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

J. Mocco

Status: Completed

Conditions: Intracranial Hemorrhage

Treatments: Device: Apollo Device; Device: Artemis Device

Study type: Interventional

Funder types: Other

Identifiers

NCT02661672

GCO 16-0028

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 38 patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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38 participants in 1 patient group

Patients with Brain Hemorrhage

Experimental group

Description:

Subjects will receive best medical management for ICH plus they will receive the MIES surgery and use of the Apollo or Artemis System for clot evacuation.

Treatment:

Device: Artemis Device

Device: Apollo Device