Brain Hemorrhage, Cerebral Hemorrhage, Cerebral Parenchymal Hemorrhage, Intracerebral Hemorrhage
Conditions
Keywords
ICH, Stroke, Cerebral Hemorrhage, Intracranial Hemorrhage, Hemorrhage, Cerebrovascular Disorders, Brain bleed
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).
Interventions
DEVICEArtemis + Medical Management
Subject will receive best MM in addition to the MIS procedure with Artemis.
OTHERBest Medical Management Alone (MM)
Subject will receive best MM for ICH as determined by stroke physician following AHA/ESO guidelines.
Sponsors
Penumbra Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
180 day mRS is blinded
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).
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Global Disability (Functional Outcome) Assessed Via the Ordinal Modified Rankin Score (mRS) | 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 |
| Rate of Mortality | 30 days | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Functional Outcomes Measured Via Utility Weighted Modified Rankin Score (mRS) | 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: * 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. |
| Functional Outcomes Measured Via Modified Ordinal Rankin Score (mRS) | 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 |
| Quality of Life Assessed Via Stroke Impact Scale | 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. |
| VAS Quality of Life Assessed Via EQ-5D-5L | 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. |
| Length of Hospital Stay | Admission to hospital discharge (up to one year) | — |
| Length of ICU | # of days from admission (up to one year) | — |
| Length of Procedure | Time from initial sheath placement to final sheath removal | — |
| Functional Outcomes Measured Via Modified Rankin Score (mRS) of ≤ 3 | 180 days | (0 no symptoms - 3 moderate disability) |
| Functional Outcomes Measured Via Modified Rankin Score (mRS) of ≤ 2 | 180 days | mRS 0 no symptoms - 2 slight disability |
Countries
Austria, Canada, Germany, United States
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 59.6 Years STANDARD_DEVIATION 11.71 |
| BMI | 30.9 kg/m2 STANDARD_DEVIATION 7.28 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 9 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 115 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 12 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 1 Participants |
| Race/Ethnicity, Customized Asian | 12 Participants |
| Race/Ethnicity, Customized Black or African American | 23 Participants |
| Race/Ethnicity, Customized More Than One Race | 2 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race/Ethnicity, Customized Not Reported | 17 Participants |
| Race/Ethnicity, Customized Other | 3 Participants |
| Race/Ethnicity, Customized Unknown | 5 Participants |
| Race/Ethnicity, Customized White | 147 Participants |
| Region of Enrollment Austria | 1 participants |
| Region of Enrollment Canada | 3 participants |
| Region of Enrollment Germany | 10 participants |
| Region of Enrollment United States | 74 participants |
| Sex: Female, Male Female | 55 Participants |
| Sex: Female, Male Male | 99 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 27 / 154 | 16 / 82 |
| other Total, other adverse events | 107 / 154 | 56 / 82 |
| serious Total, serious adverse events | 89 / 154 | 60 / 82 |
Outcome results
None listed