MIND: Artemis in the Removal of Intracerebral Hemorrhage

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: Completed
• Conditions: Cerebral Hemorrhage; Intracerebral Hemorrhage; Brain Hemorrhage; Cerebral Parenchymal Hemorrhage
• Intervention / Treatment: Device: Artemis + Medical Management; Other: Best Medical Management Alone (MM)

• Study Type: Interventional
• Enrollment (Actual): 236
• Phase: Not Applicable

Contacts and Locations

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
    • Universitatsklinikum 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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Rate of Mortality		30 days
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	180 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of ICU		# of days from admission (up to one year)
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.	180 days
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	365 days
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.	180 and 365 days
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.	180 and 365 days
Length of Hospital Stay		Admission to hospital discharge (up to one year)
Length of Procedure		Time from initial sheath placement to final sheath removal
Functional Outcomes Measured Via Modified Rankin Score (mRS) of ≤ 3	(0 no symptoms - 3 moderate disability)	180 days
Functional Outcomes Measured Via Modified Rankin Score (mRS) of ≤ 2	mRS 0 no symptoms - 2 slight disability	180 days

Collaborators and Investigators

• Sponsor: Penumbra Inc.

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 6, 2018
• Primary Completion (Actual): February 20, 2024
• Study Completion (Actual): September 23, 2024

Study Registration Dates

• First Submitted: October 18, 2017
• First Submitted That Met QC Criteria: November 13, 2017
• First Posted (Actual): November 17, 2017

Study Record Updates

• Last Update Posted (Actual): January 30, 2026
• Last Update Submitted That Met QC Criteria: January 29, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Stroke; ICH; Cerebral Hemorrhage; Hemorrhage; Cerebrovascular Disorders; Intracranial Hemorrhage; Brain bleed
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Stroke; Cerebrovascular Disorders; Hemorrhage; Cerebral Hemorrhage; Intracranial Hemorrhages
• Other Study ID 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