Clinical Trial Details
Braintumor Website

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NCT02654015 : INVEST: Minimally Invasive Endoscopic Surgery vs. Medical Management in Supratentorial Intraparenchymal Hemorrhage
PhasePhase 2
AgesMin: 18 Years Max: 80 Years
Inclusion Criteria:

- Patient age ? 18 and ? 80, or age < 85 with baseline mRS=0

- Supratentorial ICH of volume ? 20 mL < 80 ml (measured using A x B X C/2 method)

- CT/MR demonstrates ICH stability (< 5 cc growth) at 6 hours after admission scan

- If the initial stability scan shows growth, a second stability scan can be performed
q12h until stability is demonstrated or until eligibility for the study has lapsed.

- NIHSS ? 6

- Presenting GCS 5 - 15

- Historical mRS 0 or 1

- Symptom onset < 24 h prior initial CT

- Apollo MIES can be initiated within 72h of ictus/bleed

- SBP can be controlled < 160 mmHg and sustained at this level for at least 6 hours

Exclusion Criteria:

- Imaging

- Expanding hemorrhage on stability CT/MR scan

- "Spot sign" identified on CTA (May perform a second CTA at 12 hours to
demonstrate resolution)

- Hemorrhagic lesion such as a vascular malformation (cavernous malformation, AVM
etc), aneurysm, neoplasm

- Hemorrhagic conversion of an underlying ischemic stroke

- Infratentorial hemorrhage

- Large associated intra-ventricular hemorrhage requiring treatment for
IVH-related mass effect or shift due to trapped ventricle (EVD for ICP
management is allowed)

- Midbrain extension/involvement

- Coagulation Issues

- Absolute requirement for long-term anti-coagulation (e.g., Mechanical valve
replacement (bio-prostatic valve is permitted), high risk atrial fibrillation)

- Known hereditary or acquired hemorrhagic diathesis, coagulation factor

- Platelet count < 100 x 103 cells/mm3 or known platelet dysfunction

- INR > 1.4, elevated prothrombin time or activated partial thromboplastin time
(aPTT), which cannot be corrected or otherwise accounted for (i.e., lupus

- Patient Factors

- Presenting GCS 3 or 4.

- High risk condition for ischemic stroke (high risk Afib (e.g., mitral stenosis
with Afib), symptomatic carotid stenosis)

- Requirement for emergent surgical decompression or uncontrolled ICP after EVD

- Unable to obtain consent from patient or appropriate surrogate (for patients
without competence)

- Pregnancy, breast-feeding, or positive pregnancy test [either serum or urine]
(Woman of child-bearing potential must have a negative pregnancy test prior to
the study procedure.)

- Evidence of active infection [indicated by fever (at or over 100.7 °F) and/or
open draining wound] at the time of randomization

- Any comorbid disease or condition expected to compromise survival or ability to
complete follow-up assessments through 180 days.

- Based on investigator's judgment, patient does not have the necessary mental
capacity to participate or 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) research
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