MIND: Artemis in the Removal of Intracerebral Hemorrhage (NCT03342664) | Clinical Trial Compass
CompletedNot Applicable
MIND: Artemis in the Removal of Intracerebral Hemorrhage
United States236 participantsStarted 2018-02-06
Plain-language 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).
Who can participate
Age range18 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
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)
✕
What they're measuring
1
Global Disability (Functional Outcome) Assessed Via the Ordinal Modified Rankin Score (mRS)
. Associated intra-ventricular hemorrhage requiring treatment for IVH-related mass effect or shift due to trapped ventricle (EVD for ICP management is allowed)