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Completed

NCT Number: NCT03342664

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).

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Uniklinikum Salzburg, Salzburg, Austria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • Active drug or alcohol use or dependence that, in the opinion of the site investigator would interfere with adherence to study requirements
  • Currently participating in another interventional (drug, device, etc) clinical trial. Patients in observational, natural history, and/or epidemiological studies not involving intervention are eligible.

Treatment and study plan

Artemis + Medical Management

Device

Subject will receive best MM in addition to the MIS procedure with Artemis.

Other names: MIS + MM

Best Medical Management Alone (MM)

Other

Subject will receive best MM for ICH as determined by stroke physician following AHA/ESO guidelines.

Other names: MM, Control

Primary outcomes

  1. Global Disability (Functional Outcome) Assessed Via the Ordinal Modified Rankin Score (mRS)

    Time frame: 180 days

    Modified Rankin scale measures degree of disability or functional impairment on a scale of 0 (no symptoms) to 5 (severe disability), 6 (expired), where higher scores mean a worse outcome

  2. Rate of Mortality

    Time frame: 30 days

Secondary outcomes

  1. Functional Outcomes Measured Via Utility Weighted Modified Rankin Score (mRS)

    Time frame: 180 days

    The utility-weighted modified Rankin Score (utility-weighted mRS) is a functional outcome measure that quantifies global disability. It is derived from the Ordinal Modified Rankin Scale (mRS), which assesses the degree of disability or functional impairment on a scale.

    The underlying Modified Rankin Scale categories range from 0 to 6, where:

    • 0 = No symptoms (best outcome)
    • 6 = Death (worst outcome)

    These categorical mRS values are converted to utility weights and the resulting the utility-weighted mRS produces a continuous score ranging from 0.00 to 1.00, where:

    • 0.00 represents the worst functional outcome (equivalent to severe disability or death)
    • 1.00 represents the best functional outcome (no symptoms and full independence)

    Higher scores indicate better functional outcomes. Lower scores indicate worse functional outcomes.

  2. Functional Outcomes Measured Via Modified Ordinal Rankin Score (mRS)

    Time frame: 365 days

    Modified Rankin scale measures degree of disability or functional impairment on a scale of 0 (no symptoms) to 5 (severe disability), 6 (expired), where higher scores mean a worse outcome

  3. Quality of Life Assessed Via Stroke Impact Scale

    Time frame: 180 and 365 days

    The Stroke Impact Scale measures mobility and activities of daily living by assessing ability to perform specific physical tasks using a 5-point scale that ranges from 1 (could not do it at all) to 5 (not difficult at all). The individual scores are converted to a scale of 0 (no recovery) -100 (full recovery) to represent level of recovery, where a higher score means better outcome.

  4. VAS Quality of Life Assessed Via EQ-5D-5L

    Time frame: 180 and 365 days

    The EQ-5D-5L (EuroQol 5 Dimension 5 Level) is a self assessment on activities of daily living using a visual analog scale (VAS) where current health is rated on a scale of 0 to 100 where 0 is the worst imaginable health and 100 is the best imaginable health.

  5. Length of Hospital Stay

    Time frame: Admission to hospital discharge (up to one year)

  6. Length of ICU

    Time frame: # of days from admission (up to one year)

  7. Length of Procedure

    Time frame: Time from initial sheath placement to final sheath removal

  8. Functional Outcomes Measured Via Modified Rankin Score (mRS) of ≤ 3

    Time frame: 180 days

    (0 no symptoms - 3 moderate disability)

  9. Functional Outcomes Measured Via Modified Rankin Score (mRS) of ≤ 2

    Time frame: 180 days

    mRS 0 no symptoms - 2 slight disability

Sponsors and collaborators

Lead sponsor

Penumbra Inc.

Industry

Registry information

Official study title

MIND: A Prospective, Multicenter Study of Artemis a Minimally Invasive Neuro Evacuation Device, in the Removal of Intracerebral Hemorrhage

Important dates

Study start
2018
Primary completion
2024
Study completion
2024
First posted
Nov 17, 2017
Registry last updated
Jan 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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