MIND: Artemis in the Removal of Intracerebral Hemorrhage

Last updated: February 7, 2024
Sponsor: Penumbra Inc.
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Hemorrhage

Stroke

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-related masseffect or shift due to trapped ventricle (EVD for ICP management is allowed)
  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 factor deficiency
  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 comply withprotocol 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 epidemiological studiesnot involving intervention are eligible.

Study Design

Total Participants: 500
Treatment Group(s): 2
Primary Treatment: Best Medical Management Alone (MM)
Phase:
Study Start date:
February 07, 2018
Estimated Completion Date:
November 30, 2024

Connect with a study center

  • Uniklinikum Salzburg

    Salzburg,
    Austria

    Site Not Available

  • University of Alberta

    Edmonton, Alberta
    Canada

    Site Not Available

  • Universitätsklinikum Augsburg

    Augsburg,
    Germany

    Site Not Available

  • Charité - Universitätsmedizin Berlin

    Berlin,
    Germany

    Site Not Available

  • Universitätsklinikum Freiburg

    Freiburg im Breisgau,
    Germany

    Site Not Available

  • München Klinik Bogenhausen

    München,
    Germany

    Site Not Available

  • Abrazo Central

    Phoenix, Arizona 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

  • Swedish - HCA

    Englewood, Colorado 80113
    United States

    Site Not Available

  • Yale University

    New Haven, Connecticut 06510
    United States

    Site Not Available

  • Christiana Health

    Newark, Delaware 19718
    United States

    Site Not Available

  • George Washington

    Washington, District of Columbia 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

  • University of Kentucky

    Lexington, Kentucky 40506
    United States

    Site Not Available

  • University of Louisville

    Louisville, Kentucky 40292
    United States

    Site Not Available

  • Ochsner Medical Center

    New Orleans, Louisiana 70121
    United States

    Site Not Available

  • University of Mississippi

    Jackson, Mississippi 39216
    United States

    Site Not Available

  • University of Missouri

    Columbia, Missouri 65211
    United States

    Site Not Available

  • Atlantic Neuroscience Institute

    Summit, New Jersey 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

  • Novant Health

    Charlotte, North Carolina 28277
    United States

    Site Not Available

  • University Hospital Cleveland

    Cleveland, Ohio 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

  • MUSC

    Charleston, South Carolina 29425
    United States

    Site Not Available

  • Methodist University Hospital

    Memphis, Tennessee 38120
    United States

    Site Not Available

  • Valley Baptist Medical Center

    Harlingen, Texas 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

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