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INVEST Feasibility - Minimally Invasive Endoscopic Surgery With Apollo in Patients With Brain Hemorrhage

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ClinicalTrials.gov Identifier: NCT02654015
Recruitment Status : Recruiting
First Posted : January 13, 2016
Last Update Posted : December 6, 2018
Sponsor:
Collaborators:
MOUNT SINAI HOSPITAL
University at Buffalo
Information provided by (Responsible Party):
J. Mocco, Icahn School of Medicine at Mount Sinai

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.

Condition or disease Intervention/treatment Phase
Intracranial Hemorrhage Device: Apollo MIES Other: Medical Management Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: INVEST: A Single Arm, Feasibility Study of Minimally Invasive Endoscopic Surgical Treatment With Apollo for Supratentorial Intracerebral Hemorrhage (ICH)
Actual Study Start Date : June 30, 2017
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Arm Intervention/treatment
Experimental: Medical Management plus Apollo MIES
Subjects will receive best medical management for ICH plus they will receive the MIES surgery and use of the Apollo System for clot evacuation.
Device: Apollo MIES
Subjects will receive best medical management plus MIES (minimally invasive endoscopic surgery with use of the Apollo System.
Other Name: ICH - Apollo System

Other: Medical Management
Subjects will receive best medical management for intracranial hemorrhage
Other Names:
  • MM
  • ICH - Medical Management




Primary Outcome Measures :
  1. Rate of recruitment [ Time Frame: 730 days ]
    following first patient enrollment

  2. Rate of successful follow up obtainment [ Time Frame: 180 days ]
    Follow up of patients


Secondary Outcome Measures :
  1. Stroke Impact Scale - Mobility [ Time Frame: 180 days ]

    For each item, the individual is asked to rate the level of difficulty of the item in the past 2 weeks using the following scale:

    • 1 = could not do it at all
    • 2 = very difficult
    • 3 = somewhat difficult
    • 4 = a little difficult
    • 5 = not difficult at all

  2. Stroke Impact Scale - ADLs [ Time Frame: 180 days ]

    For each item, the individual is asked to rate the level of difficulty of the item in the past 2 weeks using the following scale:

    • 1 = could not do it at all
    • 2 = very difficult
    • 3 = somewhat difficult
    • 4 = a little difficult
    • 5 = not difficult at all

  3. EQ-5D-5L [ Time Frame: 180 days ]
    EQ-5D is a standardised measure of health status developed by the EuroQol Group in order to provide a simple, generic measure of health for clinical and economic appraisal. EQ-5D-5L health states, defined by the EQ-5D-5L descriptive system, may be converted into a single index value. scored as 1 = no problem to 5 = severe problem

  4. Length of hospital stay [ Time Frame: average of 180 days ]
    number of days of hospital stay

  5. Clinical Efficacy Endpoint [ Time Frame: 180 days ]
    Global disability assessed via the modified Rankin score (mRS), categorized as either mRS < 3 or mRS > 3

  6. Rate of surgical success [ Time Frame: 180 days ]
    Technical Efficacy Endpoint

  7. Hemorrhage volume [ Time Frame: 180 days ]
    Predominantly or Only ICH: Reduction to < 15 cc total volume AND >60% reduction in hemorrhage volume on immediate post-treatment CT scan

  8. MGraeb score [ Time Frame: Day 7 ]
    Predominantly or Only IVH: mGraeb score of < 5 on day 7 CT scan

  9. Rate of mortality [ Time Frame: 90 days ]
    Safety Endpoint



Information from the National Library of Medicine

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Ages Eligible for Study:   22 Years to 84 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02654015


Contacts
Contact: J Mocco, MD, MS 212-241-4007 j.mocco@mountsinai.org

Locations
United States, New York
Icahn School of Medicine at Mount Sinai Recruiting
New York, New York, United States, 10029
Contact: J Mocco, MD, MS       j.mocco@mountsinai.org   
Contact: Ashley Friend, MS    212-241-2376    ashley.friend@mountsinai.org   
Principal Investigator: J Mocco, MD         
Sponsors and Collaborators
J. Mocco
MOUNT SINAI HOSPITAL
University at Buffalo
Investigators
Principal Investigator: J Mocco, MD, MS Icahn School of Medicine at Mount Sinai

Responsible Party: J. Mocco, Professor, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT02654015     History of Changes
Other Study ID Numbers: GCO 16-0027
First Posted: January 13, 2016    Key Record Dates
Last Update Posted: December 6, 2018
Last Verified: December 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

Keywords provided by J. Mocco, Icahn School of Medicine at Mount Sinai:
intracranial hemorrhage
neurosurgery

Additional relevant MeSH terms:
Hemorrhage
Intracranial Hemorrhages
Pathologic Processes
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases