Clinical trial NCT02654015: INVEST Feasibility - Minimally Invasive Endoscopic Surgery With Apollo in Patients With Brain Hemorrhage
Official title: INVEST: A Single Arm, Feasibility Study of Minimally Invasive Endoscopic Surgical Treatment With Apollo for Supratentorial Intracerebral Hemorrhage (ICH)
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: 2016-01-13
Enrollment: 50
Sex: ALL
Minimum age (years): 22
Maximum age (years): 84
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary objective of this multicenter single arm feasibility study is to provide an assessment of enrollment and follow up feasibility for this patient population being treated with the Apollo Minimally Invasive Surgical Treatment (MIES). Patients who do not qualify for the INVEST Feasibility Study will be referred to the INVEST Registry study.

Detailed description: Objective: The primary objective of this multicenter single arm feasibility study is to provide an assessment of enrollment and follow up feasibility for this patient population being treated with the Apollo or Artemis Minimally Invasive Surgical Treatment (MIES). Patients who do not qualify for the INVEST Feasibility Study will be referred to the INVEST Registry study.

Study Design: This study will be a prospective, multi-centered trial that will enroll 50 patients at up to 10 United States (US) centers.

Patient Population: Patients with moderate-large volume (20-80 cc) supratentorial intracerebral hemorrhage (ICH) who present within 24 hours of symptom onset. Enrolled patients will receive minimally invasive endoscopic evacuation with the Apollo system or Artemis Device.

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 or cerebrum. In the present study, the researchers propose to investigate the feasibility of studying this patient population for eventual implementation of efficacy trials.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants Enrolled Within 730 Days of First Enrollment
timeFrame: 730 days
measure: Number of Participants With Available mRS Score
timeFrame: 180 days
Secondary outcomes:
measure: Stroke Impact Scale - Mobility
timeFrame: 180 days
measure: Stroke Impact Scale - ADLs
timeFrame: 180 days
measure: EQ-5D-5L
timeFrame: 180 days
measure: Length of Hospital Stay
timeFrame: average of 14 days
measure: Number of Participants With Modified Rankin Score (mRS) Less Than or Equal to 3
timeFrame: 180 days
measure: Number of Participants Who Meet Both Criteria of Reduction of Hemorrhage Volume
timeFrame: 180 days
measure: Number of Participants With IVH (mGraeb > 0) With an mGraeb Score of Less Than or Equal to 5
timeFrame: Day 7
measure: Number of Participants Who Died Within 90 Days of the Procedure
timeFrame: 90 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: