INVEST-REGISTRY: Minimally Invasive Endoscopic Surgical Treatment With Apollo/Artemis in Patients With Brain Hemorrhage

This is an interventional treatment trial for Intracranial Hemorrhage focused on measuring Intracranial hemorrhage, Neurosurgery Read More

Inclusion Criteria:

• Patient age 022 years or older

• Supratentorial brain hemorrhage, which may be:

  1. Intracerebral (ICH)
  2. Primarily Intracerebral (ICH) with a component of intraventricular hemorrhage (IVH)
  3. Primarily intraventricular hemorrhage (IVH) with a component of ICH
  4. Intraventricular hemorrhage (IVH)
• Patient does not qualify for the concurrent INVEST Feasibility study

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
  • Midbrain extension/involvement

• Coagulation Issues

  • Absolute and imminent (within 7 days of treatment) requirement for long-term, full-dose, anti-coagulation (e.g., Mechanical valve replacement (bio-prostatic valve is permitted), high risk atrial fibrillation)
  • Known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency
  • Uncorrected platelet count < 100 x 103 cells/mm3 or known platelet dysfunction
  • INR > 1.45, elevated prothrombin time or activated partial thromboplastin time (aPTT), which cannot be corrected or otherwise accounted for (i.e., lupus anti-coagulant)

• Patient Factors

  • 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 project.