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MIND: Artemis in the Removal of Intracerebral Hemorrhage

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ClinicalTrials.gov Identifier: NCT03342664
Recruitment Status : Recruiting
First Posted : November 17, 2017
Last Update Posted : July 2, 2018
Sponsor:
Information provided by (Responsible Party):
Penumbra Inc.

Brief Summary:
The primary objective of this multicenter randomized controlled study is to compare the safety and efficacy of minimally invasive hematoma evacuation with the Artemis Neuro Evacuation Device to best medical management for the treatment of intracerebral hemorrhage (ICH).

Condition or disease Intervention/treatment Phase
Cerebral Hemorrhage Brain Hemorrhage Cerebral Parenchymal Hemorrhage Intracerebral Hemorrhage Device: Artemis + Medical Management Other: Best Medical Management Alone (MM) Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Subjects will be randomized to either minimally invasive hematoma evacuation with the Artemis Neuro Evacuation Device with medical management (MIS group) or best medical management alone (2:1) (MM).
Masking: Single (Outcomes Assessor)
Masking Description: 180 day mRS is blinded
Primary Purpose: Treatment
Official Title: MIND: A Prospective, Multicenter Study of Artemis a Minimally Invasive Neuro Evacuation Device, in the Removal of Intracerebral Hemorrhage
Actual Study Start Date : February 7, 2018
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : February 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Arm Intervention/treatment
Experimental: Artemis + Medical Management (MIS)
Minimally invasive hematoma evacuation with the Artemis Neuro Evacuation Device with medical management
Device: Artemis + Medical Management
Subject will receive best MM in addition to the MIS procedure with Artemis.
Other Name: MIS + MM

Active Comparator: Best Medical Management Alone (MM)
Best medical management alone per standard of care at treating institution
Other: Best Medical Management Alone (MM)
Subject will receive best MM for ICH as determined by stroke physician following AHA/ESO guidelines.
Other Names:
  • MM
  • Control




Primary Outcome Measures :
  1. Functional outcome determined by ordinal modified Rankin score [ Time Frame: 180-day ]
    (0 no symptoms - 5 severe disability)

  2. Rate of mortality [ Time Frame: 30-day ]

Secondary Outcome Measures :
  1. Functional outcomes measured via weighted modified Rankin Score (mRS) [ Time Frame: 180 ]
    (0 no symptoms - 5 severe disability)

  2. Functional outcomes measured via modified Rankin Score (mRS) [ Time Frame: 365 days ]
    (0 no symptoms - 5 severe disability)

  3. Quality of life assessed via Stroke Impact Scale [ Time Frame: 180 and 365 days ]
    Measures mobility and activities of daily living

  4. Quality of life assessed via EQ-5D-5L [ Time Frame: 180 and 365 days ]
    Self assessment on activities of daily living

  5. Length of hospital stay [ Time Frame: Admission to hospital discharge (up to one year) ]
  6. Length of ICU [ Time Frame: # of days from admission (up to one year) ]
  7. Length of procedure [ Time Frame: Time in minutes at the time of surgery (up to one day) ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patient age ≥ 18 and ≤ 80
  2. Supratentorial ICH of volume ≥ 20 and ≤ 80 cc (measured using A x B X C/2 method)
  3. Hemostasis (hemorrhage increase of < 5 cc as confirmed by 2 CT/MR taken a minimum of 6 hours apart)
  4. NIHSS ≥ 6
  5. Presenting GCS ≥ 5 and ≤ 15
  6. Historical mRS 0 or 1
  7. Symptom onset < 24 hours prior to initial CT
  8. MIS must be initiated within 72 hours of ictus/bleed
  9. SBP must be < 180 mmHg and controlled at this level for at least 6 hours

Exclusion Criteria:

  1. Imaging

    1. Expanding hemorrhage on final screening CT/MR scan
    2. "Arterial Spot sign" identified on CTA (may perform additional CTA(s) every 6 hours to demonstrate resolution)
    3. Hemorrhagic lesion such as a vascular malformation (cavernous malformation, AVM etc.), aneurysm, and/or neoplasm
    4. Hemorrhagic conversion of an underlying ischemic stroke
    5. Infratentorial hemorrhage
    6. Associated intra-ventricular hemorrhage requiring treatment for IVHrelated mass effect or shift due to trapped ventricle (EVD for ICP management is allowed)
    7. Midbrain extension/involvement
    8. Absolute contraindication to CTA, conventional angiography and MRA
  2. Coagulation Issues

    1. Absolute requirement for long-term anti-coagulation (e.g., Mechanical valve replacement (bio-prostatic valve is permitted), high risk atrial fibrillation)
    2. Known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency
    3. Platelet count < 100 x 103 cells/mm3 or known platelet dysfunction
    4. 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)
  3. Patient Factors

    1. Traumatic ICH
    2. High risk atrial fibrillation (e.g., mitral stenosis with atrial fibrillation) and/or symptomatic carotid stenosis
    3. Requirement for emergent surgical decompression or uncontrolled ICP after EVD
    4. Unable to obtain consent from patient or legally authorized representative (LAR; for patients without competence)
    5. Pregnancy or positive pregnancy test (either serum or urine). Women of child-bearing potential must have a negative pregnancy test prior to enrollment
    6. Evidence of active infection indicated by fever > 100.7 °F/ 38.2°C and/or open draining wound at the time of randomization
    7. Any comorbid disease or condition expected to compromise survival or ability to complete follow-up assessments through 365 days
    8. Based on investigator's judgement, patient is unwilling or unable to comply with protocol follow up appointment schedule
    9. Active drug or alcohol use or dependence that, in the opinion of the site investigator would interfere with adherence to study requirements
    10. Currently participating in another interventional (drug, device, etc) clinical trial. Patients in observational, natural history, and/or epidemiological studies not involving intervention are eligible.

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): NCT03342664


Contacts
Contact: Brooke Lawson, MS 510-995-2183 blawson@penumbrainc.com
Contact: Michaella Corso 510-995-2079 mcorso@penumbrainc.com

Locations
United States, New Jersey
Atlantic Neuroscience Institute Recruiting
Summit, New Jersey, United States, 07901
Contact: Paul Saphier, MD         
United States, New York
Stony Brook University Recruiting
Stony Brook, New York, United States, 11794
Contact: David Fiorella, MD         
United States, South Carolina
MUSC Recruiting
Charleston, South Carolina, United States, 29425
Contact: Charles Andrews, MD         
United States, Tennessee
Methodist University Hospital Recruiting
Memphis, Tennessee, United States, 38120
Contact: Christopher Nickele, MD         
United States, Washington
Virginia Mason Medical Center Recruiting
Seattle, Washington, United States, 98101
Contact: Robert Ryan, MD         
Sponsors and Collaborators
Penumbra Inc.

Responsible Party: Penumbra Inc.
ClinicalTrials.gov Identifier: NCT03342664     History of Changes
Other Study ID Numbers: 11899
First Posted: November 17, 2017    Key Record Dates
Last Update Posted: July 2, 2018
Last Verified: June 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 Penumbra Inc.:
ICH

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