MIND: Artemis in the Removal of Intracerebral Hemorrhage
Status: | Recruiting |
---|---|
Conditions: | Neurology |
Therapuetic Areas: | Neurology |
Healthy: | No |
Age Range: | 18 - 80 |
Updated: | 2/21/2019 |
Start Date: | February 7, 2018 |
End Date: | July 2023 |
Contact: | Brooke Lawson, MS |
Email: | blawson@penumbrainc.com |
Phone: | 510-995-2183 |
MIND: A Prospective, Multicenter Study of Artemis a Minimally Invasive Neuro Evacuation Device, in the Removal of Intracerebral Hemorrhage
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).
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).
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 (hemorrhage increase of < 5 cc as confirmed by 2 CT/MR taken a minimum of 6
hours apart)
4. NIHSS ≥ 6
5. Presenting GCS ≥ 5 and ≤ 15
6. Historical mRS 0 or 1
7. Symptom onset < 24 hours prior to initial CT
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. Expanding hemorrhage on final screening CT/MR scan
2. "Arterial Spot sign" identified on CTA (may perform additional CTA(s) every 6
hours to demonstrate resolution)
3. Hemorrhagic lesion such as a vascular malformation (cavernous malformation, AVM
etc.), aneurysm, and/or neoplasm
4. Hemorrhagic conversion of an underlying ischemic stroke
5. Infratentorial hemorrhage
6. Associated intra-ventricular hemorrhage requiring treatment for IVHrelated 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 103 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)
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 from patient or legally authorized representative (LAR;
for patients without competence)
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. Evidence of active infection indicated by fever > 100.7 °F/ 38.2°C and/or open
draining wound at the time of randomization
7. Any comorbid disease or condition expected to compromise survival or ability to
complete follow-up assessments through 365 days
8. Based on investigator's judgement, patient is unwilling or unable to comply with
protocol follow up appointment schedule
9. Active drug or alcohol use or dependence that, in the opinion of the site
investigator would interfere with adherence to study requirements
10. Currently participating in another interventional (drug, device, etc) clinical
trial. Patients in observational, natural history, and/or epidemiological studies
not involving intervention are eligible.
We found this trial at
5
sites
Virginia Mason Medical Center Established in 1920, Virginia Mason began as an 80-bed hospital with...
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