MIND: Artemis in the Removal of Intracerebral Hemorrhage
MIND: Artemis in the Removal of Intracerebral Hemorrhage
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).
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.