MIND: Artemis in the Removal of Intracerebral Hemorrhage

Not Applicable

Active, not recruiting

• Conditions: Intracerebral Hemorrhage; Cerebral Parenchymal Hemorrhage; Cerebral Hemorrhage; Brain Hemorrhage
• Interventions: Other: Best Medical Management Alone (MM); Device: Artemis + Medical Management

• Registration Number: NCT03342664
• Lead Sponsor: 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-10-18
• Study First Submitted QC: 2017-11-13
• Study First Posted: 2017-11-17
• Study Start: 2018-02-07
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-07
• Last Update Posted: 2024-02-09
• Primary Completion: 2024-05
• Study Completion: 2024-11

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 500

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Best Medical Management Alone (MM)	Best Medical Management Alone (MM)	Best medical management alone per standard of care at treating institution
Artemis + Medical Management (MIS)	Artemis + Medical Management	Minimally invasive hematoma evacuation with the Artemis Neuro Evacuation Device with medical management

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (33)

University Hospital Cleveland; 🇺🇸 Cleveland, Ohio, United States

UCLA; 🇺🇸 Los Angeles, California, United States

Swedish - HCA; 🇺🇸 Englewood, Colorado, United States

Northwestern Memorial Hospital; 🇺🇸 Chicago, Illinois, United States

Loyola University Chicago; 🇺🇸 Chicago, Illinois, United States

Northwell Health; 🇺🇸 Manhasset, New York, United States

Geisinger Medical Center; 🇺🇸 Danville, Pennsylvania, United States

Harborview Medical Center; 🇺🇸 Seattle, Washington, United States

Uniklinikum Salzburg; 🇦🇹 Salzburg, Austria

University of Kentucky; 🇺🇸 Lexington, Kentucky, United States

University of Mississippi; 🇺🇸 Jackson, Mississippi, United States

Mission Hospital; 🇺🇸 Mission Viejo, California, United States

Christiana Health; 🇺🇸 Newark, Delaware, United States

George Washington; 🇺🇸 Washington, District of Columbia, United States

Ochsner Medical Center; 🇺🇸 New Orleans, Louisiana, United States

University of Missouri; 🇺🇸 Columbia, Missouri, United States

Atlantic Neuroscience Institute; 🇺🇸 Summit, New Jersey, United States

Maimonides; 🇺🇸 Brooklyn, New York, United States

Mount Sinai; 🇺🇸 New York, New York, United States

Stony Brook University; 🇺🇸 Stony Brook, New York, United States

Novant Health; 🇺🇸 Charlotte, North Carolina, United States

Methodist University Hospital; 🇺🇸 Memphis, Tennessee, United States

Valley Baptist Medical Center; 🇺🇸 Harlingen, Texas, United States

Virginia Mason Medical Center; 🇺🇸 Seattle, Washington, United States

University of Alberta; 🇨🇦 Edmonton, Alberta, Canada

Universitätsklinikum Augsburg; 🇩🇪 Augsburg, Germany

Universitätsklinikum Freiburg; 🇩🇪 Freiburg im Breisgau, Germany

Charité - Universitätsmedizin Berlin; 🇩🇪 Berlin, Germany

München Klinik Bogenhausen; 🇩🇪 München, Germany

Abrazo Central; 🇺🇸 Phoenix, Arizona, United States

Yale University; 🇺🇸 New Haven, Connecticut, United States

University of Louisville; 🇺🇸 Louisville, Kentucky, United States

MUSC; 🇺🇸 Charleston, South Carolina, United States