N/A
N=236
MIND: Artemis in the Removal of Intracerebral Hemorrhage
Cerebral Hemorrhage · Brain Hemorrhage · Cerebral Parenchymal Hemorrhage · Intracerebral Hemorrhage
Bottom Line
View on ClinicalTrials.gov: NCT03342664 ↗Enrolled (actual)
236
Serious AEs
63.1%
Results posted
Jan 2026
Primary outcome: Primary: Global Disability (Functional Outcome) Assessed Via the Ordinal Modified Rankin Score (mRS) — 32; 20; 4; 2 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Artemis + Medical Management (Device); Best Medical Management Alone (MM) (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Penumbra Inc.
- Primary completion
- Feb 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Global Disability (Functional Outcome) Assessed Via the Ordinal Modified Rankin Score (mRS) |
32; 20; 4; 2; 5; 1 | — |
| PRIMARY Rate of Mortality |
11; 8 | — |
| SECONDARY Functional Outcomes Measured Via Utility Weighted Modified Rankin Score (mRS) |
0.41; 0.38 | — |
| SECONDARY Functional Outcomes Measured Via Modified Ordinal Rankin Score (mRS) |
15; 12; 4; 0; 15; 6 | — |
| SECONDARY Quality of Life Assessed Via Stroke Impact Scale |
54.3; 53.9; 53.4; 53.8; 55.0; 58.4 | — |
| SECONDARY VAS Quality of Life Assessed Via EQ-5D-5L |
61.6; 62.4; 62.7; 66.0 | — |
| SECONDARY Length of Hospital Stay |
18.8; 20.6 | — |
| SECONDARY Length of ICU |
7.6; 9.2 | — |
| SECONDARY Length of Procedure |
41; 34 | — |
| SECONDARY Functional Outcomes Measured Via Modified Rankin Score (mRS) of ≤ 3 |
57; 32 | — |
| SECONDARY Functional Outcomes Measured Via Modified Rankin Score (mRS) of ≤ 2 |
26; 14 | — |
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
- 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 1.4, elevated prothrombin time or activated partial thromboplastin time (aPTT), which cannot be corrected or otherwise accounted for (i.e., lupus anti-coagulant)
- Use of direct factor Xa inhibitors (e.g. apixaban, rivaroxaban, fondaparinux) within last 48 hours
- Patient Factors
- Traumatic ICH
- High risk atrial fibrillation (e.g., mitral stenosis with atrial fibrillation) and/or symptomatic carotid stenosis
- Requirement for emergent surgical decompression or uncontrolled ICP after EVD
- Unable to obtain consent per Institution Review Board/Ethics Committee policy
- Pregnancy or positive pregnancy test (either serum or urine). Women of child-bearing potential must have a negative pregnancy test prior to enrollment
- Severe active infection requiring treatment (e.g. sepsis or purulent wound) at the time of enrollment
- Renal failure indicated by creatinine > 2 mg/dL or undergoing dialysis
- Any comorbid disease or condition expected to compromise survival or ability to complete follow-up assessments through 365 days
- Based on investigator's judgement, patient is unwilling or unable to comply with protocol follow up appointment schedule
- Active drug or alcohol use or dependence that, in the opinion of the site investigator would interfere with adherence to study requirements
- Currently participating in another interventional (drug, device, etc) clinical trial. Patients in observational, natural history, and/or epidemiological studies not involving intervention are eligible.
Data sourced from ClinicalTrials.gov (NCT03342664). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.