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
1 other identifier
interventional
236
4 countries
33
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2018
Longer than P75 for not_applicable
33 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 18, 2017
CompletedFirst Posted
Study publicly available on registry
November 17, 2017
CompletedStudy Start
First participant enrolled
February 6, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 20, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
September 23, 2024
CompletedResults Posted
Study results publicly available
January 30, 2026
CompletedJanuary 30, 2026
January 1, 2026
6 years
October 18, 2017
October 27, 2025
January 29, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
Rate of Mortality
30 days
Secondary Outcomes (9)
Functional Outcomes Measured Via Utility Weighted Modified Rankin Score (mRS)
180 days
Functional Outcomes Measured Via Modified Ordinal Rankin Score (mRS)
365 days
Quality of Life Assessed Via Stroke Impact Scale
180 and 365 days
VAS Quality of Life Assessed Via EQ-5D-5L
180 and 365 days
Length of Hospital Stay
Admission to hospital discharge (up to one year)
- +4 more secondary outcomes
Study Arms (2)
Artemis + Medical Management (MIS)
EXPERIMENTALMinimally invasive hematoma evacuation with the Artemis Neuro Evacuation Device with medical management
Best Medical Management Alone (MM)
ACTIVE COMPARATORBest medical management alone per standard of care at treating institution
Interventions
Subject will receive best MM in addition to the MIS procedure with Artemis.
Subject will receive best MM for ICH as determined by stroke physician following AHA/ESO guidelines.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +12 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Penumbra Inc.lead
Study Sites (33)
Abrazo Central
Phoenix, Arizona, 85015, United States
UCLA
Los Angeles, California, 90095, United States
Mission Hospital
Mission Viejo, California, 92691, United States
Swedish - HCA
Englewood, Colorado, 80113, United States
Yale University
New Haven, Connecticut, 06510, United States
Christiana Health
Newark, Delaware, 19718, United States
George Washington
Washington D.C., District of Columbia, 20052, United States
Northwestern Memorial Hospital
Chicago, Illinois, 60611, United States
Loyola University Chicago
Chicago, Illinois, 60660, United States
University of Kentucky
Lexington, Kentucky, 40506, United States
University of Louisville
Louisville, Kentucky, 40292, United States
Ochsner Medical Center
New Orleans, Louisiana, 70121, United States
University of Mississippi
Jackson, Mississippi, 39216, United States
University of Missouri
Columbia, Missouri, 65211, United States
Atlantic Neuroscience Institute
Summit, New Jersey, 07901, United States
Maimonides
Brooklyn, New York, 11219, United States
Northwell Health
Manhasset, New York, 11030, United States
Mount Sinai
New York, New York, 10029, United States
Stony Brook University
Stony Brook, New York, 11794, United States
Novant Health
Charlotte, North Carolina, 28277, United States
University Hospital Cleveland
Cleveland, Ohio, 44106, United States
Geisinger Medical Center
Danville, Pennsylvania, 17822, United States
MUSC
Charleston, South Carolina, 29425, United States
Methodist University Hospital
Memphis, Tennessee, 38120, United States
Valley Baptist Medical Center
Harlingen, Texas, 78520, United States
Virginia Mason Medical Center
Seattle, Washington, 98101, United States
Harborview Medical Center
Seattle, Washington, 98104, United States
Uniklinikum Salzburg
Salzburg, Austria
University of Alberta
Edmonton, Alberta, Canada
Universitätsklinikum Augsburg
Augsburg, Germany
Charité - Universitätsmedizin Berlin
Berlin, Germany
Universitätsklinikum Freiburg
Freiburg im Breisgau, Germany
München Klinik Bogenhausen
München, Germany
Related Publications (1)
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.
PMID: 40892424DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Brooke Lawson, Sr. Director, Clinical Research- Neuro
- Organization
- Penumbra, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- 180 day mRS is blinded
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 18, 2017
First Posted
November 17, 2017
Study Start
February 6, 2018
Primary Completion
February 20, 2024
Study Completion
September 23, 2024
Last Updated
January 30, 2026
Results First Posted
January 30, 2026
Record last verified: 2026-01