We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02654015
Recruitment Status : Active, not recruiting
First Posted : January 13, 2016
Last Update Posted : April 14, 2022
Sponsor:
Collaborators:
MOUNT SINAI HOSPITAL
University at Buffalo
Information provided by (Responsible Party):
J. Mocco, Icahn School of Medicine at Mount Sinai

Tracking Information
First Submitted Date  ICMJE January 11, 2016
First Posted Date  ICMJE January 13, 2016
Last Update Posted Date April 14, 2022
Actual Study Start Date  ICMJE June 30, 2017
Estimated Primary Completion Date June 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 10, 2017)
  • Rate of recruitment [ Time Frame: 730 days ]
    following first patient enrollment
  • Rate of successful follow up obtainment [ Time Frame: 180 days ]
    Follow up of patients
Original Primary Outcome Measures  ICMJE
 (submitted: January 12, 2016)
  • modified Rankin score (mRS) [ Time Frame: 180 days ]
    disability assessed via the modified Rankin score (mRS)
  • Rate of mortality [ Time Frame: 30 days ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 10, 2017)
  • 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
  • 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
  • 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
  • Length of hospital stay [ Time Frame: average of 180 days ]
    number of days of hospital stay
  • Clinical Efficacy Endpoint [ Time Frame: 180 days ]
    Global disability assessed via the modified Rankin score (mRS), categorized as either mRS < 3 or mRS > 3
  • Rate of surgical success [ Time Frame: 180 days ]
    Technical Efficacy Endpoint
  • 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
  • MGraeb score [ Time Frame: Day 7 ]
    Predominantly or Only IVH: mGraeb score of < 5 on day 7 CT scan
  • Rate of mortality [ Time Frame: 90 days ]
    Safety Endpoint
Original Secondary Outcome Measures  ICMJE
 (submitted: January 12, 2016)
  • 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
  • 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
  • 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
  • Length of hospital stay [ Time Frame: average of 180 days ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE INVEST Feasibility - Minimally Invasive Endoscopic Surgery With Apollo in Patients With Brain Hemorrhage
Official Title  ICMJE INVEST: A Single Arm, Feasibility Study of Minimally Invasive Endoscopic Surgical Treatment With Apollo for Supratentorial Intracerebral Hemorrhage (ICH)
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Intracranial Hemorrhage
Intervention  ICMJE
  • 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
Study Arms  ICMJE 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.
Interventions:
  • Device: Apollo MIES
  • Other: Medical Management
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: April 10, 2017)
50
Original Estimated Enrollment  ICMJE
 (submitted: January 12, 2016)
222
Estimated Study Completion Date  ICMJE June 2022
Estimated Primary Completion Date June 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 22 Years to 84 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02654015
Other Study ID Numbers  ICMJE GCO 16-0027
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party J. Mocco, Icahn School of Medicine at Mount Sinai
Original Responsible Party Same as current
Current Study Sponsor  ICMJE J. Mocco
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • MOUNT SINAI HOSPITAL
  • University at Buffalo
Investigators  ICMJE
Principal Investigator: J Mocco, MD, MS Icahn School of Medicine at Mount Sinai
PRS Account Icahn School of Medicine at Mount Sinai
Verification Date April 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP