MIND: Artemis in the Removal of Intracerebral Hemorrhage

Last updated: January 29, 2026
Sponsor: Penumbra Inc.
Overall Status: Completed

Phase

N/A

Condition

Stroke

Hemorrhage

Brain Injury

Treatment

Best Medical Management Alone (MM)

Artemis + Medical Management

Clinical Study ID

NCT03342664
11899
  • Ages 18-80
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  1. Imaging

  2. "Arterial Spot Sign" identified on final CTA indicating expanding hemorrhage

  3. Hemorrhagic lesion such as a vascular malformation (cavernous malformation, AVMetc.), aneurysm, and/or neoplasm

  4. Hemorrhagic conversion of an underlying ischemic stroke

  5. Infratentorial hemorrhage

  6. Primary thalamic ICH (where the center of the hemorrhage emulates from thethalamus)

  7. Associated intra-ventricular hemorrhage requiring treatment for IVH-relatedmass effect or shift due to trapped ventricle (EVD for ICP management isallowed)

  8. Midbrain extension/involvement

  9. Absolute contraindication to CTA, conventional angiography and MRA

  10. Coagulation Issues

  11. Absolute requirement for long-term anti-coagulation (e.g., mechanical valvereplacement (bio-prostatic valve is permitted), high risk atrial fibrillation)

  12. Known hereditary or acquired hemorrhagic diathesis, coagulation factordeficiency

  13. Platelet count < 100 x 10^3 cells/mm3 or known platelet dysfunction

  14. INR > 1.4, elevated prothrombin time or activated partial thromboplastin time (aPTT), which cannot be corrected or otherwise accounted for (i.e., lupusanti-coagulant)

  15. Use of direct factor Xa inhibitors (e.g. apixaban, rivaroxaban, fondaparinux)within last 48 hours

  16. Patient Factors

  17. Traumatic ICH

  18. High risk atrial fibrillation (e.g., mitral stenosis with atrial fibrillation)and/or symptomatic carotid stenosis

  19. Requirement for emergent surgical decompression or uncontrolled ICP after EVD

  20. Unable to obtain consent per Institution Review Board/Ethics Committee policy

  21. Pregnancy or positive pregnancy test (either serum or urine). Women ofchild-bearing potential must have a negative pregnancy test prior to enrollment

  22. Severe active infection requiring treatment (e.g. sepsis or purulent wound) atthe time of enrollment

  23. Renal failure indicated by creatinine > 2 mg/dL or undergoing dialysis

  24. Any comorbid disease or condition expected to compromise survival or ability tocomplete follow-up assessments through 365 days

  25. Based on investigator's judgement, patient is unwilling or unable to complywith protocol follow up appointment schedule

  26. Active drug or alcohol use or dependence that, in the opinion of the siteinvestigator would interfere with adherence to study requirements

  27. Currently participating in another interventional (drug, device, etc) clinicaltrial. Patients in observational, natural history, and/or epidemiologicalstudies not involving intervention are eligible.

Study Design

Total Participants: 236
Treatment Group(s): 2
Primary Treatment: Best Medical Management Alone (MM)
Phase:
Study Start date:
February 06, 2018
Estimated Completion Date:
September 23, 2024

Connect with a study center

  • Uniklinikum Salzburg

    Salzburg,
    Austria

    Site Not Available

  • Uniklinikum Salzburg

    Salzburg 2766824,
    Austria

    Site Not Available

  • University of Alberta

    Edmonton, Alberta
    Canada

    Site Not Available

  • University of Alberta

    Edmonton 5946768, Alberta 5883102
    Canada

    Site Not Available

  • Universitätsklinikum Augsburg

    Augsburg,
    Germany

    Site Not Available

  • Universitätsklinikum Augsburg

    Augsburg 2954172,
    Germany

    Site Not Available

  • Charité - Universitätsmedizin Berlin

    Berlin,
    Germany

    Site Not Available

  • Charité - Universitätsmedizin Berlin

    Berlin 2950159,
    Germany

    Site Not Available

  • Universitätsklinikum Freiburg

    Freiburg im Breisgau,
    Germany

    Site Not Available

  • Universitätsklinikum Freiburg

    Freiburg im Breisgau 2925177,
    Germany

    Site Not Available

  • München Klinik Bogenhausen

    München,
    Germany

    Site Not Available

  • München Klinik Bogenhausen

    München 2867711,
    Germany

    Site Not Available

  • Abrazo Central

    Phoenix, Arizona 85015
    United States

    Site Not Available

  • Abrazo Central

    Phoenix 5308655, Arizona 5551752 85015
    United States

    Site Not Available

  • UCLA

    Los Angeles, California 90095
    United States

    Site Not Available

  • Mission Hospital

    Mission Viejo, California 92691
    United States

    Site Not Available

  • UCLA

    Los Angeles 5368361, California 5332921 90095
    United States

    Site Not Available

  • Mission Hospital

    Mission Viejo 5373763, California 5332921 92691
    United States

    Site Not Available

  • Swedish - HCA

    Englewood, Colorado 80113
    United States

    Site Not Available

  • Swedish - HCA

    Englewood 5421250, Colorado 5417618 80113
    United States

    Site Not Available

  • Yale University

    New Haven, Connecticut 06510
    United States

    Site Not Available

  • Yale University

    New Haven 4839366, Connecticut 4831725 06510
    United States

    Site Not Available

  • Christiana Health

    Newark, Delaware 19718
    United States

    Site Not Available

  • Christiana Health

    Newark 4143861, Delaware 4142224 19718
    United States

    Site Not Available

  • George Washington

    Washington, District of Columbia 20052
    United States

    Site Not Available

  • George Washington

    Washington D.C. 4140963, District of Columbia 4138106 20052
    United States

    Site Not Available

  • Loyola University Chicago

    Chicago, Illinois 60660
    United States

    Site Not Available

  • Northwestern Memorial Hospital

    Chicago, Illinois 60611
    United States

    Site Not Available

  • Loyola University Chicago

    Chicago 4887398, Illinois 4896861 60660
    United States

    Site Not Available

  • Northwestern Memorial Hospital

    Chicago 4887398, Illinois 4896861 60611
    United States

    Site Not Available

  • University of Kentucky

    Lexington, Kentucky 40506
    United States

    Site Not Available

  • University of Louisville

    Louisville, Kentucky 40292
    United States

    Site Not Available

  • University of Kentucky

    Lexington 4297983, Kentucky 6254925 40506
    United States

    Site Not Available

  • University of Louisville

    Louisville 4299276, Kentucky 6254925 40292
    United States

    Site Not Available

  • Ochsner Medical Center

    New Orleans, Louisiana 70121
    United States

    Site Not Available

  • Ochsner Medical Center

    New Orleans 4335045, Louisiana 4331987 70121
    United States

    Site Not Available

  • University of Mississippi

    Jackson, Mississippi 39216
    United States

    Site Not Available

  • University of Mississippi

    Jackson 4431410, Mississippi 4436296 39216
    United States

    Site Not Available

  • University of Missouri

    Columbia, Missouri 65211
    United States

    Site Not Available

  • University of Missouri

    Columbia 4381982, Missouri 4398678 65211
    United States

    Site Not Available

  • Atlantic Neuroscience Institute

    Summit, New Jersey 07901
    United States

    Site Not Available

  • Atlantic Neuroscience Institute

    Summit 5105127, New Jersey 5101760 07901
    United States

    Site Not Available

  • Maimonides

    Brooklyn, New York 11219
    United States

    Site Not Available

  • Northwell Health

    Manhasset, New York 11030
    United States

    Site Not Available

  • Mount Sinai

    New York, New York 10029
    United States

    Site Not Available

  • Stony Brook University

    Stony Brook, New York 11794
    United States

    Site Not Available

  • Maimonides

    Brooklyn 5110302, New York 5128638 11219
    United States

    Site Not Available

  • Northwell Health

    Manhasset 5125766, New York 5128638 11030
    United States

    Site Not Available

  • Mount Sinai

    New York 5128581, New York 5128638 10029
    United States

    Site Not Available

  • Stony Brook University

    Stony Brook 5139865, New York 5128638 11794
    United States

    Site Not Available

  • Novant Health

    Charlotte, North Carolina 28277
    United States

    Site Not Available

  • Novant Health

    Charlotte 4460243, North Carolina 4482348 28277
    United States

    Site Not Available

  • University Hospital Cleveland

    Cleveland, Ohio 44106
    United States

    Site Not Available

  • University Hospital Cleveland

    Cleveland 5150529, Ohio 5165418 44106
    United States

    Site Not Available

  • OUHSC

    Oklahoma City, Oklahoma 73104
    United States

    Site Not Available

  • Geisinger Medical Center

    Danville, Pennsylvania 17822
    United States

    Site Not Available

  • Geisinger Medical Center

    Danville 5186327, Pennsylvania 6254927 17822
    United States

    Site Not Available

  • MUSC

    Charleston, South Carolina 29425
    United States

    Site Not Available

  • MUSC

    Charleston 4574324, South Carolina 4597040 29425
    United States

    Site Not Available

  • Methodist University Hospital

    Memphis, Tennessee 38120
    United States

    Site Not Available

  • Methodist University Hospital

    Memphis 4641239, Tennessee 4662168 38120
    United States

    Site Not Available

  • Valley Baptist Medical Center

    Harlingen, Texas 78520
    United States

    Site Not Available

  • Valley Baptist Medical Center

    Harlingen 4696233, Texas 4736286 78520
    United States

    Site Not Available

  • Harborview Medical Center

    Seattle, Washington 98104
    United States

    Site Not Available

  • Virginia Mason Medical Center

    Seattle, Washington 98101
    United States

    Site Not Available

  • Harborview Medical Center

    Seattle 5809844, Washington 5815135 98104
    United States

    Site Not Available

  • Virginia Mason Medical Center

    Seattle 5809844, Washington 5815135 98101
    United States

    Site Not Available

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