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Purpose

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

Eligibility

Eligible Ages
Between 18 Years and 80 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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 Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention 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).
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)
Masking Description
180 day mRS is blinded

Arm Groups

ArmDescriptionAssigned Intervention
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:
    • MM
    • Control

Recruiting Locations

More Details

NCT ID
NCT03342664
Status
Active, not recruiting
Sponsor
Penumbra Inc.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.