MIND: Artemis in the Removal of Intracerebral Hemorrhage

January 29, 2026 updated by: Penumbra Inc.

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
236

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Austria
      • Salzburg, Austria
        • Uniklinikum Salzburg
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada
        • University of Alberta
  • Germany
      • Augsburg, Germany
        • Universitätsklinikum Augsburg
      • Berlin, Germany
        • Charité - Universitätsmedizin Berlin
      • Freiburg im Breisgau, Germany
        • Universitätsklinikum Freiburg
      • München, Germany
        • Munchen Klinik Bogenhausen
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85015
        • Abrazo Central
    • California
      • Los Angeles, California, United States, 90095
        • UCLA
      • Mission Viejo, California, United States, 92691
        • Mission Hospital
    • Colorado
      • Englewood, Colorado, United States, 80113
        • Swedish - HCA
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Yale University
    • Delaware
      • Newark, Delaware, United States, 19718
        • Christiana Health
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20052
        • George Washington
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern Memorial Hospital
      • Chicago, Illinois, United States, 60660
        • Loyola University Chicago
    • Kentucky
      • Lexington, Kentucky, United States, 40506
        • University Of Kentucky
      • Louisville, Kentucky, United States, 40292
        • University Of Louisville
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • Ochsner Medical Center
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • University of Mississippi
    • Missouri
      • Columbia, Missouri, United States, 65211
        • University of Missouri
    • New Jersey
      • Summit, New Jersey, United States, 07901
        • Atlantic Neuroscience Institute
    • New York
      • Brooklyn, New York, United States, 11219
        • Maimonides
      • Manhasset, New York, United States, 11030
        • Northwell Health
      • New York, New York, United States, 10029
        • Mount Sinai
      • Stony Brook, New York, United States, 11794
        • Stony Brook University
    • North Carolina
      • Charlotte, North Carolina, United States, 28277
        • Novant Health
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • University Hospital Cleveland
    • Pennsylvania
      • Danville, Pennsylvania, United States, 17822
        • Geisinger Medical Center
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • MUSC
    • Tennessee
      • Memphis, Tennessee, United States, 38120
        • Methodist University Hospital
    • Texas
      • Harlingen, Texas, United States, 78520
        • Valley Baptist Medical Center
    • Washington
      • Seattle, Washington, United States, 98104
        • Harborview Medical Center
      • Seattle, Washington, United States, 98101
        • Virginia Mason Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Criteria:

  1. Imaging

    1. "Arterial Spot Sign" identified on final CTA indicating expanding hemorrhage
    2. Hemorrhagic lesion such as a vascular malformation (cavernous malformation, AVM etc.), aneurysm, and/or neoplasm
    3. Hemorrhagic conversion of an underlying ischemic stroke
    4. Infratentorial hemorrhage
    5. Primary thalamic ICH (where the center of the hemorrhage emulates from the thalamus)
    6. Associated intra-ventricular hemorrhage requiring treatment for IVH-related mass effect or shift due to trapped ventricle (EVD for ICP management is allowed)
    7. Midbrain extension/involvement
    8. Absolute contraindication to CTA, conventional angiography and MRA

  2. Coagulation Issues

    1. Absolute requirement for long-term anti-coagulation (e.g., mechanical valve replacement (bio-prostatic valve is permitted), high risk atrial fibrillation)
    2. Known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency
    3. Platelet count < 100 x 10^3 cells/mm3 or known platelet dysfunction
    4. 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)
    5. Use of direct factor Xa inhibitors (e.g. apixaban, rivaroxaban, fondaparinux) within last 48 hours

  3. Patient Factors

    1. Traumatic ICH
    2. High risk atrial fibrillation (e.g., mitral stenosis with atrial fibrillation) and/or symptomatic carotid stenosis
    3. Requirement for emergent surgical decompression or uncontrolled ICP after EVD
    4. Unable to obtain consent per Institution Review Board/Ethics Committee policy
    5. Pregnancy or positive pregnancy test (either serum or urine). Women of child-bearing potential must have a negative pregnancy test prior to enrollment
    6. Severe active infection requiring treatment (e.g. sepsis or purulent wound) at the time of enrollment
    7. Renal failure indicated by creatinine > 2 mg/dL or undergoing dialysis
    8. Any comorbid disease or condition expected to compromise survival or ability to complete follow-up assessments through 365 days
    9. Based on investigator's judgement, patient is unwilling or unable to comply with protocol follow up appointment schedule
    10. Active drug or alcohol use or dependence that, in the opinion of the site investigator would interfere with adherence to study requirements
    11. Currently participating in another interventional (drug, device, etc) clinical trial. Patients in observational, natural history, and/or epidemiological studies not involving intervention are eligible.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Artemis + Medical Management (MIS)
Minimally invasive hematoma evacuation with the Artemis Neuro Evacuation Device with medical management
Device: Artemis + Medical Management
Subject will receive best MM in addition to the MIS procedure with Artemis.
Other Names:
  • MIS + MM
Active Comparator: Best Medical Management Alone (MM)
Best medical management alone per standard of care at treating institution
Other: Best Medical Management Alone (MM)
Subject will receive best MM for ICH as determined by stroke physician following AHA/ESO guidelines.
Other Names:
  • Control
  • MM

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Rate of Mortality
Time Frame: 30 days
30 days
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
180 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Length of ICU
Time Frame: # of days from admission (up to one year)
# of days from admission (up to one year)
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.
180 days
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
365 days
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.
180 and 365 days
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.
180 and 365 days
Length of Hospital Stay
Time Frame: Admission to hospital discharge (up to one year)
Admission to hospital discharge (up to one year)
Length of Procedure
Time Frame: Time from initial sheath placement to final sheath removal
Time from initial sheath placement to final sheath removal
Functional Outcomes Measured Via Modified Rankin Score (mRS) of ≤ 3
Time Frame: 180 days
(0 no symptoms - 3 moderate disability)
180 days
Functional Outcomes Measured Via Modified Rankin Score (mRS) of ≤ 2
Time Frame: 180 days
mRS 0 no symptoms - 2 slight disability
180 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Penumbra Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 6, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 20, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 23, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 18, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 13, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 17, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 30, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 29, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 11899

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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