Clinical trial NCT02661672: INVEST-REGISTRY: Minimally Invasive Endoscopic Surgical Treatment With Apollo/Artemis in Patients With Brain Hemorrhage
Official title: INVEST-REGISTRY: Minimally Invasive Endoscopic Surgical Treatment With Apollo/Artemis in Patients With Brain Hemorrhage: A Prospective Multicenter Registry
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intracranial Hemorrhage
Keywords: Intracranial hemorrhage
Neurosurgery
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: MOUNT SINAI HOSPITAL
name: University at Buffalo
First posted: 2016-01-22
Enrollment: 38
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants With Modified Rankin Score (mRS) ≤ 3 or mRS > 3
timeFrame: 180 days
measure: Number of Participants With Surgical Success Rate
timeFrame: immediately post-procedure
measure: Number of Participants With Surgical Success Rate Regarding IVH
timeFrame: 7 days post-procedure
measure: Rate of Mortality
timeFrame: 30 days post procedure
Secondary outcomes:
measure: Modified Rankin Score (mRS) at 30 Days
timeFrame: 30 days post-procedure
measure: Modified Rankin Score (mRS) at 90 Days
timeFrame: 90 days post-procedure
measure: Length of Hospital Stay
timeFrame: average of 17 days
measure: Number of Participants Requiring VPS
timeFrame: average of 17 days
Other outcomes:
Locations:
city: Washington
country: United States
facility: George Washington University
state: District of Columbia
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
city: Buffalo
country: United States
facility: University of Buffalo
state: New York
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: Danville
country: United States
facility: Geisinger Medical Center
state: Pennsylvania
city: Greenville
country: United States
facility: Prisma Health
state: South Carolina
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: J Mocco, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: