INVEST-REGISTRY: Minimally Invasive Endoscopic Surgical Treatment With Apollo/Artemis in Patients With Brain Hemorrhage
INVEST-REGISTRY: Minimally Invasive Endoscopic Surgical Treatment With Apollo/Artemis in Patients With Brain Hemorrhage
Objective: The primary objective of this multicenter prospective registry is to provide
 additional safety, technical outcomes and clinical outcomes data for minimally invasive
 endoscopic surgery (MIES) with Apollo or Artemis for the evacuation of supratentorial brain
 hemorrhage in adult patients who do not qualify for the concurrent INVEST Feasibility
 randomized controlled trial at active INVEST centers.
Study Design: This study will be a prospective, non-randomized, multi-center, single arm
 registry that will enroll up to 50 patients, however may increase to 200 at up to 10 US
 centers.

 Patient Population: Adult patients with supratentorial brain hemorrhages (ICH and/or IVH) who
 do not meet all INCLUSION criteria or who meet one or more EXCLUSION criteria for the INVEST
 trial, but who will ultimately undergo MIES with Apollo or Artemis at active INVEST centers.

 Indication: The Artemis Neuro Evacuation Device is used for the controlled aspiration of
 tissue and/or fluid during surgery of the Ventricular System or Cerebrum in conjunction with
 a Penumbra Aspiration Pump. The Penumbra Aspiration Pump is indicated as a vacuum source for
 the Penumbra Aspiration Systems. The Apollo system has been cleared for the controlled
 aspiration of soft tissue and/or fluid during endoscopically guided neurosurgery of the
 ventricular system. In the present study, the researchers propose to investigate the safety
 and efficacy of this system for the minimally invasive evacuation of brain hemorrhage - both
 IVH, IVH with ICH and ICH alone - in patients who do not qualify for the INVEST trial.
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.