Names:
  • MM
  • Control


Outcome Measures
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Primary Outcome Measures :
  1. Global disability (functional outcome) assessed via the ordinal modified Rankin score (mRS) [ Time Frame: 180 days ]
    (0 no symptoms - 5 severe disability)

  2. Rate of mortality [ Time Frame: 30 days ]

Secondary Outcome Measures :
  1. Functional outcomes measured via weighted modified Rankin Score (mRS) [ Time Frame: 180 days ]
    (0 no symptoms - 5 severe disability)

  2. Functional outcomes measured via modified Rankin Score (mRS) [ Time Frame: 365 days ]
    (0 no symptoms - 5 severe disability)

  3. Quality of life assessed via Stroke Impact Scale [ Time Frame: 180 and 365 days ]
    Measures mobility and activities of daily living

  4. Quality of life assessed via EQ-5D-5L [ Time Frame: 180 and 365 days ]
    Self assessment on activities of daily living

  5. Length of hospital stay [ Time Frame: Admission to hospital discharge (up to one year) ]
  6. Length of ICU [ Time Frame: # of days from admission (up to one year) ]
  7. Length of procedure [ Time Frame: Time in minutes at the time of surgery (up to one day) ]
  8. Functional outcomes measured via modified Rankin Score (mRS) of ≤ 3 [ Time Frame: 180 days ]
    (0 no symptoms - 5 severe disability)

  9. Functional outcomes measured via modified Rankin Score (mRS) of ≤ 2 [ Time Frame: 180 days ]
    (0 no symptoms - 5 severe disability)


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patient age ≥ 18 and ≤ 80
  2. Supratentorial ICH of volume ≥ 20 and ≤ 80 cc (measured using A x B X C/2 method)
  3. Hemostasis as confirmed by no arterial spot sign (may perform additional scan(s) every 6 hours to demonstrate hemostasis)
  4. NIHSS ≥ 6
  5. GCS ≥ 5 and ≤ 15
  6. Historical mRS 0 or 1
  7. Symptom onset < 24 hours prior to initial CT/MR
  8. MIS must be initiated within 72 hours of ictus/bleed
  9. SBP must be < 180 mmHg and controlled at this level for at least 6 hours

Exclusion Criteria:

  1. Imaging

    1. "Arterial Spot Sign" identified on final CTA indicating expanding hemorrhage
    2. Hemorrhagic lesion such as a vascular malformation (cavernous malformation, AVM etc.), aneurysm, and/or neoplasm
    3. Hemorrhagic conversion of an underlying ischemic stroke
    4. Infratentorial hemorrhage
    5. Primary thalamic ICH (where the center of the hemorrhage emulates from the thalamus)
    6. Associated intra-ventricular hemorrhage requiring treatment for IVH-related mass effect or shift due to trapped ventricle (EVD for ICP management is allowed)
    7. Midbrain extension/involvement
    8. Absolute contraindication to CTA, conventional angiography and MRA

  2. Coagulation Issues

    1. Absolute requirement for long-term anti-coagulation (e.g., mechanical valve replacement (bio-prostatic valve is permitted), high risk atrial fibrillation)
    2. Known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency
    3. Platelet count < 100 x 10^3 cells/mm3 or known platelet dysfunction
    4. INR > 1.4, elevated prothrombin time or activated partial thromboplastin time (aPTT), which cannot be corrected or otherwise accounted for (i.e., lupus anti-coagulant)
    5. Use of direct factor Xa inhibitors (e.g. apixaban, rivaroxaban, fondaparinux) within last 48 hours

  3. Patient Factors

    1. Traumatic ICH
    2. High risk atrial fibrillation (e.g., mitral stenosis with atrial fibrillation) and/or symptomatic carotid stenosis
    3. Requirement for emergent surgical decompression or uncontrolled ICP after EVD
    4. Unable to obtain consent per Institution Review Board/Ethics Committee policy
    5. Pregnancy or positive pregnancy test (either serum or urine). Women of child-bearing potential must have a negative pregnancy test prior to enrollment
    6. Severe active infection requiring treatment (e.g. sepsis or purulent wound) at the time of enrollment
    7. Renal failure indicated by creatinine > 2 mg/dL or undergoing dialysis
    8. Any comorbid disease or condition expected to compromise survival or ability to complete follow-up assessments through 365 days
    9. Based on investigator's judgement, patient is unwilling or unable to comply with protocol follow up appointment schedule
    10. Active drug or alcohol use or dependence that, in the opinion of the site investigator would interfere with adherence to study requirements
    11. Currently participating in another interventional (drug, device, etc) clinical trial. Patients in observational, natural history, and/or epidemiological studies not involving intervention are eligible.
Contacts and Locations
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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): NCT03342664


Contacts
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Contact: Rahsaan Holley +1 703-969-3634 rholley@penumbrainc.com
Contact: Brooke Lawson +1 510 995 2183 blawson@penumbrainc.com

Locations
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Sponsors and Collaborators
Penumbra Inc.
More Information
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Responsible Party: Penumbra Inc.
ClinicalTrials.gov Identifier: NCT03342664    
Other Study ID Numbers: 11899
First Posted: November 17, 2017    Key Record Dates
Last Update Posted: June 7, 2023
Last Verified: June 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Penumbra Inc.:
ICH
Stroke
Cerebral Hemorrhage
Intracranial Hemorrhage
 Hemorrhage
Cerebrovascular Disorders
Brain bleed
Additional relevant MeSH terms:
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Cerebral Hemorrhage
Intracranial Hemorrhages
Hemorrhage
Pathologic Processes
Cerebrovascular Disorders
 Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases