Artemis + Medical Management
DeviceSubject will receive best MM in addition to the MIS procedure with Artemis.
Other names: MIS + MM
NCT Number: NCT03342664
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).
Looking for future studies?
Notify Me18 year–80 year
All sexes
Interventional
Not applicable
Uniklinikum Salzburg, Salzburg, Austria
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Subject will receive best MM in addition to the MIS procedure with Artemis.
Other names: MIS + MM
Subject will receive best MM for ICH as determined by stroke physician following AHA/ESO guidelines.
Other names: MM, Control
Time frame: 180 days
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: 30 days
Time frame: 180 days
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:
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:
Higher scores indicate better functional outcomes. Lower scores indicate worse functional outcomes.
Time frame: 365 days
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 and 365 days
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.
Time frame: 180 and 365 days
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: Admission to hospital discharge (up to one year)
Time frame: # of days from admission (up to one year)
Time frame: Time from initial sheath placement to final sheath removal
Time frame: 180 days
(0 no symptoms - 3 moderate disability)
Time frame: 180 days
mRS 0 no symptoms - 2 slight disability
Penumbra Inc.
Industry
MIND: A Prospective, Multicenter Study of Artemis a Minimally Invasive Neuro Evacuation Device, in the Removal of Intracerebral Hemorrhage
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT02880878
Brain Diseases, Cardiovascular Diseases
Birmingham, Alabama, United States
View Trial DetailsNCT03209258
Anticoagulant-induced Bleeding, Brain Diseases
Chengdu, Sichuan, China
View Trial DetailsNCT07665827
Brain Diseases, Cardiovascular Diseases
Beijing, Beijing Municipality, China
View Trial DetailsNCT06668441
Brain Diseases, Cardiovascular Diseases
Beijing, Beijing Municipality, China
View Trial Details