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MIND: Artemis in the Removal of Intracerebral 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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03342664
Recruitment Status : Recruiting
First Posted : November 17, 2017
Last Update Posted : January 26, 2022
Sponsor:
Information provided by (Responsible Party):
Penumbra Inc.

Tracking Information
First Submitted Date  ICMJE October 18, 2017
First Posted Date  ICMJE November 17, 2017
Last Update Posted Date January 26, 2022
Actual Study Start Date  ICMJE February 7, 2018
Estimated Primary Completion Date July 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 17, 2019)
  • Global disability (functional outcome) assessed via the ordinal modified Rankin score (mRS) [ Time Frame: 180 days ]
    (0 no symptoms - 5 severe disability)
  • Rate of mortality [ Time Frame: 30 days ]
Original Primary Outcome Measures  ICMJE
 (submitted: November 13, 2017)
  • Functional outcome determined by ordinal modified Rankin score [ Time Frame: 180-day ]
    (0 no symptoms - 5 severe disability)
  • Rate of mortality [ Time Frame: 30-day ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 17, 2019)
  • Functional outcomes measured via weighted modified Rankin Score (mRS) [ Time Frame: 180 days ]
    (0 no symptoms - 5 severe disability)
  • Functional outcomes measured via modified Rankin Score (mRS) [ Time Frame: 365 days ]
    (0 no symptoms - 5 severe disability)
  • Quality of life assessed via Stroke Impact Scale [ Time Frame: 180 and 365 days ]
    Measures mobility and activities of daily living
  • Quality of life assessed via EQ-5D-5L [ Time Frame: 180 and 365 days ]
    Self assessment on activities of daily living
  • Length of hospital stay [ Time Frame: Admission to hospital discharge (up to one year) ]
  • Length of ICU [ Time Frame: # of days from admission (up to one year) ]
  • Length of procedure [ Time Frame: Time in minutes at the time of surgery (up to one day) ]
  • Functional outcomes measured via modified Rankin Score (mRS) of ≤ 3 [ Time Frame: 180 days ]
    (0 no symptoms - 5 severe disability)
  • Functional outcomes measured via modified Rankin Score (mRS) of ≤ 2 [ Time Frame: 180 days ]
    (0 no symptoms - 5 severe disability)
Original Secondary Outcome Measures  ICMJE
 (submitted: November 13, 2017)
  • Functional outcomes measured via weighted modified Rankin Score (mRS) [ Time Frame: 180 ]
    (0 no symptoms - 5 severe disability)
  • Functional outcomes measured via modified Rankin Score (mRS) [ Time Frame: 365 days ]
    (0 no symptoms - 5 severe disability)
  • Quality of life assessed via Stroke Impact Scale [ Time Frame: 180 and 365 days ]
    Measures mobility and activities of daily living
  • Quality of life assessed via EQ-5D-5L [ Time Frame: 180 and 365 days ]
    Self assessment on activities of daily living
  • Length of hospital stay [ Time Frame: Admission to hospital discharge (up to one year) ]
  • Length of ICU [ Time Frame: # of days from admission (up to one year) ]
  • Length of procedure [ Time Frame: Time in minutes at the time of surgery (up to one day) ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE MIND: Artemis in the Removal of Intracerebral Hemorrhage
Official Title  ICMJE MIND: A Prospective, Multicenter Study of Artemis a Minimally Invasive Neuro Evacuation Device, in the Removal of Intracerebral Hemorrhage
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE
  • Cerebral Hemorrhage
  • Brain Hemorrhage
  • Cerebral Parenchymal Hemorrhage
  • Intracerebral Hemorrhage
Intervention  ICMJE
  • Device: Artemis + Medical Management
    Subject will receive best MM in addition to the MIS procedure with Artemis.
    Other Name: MIS + MM
  • 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
Study Arms  ICMJE
  • Experimental: Artemis + Medical Management (MIS)
    Minimally invasive hematoma evacuation with the Artemis Neuro Evacuation Device with medical management
    Intervention: Device: Artemis + Medical Management
  • Active Comparator: Best Medical Management Alone (MM)
    Best medical management alone per standard of care at treating institution
    Intervention: Other: Best Medical Management Alone (MM)
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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 13, 2017)
500
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2026
Estimated Primary Completion Date July 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 as confirmed by no arterial spot sign (may perform additional scan(s) every 6 hours to demonstrate hemostasis)
  4. NIHSS ≥ 6
  5. GCS ≥ 5 and ≤ 15
  6. Historical mRS 0 or 1
  7. Symptom onset < 24 hours prior to initial CT/MR
  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. "Arterial Spot Sign" identified on final CTA indicating expanding hemorrhage
    2. Hemorrhagic lesion such as a vascular malformation (cavernous malformation, AVM etc.), aneurysm, and/or neoplasm
    3. Hemorrhagic conversion of an underlying ischemic stroke
    4. Infratentorial hemorrhage
    5. Primary thalamic ICH (where the center of the hemorrhage emulates from the thalamus)
    6. Associated intra-ventricular hemorrhage requiring treatment for IVH-related 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 10^3 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)
    5. Use of direct factor Xa inhibitors (e.g. apixaban, rivaroxaban, fondaparinux) within last 48 hours
  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 per Institution Review Board/Ethics Committee policy
    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. Severe active infection requiring treatment (e.g. sepsis or purulent wound) at the time of enrollment
    7. Renal failure indicated by creatinine > 2 mg/dL or undergoing dialysis
    8. Any comorbid disease or condition expected to compromise survival or ability to complete follow-up assessments through 365 days
    9. Based on investigator's judgement, patient is unwilling or unable to comply with protocol follow up appointment schedule
    10. Active drug or alcohol use or dependence that, in the opinion of the site investigator would interfere with adherence to study requirements
    11. Currently participating in another interventional (drug, device, etc) clinical trial. Patients in observational, natural history, and/or epidemiological studies not involving intervention are eligible.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Marisol Clemens +1 510 995 2494 mclemens@penumbrainc.com
Contact: Brooke Lawson +1 510 995 2183 blawson@penumbrainc.com
Listed Location Countries  ICMJE Canada,   Germany,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03342664
Other Study ID Numbers  ICMJE 11899
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 Penumbra Inc.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Penumbra Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Penumbra Inc.
Verification Date January 2022

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