Skip to Main Content

MIND: Artemis in the Removal of Intracerebral Hemorrhage

  • Study HIC#:2000025394
  • Last Updated:07/15/2021

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).

  • Age18 years - 80 years
  • GenderBoth
  • Start Date12/04/2019
  • End Date02/28/2021

Trial Purpose and Description

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).

Eligibility 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 (hemorrhage increase of < 5 cc as confirmed by 2 CT/MR taken a minimum of 6 hours apart)
  4. NIHSS ≥ 6
  5. Presenting GCS ≥ 5 and ≤ 15
  6. Historical mRS 0 or 1
  7. Symptom onset < 24 hours prior to initial CT
  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. Expanding hemorrhage on final screening CT/MR scan
    2. "Arterial Spot sign" identified on CTA (may perform additional CTA(s) every 6 hours to demonstrate resolution)
    3. Hemorrhagic lesion such as a vascular malformation (cavernous malformation, AVM etc.), aneurysm, and/or neoplasm
    4. Hemorrhagic conversion of an underlying ischemic stroke
    5. Infratentorial hemorrhage
    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)
  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 from patient or legally authorized representative (LAR; for patients without competence)
    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. Evidence of active infection indicated by fever ≥ 100.7 °F/ 38.2°C and/or open draining wound at the time of randomization
    7. Any comorbid disease or condition expected to compromise survival or ability to complete follow-up assessments through 365 days
    8. Based on investigator's judgement, patient is unwilling or unable to comply with protocol follow up appointment schedule
    9. Active drug or alcohol use or dependence that, in the opinion of the site investigator would interfere with adherence to study requirements
    10. Currently participating in another interventional (drug, device, etc) clinical trial. Patients in observational, natural history, and/or epidemiological studies not involving intervention are eligible.

Principal Investigator

Sub-Investigator

For more information about this study, contact the Help us Discover team on: