MIND: Artemis in the Removal of Intracerebral Hemorrhage

Completed · Not applicable

Conditions studied: Cerebral Hemorrhage, Brain Hemorrhage, Cerebral Parenchymal Hemorrhage, Intracerebral Hemorrhage

In brief

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).

Key facts

Study ID

NCT03342664

Run by

Penumbra Inc.

People needed

236

Starts

2018-02-06

Expected to finish

2024-09-23

Last updated by the study team

2026-01-30

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• Imaging
• "Arterial Spot Sign" identified on final CTA indicating expanding hemorrhage
• Hemorrhagic lesion such as a vascular malformation (cavernous malformation, AVM etc.), aneurysm, and/or neoplasm
• Hemorrhagic conversion of an underlying ischemic stroke
• Infratentorial hemorrhage
• Primary thalamic ICH (where the center of the hemorrhage emulates from the thalamus)
• Associated intra-ventricular hemorrhage requiring treatment for IVH-related mass effect or shift due to trapped ventricle (EVD for ICP management is allowed)
• Midbrain extension/involvement
• Absolute contraindication to CTA, conventional angiography and MRA
• Coagulation Issues
• Absolute requirement for long-term anti-coagulation (e.g., mechanical valve replacement (bio-prostatic valve is permitted), high risk atrial fibrillation)
• Known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency
• Platelet count < 100 x 10\^3 cells/mm3 or known platelet dysfunction
• 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)
• Use of direct factor Xa inhibitors (e.g. apixaban, rivaroxaban, fondaparinux) within last 48 hours
• Patient Factors
• Traumatic ICH
• High risk atrial fibrillation (e.g., mitral stenosis with atrial fibrillation) and/or symptomatic carotid stenosis
• Requirement for emergent surgical decompression or uncontrolled ICP after EVD
• Unable to obtain consent per Institution Review Board/Ethics Committee policy
• Pregnancy or positive pregnancy test (either serum or urine). Women of child-bearing potential must have a negative pregnancy test prior to enrollment
• Severe active infection requiring treatment (e.g. sepsis or purulent wound) at the time of enrollment
• Renal failure indicated by creatinine > 2 mg/dL or undergoing dialysis
• Any comorbid disease or condition expected to compromise survival or ability to complete follow-up assessments through 365 days
• Based on investigator's judgement, patient is unwilling or unable to comply with protocol follow up appointment schedule

Where it is running

• Abrazo Central — Phoenix, Arizona, United States
• UCLA — Los Angeles, California, United States
• Mission Hospital — Mission Viejo, California, United States
• Swedish - HCA — Englewood, Colorado, United States
• Yale University — New Haven, Connecticut, United States
• Christiana Health — Newark, Delaware, United States
• George Washington — Washington D.C., District of Columbia, United States
• Northwestern Memorial Hospital — Chicago, Illinois, United States
• Loyola University Chicago — Chicago, Illinois, United States
• University of Kentucky — Lexington, Kentucky, United States
• University of Louisville — Louisville, Kentucky, United States
• Ochsner Medical Center — New Orleans, Louisiana, United States
• University of Mississippi — Jackson, Mississippi, United States
• University of Missouri — Columbia, Missouri, United States
• Atlantic Neuroscience Institute — Summit, New Jersey, United States
• Maimonides — Brooklyn, New York, United States
• Northwell Health — Manhasset, New York, United States
• Mount Sinai — New York, New York, United States
• Stony Brook University — Stony Brook, New York, United States
• Novant Health — Charlotte, North Carolina, United States
• University Hospital Cleveland — Cleveland, Ohio, United States
• Geisinger Medical Center — Danville, Pennsylvania, United States
• MUSC — Charleston, South Carolina, United States
• Methodist University Hospital — Memphis, Tennessee, United States
• Valley Baptist Medical Center — Harlingen, Texas, United States

Full record on ClinicalTrials.gov

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