MIND: Artemis in the Removal of Intracerebral Hemorrhage

MIND: A Prospective, Multicenter Study of Artemis a Minimally Invasive Neuro Evacuation Device, in the Removal of Intracerebral Hemorrhage

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Cerebral Hemorrhage; Intracerebral Hemorrhage; Brain Hemorrhage; Cerebral Parenchymal Hemorrhage
• Intervention / Treatment: Device: Artemis + Medical Management; Other: Best Medical Management Alone (MM)

• Study Type: Interventional
• Enrollment (Estimated): 500
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rahsaan Holley; Phone Number: +1 703-969-3634; Email: rholley@penumbrainc.com
• Study Contact Backup: Name: Brooke Lawson; Phone Number: +1 510 995 2183; Email: blawson@penumbrainc.com

Study Locations

• Austria
  • Salzburg, Austria
    • Uniklinikum Salzburg
• Canada
  • Alberta
    • Edmonton, Alberta, Canada
      • University of Alberta
• Germany
  • Augsburg, Germany
    • Universitatsklinikum Augsburg
  • Berlin, Germany
    • Charité - Universitätsmedizin Berlin
  • Freiburg im Breisgau, Germany
    • Universitatsklinikum Freiburg
  • München, Germany
    • München Klinik Bogenhausen
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85015
      • Abrazo Central
  • California
    • Los Angeles, California, United States, 90095
      • UCLA
    • Mission Viejo, California, United States, 92691
      • Mission Hospital
  • Colorado
    • Englewood, Colorado, United States, 80113
      • Swedish - HCA
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Yale University
  • Delaware
    • Newark, Delaware, United States, 19718
      • Christiana Health
  • District of Columbia
    • Washington, District of Columbia, United States, 20052
      • George Washington
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern Memorial Hospital
    • Chicago, Illinois, United States, 60660
      • Loyola University Chicago
  • Kentucky
    • Lexington, Kentucky, United States, 40506
      • University of Kentucky
    • Louisville, Kentucky, United States, 40292
      • University of Louisville
  • Louisiana
    • New Orleans, Louisiana, United States, 70121
      • Ochsner Medical Center
  • Mississippi
    • Jackson, Mississippi, United States, 39216
      • University of Mississippi
  • Missouri
    • Columbia, Missouri, United States, 65211
      • University of Missouri
  • New Jersey
    • Summit, New Jersey, United States, 07901
      • Atlantic Neuroscience Institute
  • New York
    • Brooklyn, New York, United States, 11219
      • Maimonides
    • Manhasset, New York, United States, 11030
      • Northwell Health
    • New York, New York, United States, 10029
      • Mount Sinai
    • Stony Brook, New York, United States, 11794
      • Stony Brook University
  • North Carolina
    • Charlotte, North Carolina, United States, 28277
      • Novant Health
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • University Hospital Cleveland
  • Pennsylvania
    • Danville, Pennsylvania, United States, 17822
      • Geisinger Medical Center
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • MUSC
  • Tennessee
    • Memphis, Tennessee, United States, 38120
      • Methodist University Hospital
  • Texas
    • Harlingen, Texas, United States, 78520
      • Valley Baptist Medical Center
  • Washington
    • Seattle, Washington, United States, 98104
      • Harborview Medical Center
    • Seattle, Washington, United States, 98101
      • Virginia Mason Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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: Control; MM

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Global disability (functional outcome) assessed via the ordinal modified Rankin score (mRS)	(0 no symptoms - 5 severe disability)	180 days
Rate of mortality		30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional outcomes measured via weighted modified Rankin Score (mRS)	(0 no symptoms - 5 severe disability)	180 days
Functional outcomes measured via modified Rankin Score (mRS)	(0 no symptoms - 5 severe disability)	365 days
Quality of life assessed via Stroke Impact Scale	Measures mobility and activities of daily living	180 and 365 days
Quality of life assessed via EQ-5D-5L	Self assessment on activities of daily living	180 and 365 days
Length of hospital stay		Admission to hospital discharge (up to one year)
Length of ICU		# of days from admission (up to one year)
Length of procedure		Time in minutes at the time of surgery (up to one day)
Functional outcomes measured via modified Rankin Score (mRS) of ≤ 3	(0 no symptoms - 5 severe disability)	180 days
Functional outcomes measured via modified Rankin Score (mRS) of ≤ 2	(0 no symptoms - 5 severe disability)	180 days

Collaborators and Investigators

• Sponsor: Penumbra Inc.

Study record dates

Study Major Dates

• Study Start (Actual): February 7, 2018
• Primary Completion (Estimated): May 1, 2024
• Study Completion (Estimated): November 1, 2024

Study Registration Dates

• First Submitted: October 18, 2017
• First Submitted That Met QC Criteria: November 13, 2017
• First Posted (Actual): November 17, 2017

Study Record Updates

• Last Update Posted (Actual): February 9, 2024
• Last Update Submitted That Met QC Criteria: February 7, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Stroke; ICH; Cerebral Hemorrhage; Hemorrhage; Cerebrovascular Disorders; Intracranial Hemorrhage; Brain bleed
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hemorrhage; Intracranial Hemorrhages; Cerebral Hemorrhage
• Other Study ID Numbers: 11899

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes