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Trial record 7 of 179 for:    DCLRE1C

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

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ClinicalTrials.gov Identifier: NCT02661672
Recruitment Status : Recruiting
First Posted : January 22, 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:
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.

Condition or disease Intervention/treatment Phase
Intracranial Hemorrhage Device: Apollo Device Device: Artemis Device Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: INVEST-REGISTRY: Minimally Invasive Endoscopic Surgical Treatment With Apollo/Artemis in Patients With Brain Hemorrhage: A Prospective Multicenter Registry
Study Start Date : October 2016
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: Patients with Brain Hemorrhage
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.
Device: Apollo Device
The Apollo system has been cleared for the controlled aspiration of soft tissue and/or fluid during endoscopically guided neurosurgery of the ventricular system.
Other Name: ICH - Apollo System

Device: Artemis Device
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.




Primary Outcome Measures :
  1. modified Rankin score (mRS) [ Time Frame: 180 days ]
    Clinical Efficacy Endpoint: global disability assessed via the modified Rankin score (mRS)

  2. Surgical success rate [ Time Frame: 180 days ]
    Technical Efficacy Endpoint measured by rate of surgical success

  3. Rate of Mortality [ Time Frame: 30 days ]


Information from the National Library of Medicine

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

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): NCT02661672


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

Locations
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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    212-241-2376    ashley.friend@mountsinai.org   
Principal Investigator: J Mocco, MD, MS         
Sponsors and Collaborators
J. Mocco
MOUNT SINAI HOSPITAL
University at Buffalo
Investigators
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Principal Investigator: J Mocco, MD, MS Icahn School of Medicine at Mount Sinai

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Responsible Party: J. Mocco, Professor, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT02661672     History of Changes
Other Study ID Numbers: GCO 16-0028
First Posted: January 22, 2016    Key Record Dates
Last Update Posted: December 6, 2018
Last Verified: December 2018

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

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