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Cerebral HemorrhageNCT03342664

MIND: Artemis in the Removal of Intracerebral Hemorrhage

A study testing Artemis + Medical Management and Best Medical Management Alone (MM) in people with Cerebral Hemorrhage and Brain Hemorrhage, run by Penumbra Inc. at 33 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Artemis + Medical Management and Best Medical Management Alone (MM)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
236 participants
Where
33 sitesin 4 countries
Study dates
6 Feb 2018to 23 Sep 2024
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 9Show fewer
  • 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

Who cannot join

  • 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)
Show all 27Show fewer
  • 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.

Trial locations and contacts

33 sites in 4 countries.

33 sites in 4 countries

United States27 sites

  • Maimonides

    Brooklyn, New York, 11219

  • MUSC

    Charleston, South Carolina, 29425

  • Novant Health

    Charlotte, North Carolina, 28277

  • Northwestern Memorial Hospital

    Chicago, Illinois, 60611

  • Loyola University Chicago

    Chicago, Illinois, 60660

  • University Hospital Cleveland

    Cleveland, Ohio, 44106

  • University of Missouri

    Columbia, Missouri, 65211

  • Geisinger Medical Center

    Danville, Pennsylvania, 17822

  • Swedish - HCA

    Englewood, Colorado, 80113

  • Valley Baptist Medical Center

    Harlingen, Texas, 78520

  • University of Mississippi

    Jackson, Mississippi, 39216

  • University of Kentucky

    Lexington, Kentucky, 40506

  • UCLA

    Los Angeles, California, 90095

  • University of Louisville

    Louisville, Kentucky, 40292

  • Northwell Health

    Manhasset, New York, 11030

  • Methodist University Hospital

    Memphis, Tennessee, 38120

  • Mission Hospital

    Mission Viejo, California, 92691

  • Yale University

    New Haven, Connecticut, 06510

  • Ochsner Medical Center

    New Orleans, Louisiana, 70121

  • Mount Sinai

    New York, New York, 10029

  • Christiana Health

    Newark, Delaware, 19718

  • Abrazo Central

    Phoenix, Arizona, 85015

  • Virginia Mason Medical Center

    Seattle, Washington, 98101

  • Harborview Medical Center

    Seattle, Washington, 98104

  • Stony Brook University

    Stony Brook, New York, 11794

  • Atlantic Neuroscience Institute

    Summit, New Jersey, 07901

  • George Washington

    Washington D.C., District of Columbia, 20052

Other trials in United States

Germany4 sites

  • Universitätsklinikum Augsburg

    Augsburg

  • Charité - Universitätsmedizin Berlin

    Berlin

  • Universitätsklinikum Freiburg

    Freiburg im Breisgau

  • München Klinik Bogenhausen

    München

Other trials in Germany

Austria1 site

  • Uniklinikum Salzburg

    Salzburg

Other trials in Austria

Canada1 site

  • University of Alberta

    Edmonton, Alberta

Other trials in Canada

About this study

Official title: MIND: A Prospective, Multicenter Study of Artemis a Minimally Invasive Neuro Evacuation Device, 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).

Being tested
Artemis + Medical Management, Best Medical Management Alone (MM)
Keywords
ICH, Stroke, Cerebral Hemorrhage, Intracranial Hemorrhage, Hemorrhage, Cerebrovascular Disorders, Brain bleed
Medical subject headings
Cerebral Hemorrhage, Intracranial Hemorrhages, Stroke, Hemorrhage, Cerebrovascular Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Artemis + Medical ManagementDevice

    Also called MIS + MM

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

  • Best Medical Management Alone (MM)Other

    Also called MM, Control

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

Study groups in NCT03342664
Study groupRoleWhat they receive
Artemis + Medical Management (MIS)ExperimentalMinimally invasive hematoma evacuation with the Artemis Neuro Evacuation Device with medical management
Receives: Device: Artemis + Medical Management
Best Medical Management Alone (MM)Active comparatorBest medical management alone per standard of care at treating institution
Receives: Other: Best Medical Management Alone (MM)

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    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

    Measured: 180 days

  2. Rate of Mortality

    Measured: 30 days

Secondary outcomes (9)

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

    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.

    Measured: 180 days

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

    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

    Measured: 365 days

  3. Quality of Life Assessed Via Stroke Impact Scale

    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.

    Measured: 180 and 365 days

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

    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.

    Measured: 180 and 365 days

  5. Length of Hospital Stay

    Measured: Admission to hospital discharge (up to one year)

  6. Length of ICU

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

  7. Length of Procedure

    Measured: Time from initial sheath placement to final sheath removal

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

    (0 no symptoms - 3 moderate disability)

    Measured: 180 days

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

    mRS 0 no symptoms - 2 slight disability

    Measured: 180 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Nov 2017
  2. Study start6 Feb 2018
  3. Primary completion20 Feb 2024
  4. Study completion23 Sep 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Subjects will be randomized to either minimally invasive hematoma evacuation with the Artemis Neuro Evacuation Device with medical management (MIS group) or best medical management alone (2:1) (MM).
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
236 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03342664
Sponsor's protocol ID
11899
Status last verified
Jan 2026
First submitted
18 Oct 2017
Last updated
30 Jan 2026
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes

Publications

  • Arthur AS, Jahromi BS, Saphier PS, Nickele CM, Ryan RW, Vajkoczy P, Schirmer CM, Kellner CP, Matouk CC, Arias EJ, Ullman JS, Levitt MR, Hage ZA, Fiorella DJ; MIND Study Investigators and Collaborators. Minimally Invasive Surgery vs Medical Management Alone for Intracerebral Hemorrhage: The MIND Randomized Clinical Trial. JAMA Neurol. 2025 Nov 1;82(11):1113-1121. doi: 10.1001/jamaneurol.2025.3151.

    PubMed 40892424

  • Shiomi Y, Miwa K, Jensen M, Inoue M, Yoshimura S, Kamogawa N, Fukuda-Doi M, Ma H, Ringleb P, Wu O, Schwamm LH, Davis SM, Donnan GA, Gerloff C, Nakahara J, Toyoda K, Thomalla G, Koga M. Efficacy and safety of intravenous alteplase for unknown onset stroke on prior antiplatelet therapy: Post hoc analysis of the EOS individual participant data. Int J Stroke. 2025 Jul;20(6):679-686. doi: 10.1177/17474930251322034. Epub 2025 Feb 27.

    PubMed 39921231

Questions about this trial

What is this clinical trial studying?

A study testing Artemis + Medical Management and Best Medical Management Alone (MM) in people with Cerebral Hemorrhage and Brain Hemorrhage, run by Penumbra Inc. at 33 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 33 sites in United States, Germany, Austria, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Global Disability (Functional Outcome) Assessed Via the Ordinal Modified Rankin Score (mRS) (time frame: 180 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03342664, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2026.

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