MIND: Artemis in the Removal of Intracerebral Hemorrhage

Study Overview
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Brief Summary
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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).

Official Title
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MIND: A Prospective, Multicenter Study of Artemis a Minimally Invasive Neuro Evacuation Device, in the Removal of Intracerebral Hemorrhage

Conditions
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Cerebral Hemorrhage, Brain Hemorrhage, Cerebral Parenchymal Hemorrhage, Intracerebral Hemorrhage

Intervention / Treatment
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* Device: Artemis + Medical Management
* Other: Best Medical Management Alone (MM)


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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Subjects will be randomized to either minimally invasive hematoma evacuation with the Artemis Neuro Evacuation Device with medical management (MIS group) or best medical management alone (2:1) (MM).
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Artemis + Medical Management (MIS)<br>Minimally invasive hematoma evacuation with the Artemis Neuro Evacuation Device with medical management | Device: Artemis + Medical Management<br>* Subject will receive best MM in addition to the MIS procedure with Artemis.<br>* Other names: MIS + MM;|
| Active Comparator: Best Medical Management Alone (MM)<br>Best medical management alone per standard of care at treating institution | Other: Best Medical Management Alone (MM)<br>* Subject will receive best MM for ICH as determined by stroke physician following AHA/ESO guidelines.<br>* Other names: Control;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global disability (functional outcome) assessed via the ordinal modified Rankin score (mRS) | (0 no symptoms - 5 severe disability) | 180 days | 
| Rate of mortality |  | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional outcomes measured via weighted modified Rankin Score (mRS) | (0 no symptoms - 5 severe disability) | 180 days | 
| Functional outcomes measured via modified Rankin Score (mRS) | (0 no symptoms - 5 severe disability) | 365 days | 
| Quality of life assessed via Stroke Impact Scale | Measures mobility and activities of daily living | 180 and 365 days | 
| Quality of life assessed via EQ-5D-5L | Self assessment on activities of daily living | 180 and 365 days | 
| Length of hospital stay |  | Admission to hospital discharge (up to one year) | 
| Length of ICU |  | # of days from admission (up to one year) | 
| Length of procedure |  | Time in minutes at the time of surgery (up to one day) | 
| Functional outcomes measured via modified Rankin Score (mRS) of ≤ 3 | (0 no symptoms - 5 severe disability) | 180 days | 
| Functional outcomes measured via modified Rankin Score (mRS) of ≤ 2 | (0 no symptoms - 5 severe disability) | 180 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Brain bleed, ICH, Stroke, Cerebral Hemorrhage, Intracranial Hemorrhage, Hemorrhage, Cerebrovascular Disorders