MIND: Artemis in the Removal of Intracerebral Hemorrhage

NCT ID: NCT03342664

Last Updated: 2026-01-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 236 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-06
• Study Completion Date: 2024-09-23

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).

Conditions

Cerebral Hemorrhage; Brain Hemorrhage; Cerebral Parenchymal Hemorrhage; Intracerebral Hemorrhage

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Artemis + Medical Management (MIS)

Minimally invasive hematoma evacuation with the Artemis Neuro Evacuation Device with medical management

Group Type: EXPERIMENTAL

Artemis + Medical Management

Intervention Type: DEVICE

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

Group Type: ACTIVE_COMPARATOR

Best Medical Management Alone (MM)

Intervention Type: OTHER

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

Interventions

Artemis + Medical Management

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

Intervention Type: DEVICE

Best Medical Management Alone (MM)

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

Intervention Type: OTHER

Other Intervention Names

MIS + MM; MM; Control

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Penumbra Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Abrazo Central

Phoenix, Arizona, United States

UCLA

Los Angeles, California, United States

Mission Hospital

Mission Viejo, California, United States

Swedish - HCA

Englewood, Colorado, United States

Yale University

New Haven, Connecticut, United States

Christiana Health

Newark, Delaware, United States

George Washington

Washington D.C., District of Columbia, United States

Northwestern Memorial Hospital

Chicago, Illinois, United States

Loyola University Chicago

Chicago, Illinois, United States

University of Kentucky

Lexington, Kentucky, United States

University of Louisville

Louisville, Kentucky, United States

Ochsner Medical Center

New Orleans, Louisiana, United States

University of Mississippi

Jackson, Mississippi, United States

University of Missouri

Columbia, Missouri, United States

Atlantic Neuroscience Institute

Summit, New Jersey, United States

Maimonides

Brooklyn, New York, United States

Northwell Health

Manhasset, New York, United States

Mount Sinai

New York, New York, United States

Stony Brook University

Stony Brook, New York, United States

Novant Health

Charlotte, North Carolina, United States

University Hospital Cleveland

Cleveland, Ohio, United States

Geisinger Medical Center

Danville, Pennsylvania, United States

MUSC

Charleston, South Carolina, United States

Methodist University Hospital

Memphis, Tennessee, United States

Valley Baptist Medical Center

Harlingen, Texas, United States

Virginia Mason Medical Center

Seattle, Washington, United States

Harborview Medical Center

Seattle, Washington, 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

Countries

United States; Austria; Canada; Germany

References

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.

Reference Type: DERIVED

PMID: 40892424 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

11899

Identifier Type: -

Identifier Source: org_study_id