MIND: Artemis in the Removal of Intracerebral Hemorrhage

Recruitment Status
COMPLETED - HAS RESULTS
(See Contacts and Locations)Verified December 2025 by Penumbra Inc.
Sponsor
Penumbra Inc.
Information Provided by (Responsible Party)
Penumbra Inc.
Clinicaltrials.gov Identifier
NCT03342664
Other Study ID Numbers:
11899
First Submitted
October 17, 2017
First Posted
November 16, 2017
Results First Posted
October 26, 2025
Last Update Posted
January 29, 2026
Last Verified
December 2025

ClinicalTrials.gov processed this data on January 2026. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

Condition or DiseaseIntervention/Treatment
Cerebral HemorrhageBrain HemorrhageCerebral Parenchymal HemorrhageIntracerebral Hemorrhage
Device: Artemis + Medical ManagementOther: Best Medical Management Alone (MM)

Study Design

Study TypeInterventional
Actual Enrollment236 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingSingle
Primary PurposeTreatment
Official TitleMIND: A Prospective, Multicenter Study of Artemis a Minimally Invasive Neuro Evacuation Device, in the Removal of Intracerebral Hemorrhage
Study Start DateFebruary 5, 2018
Actual Primary Completion DateFebruary 19, 2024
Actual Study Completion DateSeptember 22, 2024

Groups and Cohorts

Group/CohortIntervention/Treatment
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.
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.

Outcome Measures

Primary Outcome Measures
  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
  2. Rate of Mortality
Secondary Outcome Measures
  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.
  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
  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.
  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.
  5. Length of Hospital Stay
  6. Length of ICU
  7. Length of Procedure
  8. Functional Outcomes Measured Via Modified Rankin Score (mRS) of ≤ 3
    (0 no symptoms - 3 moderate disability)
  9. Functional Outcomes Measured Via Modified Rankin Score (mRS) of ≤ 2
    mRS 0 no symptoms - 2 slight disability

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
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.

Contacts and Locations

Sponsors and CollaboratorsPenumbra Inc.
Locations
Abrazo Central | Phoenix Arizona, United States, 85015UCLA | Los Angeles California, United States, 90095Mission Hospital | Mission Viejo California, United States, 92691Swedish - HCA | Englewood Colorado, United States, 80113Yale University | New Haven Connecticut, United States, 06510Christiana Health | Newark Delaware, United States, 19718George Washington | Washington D.C. District of Columbia, United States, 20052Northwestern Memorial Hospital | Chicago Illinois, United States, 60611Loyola University Chicago | Chicago Illinois, United States, 60660University of Kentucky | Lexington Kentucky, United States, 40506University of Louisville | Louisville Kentucky, United States, 40292Ochsner Medical Center | New Orleans Louisiana, United States, 70121University of Mississippi | Jackson Mississippi, United States, 39216University of Missouri | Columbia Missouri, United States, 65211Atlantic Neuroscience Institute | Summit New Jersey, United States, 07901Maimonides | Brooklyn New York, United States, 11219Northwell Health | Manhasset New York, United States, 11030Mount Sinai | New York New York, United States, 10029Stony Brook University | Stony Brook New York, United States, 11794Novant Health | Charlotte North Carolina, United States, 28277University Hospital Cleveland | Cleveland Ohio, United States, 44106Geisinger Medical Center | Danville Pennsylvania, United States, 17822MUSC | Charleston South Carolina, United States, 29425Methodist University Hospital | Memphis Tennessee, United States, 38120Valley Baptist Medical Center | Harlingen Texas, United States, 78520Virginia Mason Medical Center | Seattle Washington, United States, 98101Harborview Medical Center | Seattle Washington, United States, 98104Uniklinikum 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,
Study Documents (Full Text)
Documents provided by Penumbra Inc.: Study Protocol  January 13, 2020Documents provided by Penumbra Inc.: Statistical Analysis Plan  January 1, 2020