Clinical trial NCT03342664: MIND: Artemis in the Removal of Intracerebral Hemorrhage
Official title: MIND: A Prospective, Multicenter Study of Artemis a Minimally Invasive Neuro Evacuation Device, in the Removal of Intracerebral Hemorrhage
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cerebral Hemorrhage
Brain Hemorrhage
Cerebral Parenchymal Hemorrhage
Intracerebral Hemorrhage
Keywords: ICH
Stroke
Cerebral Hemorrhage
Intracranial Hemorrhage
Hemorrhage
Cerebrovascular Disorders
Brain bleed
Lead sponsor: Penumbra Inc.
Sponsor class: INDUSTRY
First posted: 2017-11-17
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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

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).


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.

Primary outcomes:
measure: Global disability (functional outcome) assessed via the ordinal modified Rankin score (mRS)
timeFrame: 180 days
measure: Rate of mortality
timeFrame: 30 days
Secondary outcomes:
measure: Functional outcomes measured via weighted modified Rankin Score (mRS)
timeFrame: 180 days
measure: Functional outcomes measured via modified Rankin Score (mRS)
timeFrame: 365 days
measure: Quality of life assessed via Stroke Impact Scale
timeFrame: 180 and 365 days
measure: Quality of life assessed via EQ-5D-5L
timeFrame: 180 and 365 days
measure: Length of hospital stay
timeFrame: Admission to hospital discharge (up to one year)
measure: Length of ICU
timeFrame: # of days from admission (up to one year)
measure: Length of procedure
timeFrame: Time in minutes at the time of surgery (up to one day)
measure: Functional outcomes measured via modified Rankin Score (mRS) of ≤ 3
timeFrame: 180 days
measure: Functional outcomes measured via modified Rankin Score (mRS) of ≤ 2
timeFrame: 180 days
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Abrazo Central
state: Arizona
city: Los Angeles
country: United States
facility: UCLA
state: California
city: Mission Viejo
country: United States
facility: Mission Hospital
state: California
city: Englewood
country: United States
facility: Swedish - HCA
state: Colorado
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: Newark
country: United States
facility: Christiana Health
state: Delaware
city: Washington
country: United States
facility: George Washington
state: District of Columbia
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
city: Chicago
country: United States
facility: Loyola University Chicago
state: Illinois
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
city: New Orleans
country: United States
facility: Ochsner Medical Center
state: Louisiana
city: Jackson
country: United States
facility: University of Mississippi
state: Mississippi
city: Columbia
country: United States
facility: University of Missouri
state: Missouri
city: Summit
country: United States
facility: Atlantic Neuroscience Institute
state: New Jersey
city: Brooklyn
country: United States
facility: Maimonides
state: New York
city: Manhasset
country: United States
facility: Northwell Health
state: New York
city: New York
country: United States
facility: Mount Sinai
state: New York
city: Stony Brook
country: United States
facility: Stony Brook University
state: New York
city: Charlotte
country: United States
facility: Novant Health
state: North Carolina
city: Cleveland
country: United States
facility: University Hospital Cleveland
state: Ohio
city: Danville
country: United States
facility: Geisinger Medical Center
state: Pennsylvania
city: Charleston
country: United States
facility: MUSC
state: South Carolina
city: Memphis
country: United States
facility: Methodist University Hospital
state: Tennessee
city: Harlingen
country: United States
facility: Valley Baptist Medical Center
state: Texas
city: Seattle
country: United States
facility: Virginia Mason Medical Center
state: Washington
city: Seattle
country: United States
facility: Harborview Medical Center
state: Washington
city: Salzburg
country: Austria
facility: Uniklinikum Salzburg
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
city: Augsburg
country: Germany
facility: Universitätsklinikum Augsburg
city: Berlin
country: Germany
facility: Charité - Universitätsmedizin Berlin
city: Freiburg im Breisgau
country: Germany
facility: Universitätsklinikum Freiburg
city: München
country: Germany
facility: München Klinik Bogenhausen
Study officials:
References: