INVEST Feasibility - Minimally Invasive Endoscopic Surgery With Apollo 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 ≥ 22 and ≤ 80, or age < 85 with baseline mRS=0
• Supratentorial ICH of volume ≥ 30 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 to 2
• 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
  • Absolute contraindication to CTA, conventional angiography, and MRA

• 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 deficiency
  • 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 anti-coagulant)

• 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 project.