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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
236
Subject will receive best MM in addition to the MIS procedure with Artemis.
Subject will receive best MM for ICH as determined by stroke physician following AHA/ESO guidelines.
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
Time frame: 180 days
Rate of Mortality
Time frame: 30 days
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.
Time frame: 180 days
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
Time frame: 365 days
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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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
...and 23 more locations
Time frame: 180 and 365 days
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.
Time frame: 180 and 365 days
Length of Hospital Stay
Time frame: Admission to hospital discharge (up to one year)
Length of ICU
Time frame: # of days from admission (up to one year)
Length of Procedure
Time frame: Time from initial sheath placement to final sheath removal
Functional Outcomes Measured Via Modified Rankin Score (mRS) of ≤ 3
(0 no symptoms - 3 moderate disability)
Time frame: 180 days
Functional Outcomes Measured Via Modified Rankin Score (mRS) of ≤ 2
mRS 0 no symptoms - 2 slight disability
Time frame: 180 days