MIND: Artemis in the Removal of Intracerebral Hemorrhage

Intracerebral Hemorrhage Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03342664
• Other study ID #: 11899
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 7, 2018
• Est. completion date: November 2024

Study information

• Verified date: February 2024
• Source: Penumbra Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 500
• Est. completion date: November 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Brain Hemorrhage
• Cerebral Hemorrhage
• Cerebral Parenchymal Hemorrhage
• Hemorrhage
• Intracerebral Hemorrhage
• Intracranial Hemorrhages

Intervention

Device:
• Artemis + Medical Management
Subject will receive best MM in addition to the MIS procedure with Artemis.

Other:
• Best Medical Management Alone (MM)
Subject will receive best MM for ICH as determined by stroke physician following AHA/ESO guidelines.

Locations

Country	Name	City	State
Austria	Uniklinikum Salzburg	Salzburg
Canada	University of Alberta	Edmonton	Alberta
Germany	Universitätsklinikum Augsburg	Augsburg
Germany	Charité - Universitätsmedizin Berlin	Berlin
Germany	Universitätsklinikum Freiburg	Freiburg im Breisgau
Germany	München Klinik Bogenhausen	München
United States	Maimonides	Brooklyn	New York
United States	MUSC	Charleston	South Carolina
United States	Novant Health	Charlotte	North Carolina
United States	Loyola University Chicago	Chicago	Illinois
United States	Northwestern Memorial Hospital	Chicago	Illinois
United States	University Hospital Cleveland	Cleveland	Ohio
United States	University of Missouri	Columbia	Missouri
United States	Geisinger Medical Center	Danville	Pennsylvania
United States	Swedish - HCA	Englewood	Colorado
United States	Valley Baptist Medical Center	Harlingen	Texas
United States	University of Mississippi	Jackson	Mississippi
United States	University of Kentucky	Lexington	Kentucky
United States	UCLA	Los Angeles	California
United States	University of Louisville	Louisville	Kentucky
United States	Northwell Health	Manhasset	New York
United States	Methodist University Hospital	Memphis	Tennessee
United States	Mission Hospital	Mission Viejo	California
United States	Yale University	New Haven	Connecticut
United States	Ochsner Medical Center	New Orleans	Louisiana
United States	Mount Sinai	New York	New York
United States	Christiana Health	Newark	Delaware
United States	Abrazo Central	Phoenix	Arizona
United States	Harborview Medical Center	Seattle	Washington
United States	Virginia Mason Medical Center	Seattle	Washington
United States	Stony Brook University	Stony Brook	New York
United States	Atlantic Neuroscience Institute	Summit	New Jersey
United States	George Washington	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Penumbra Inc.

Countries where clinical trial is conducted

United States,  Austria,  Canada,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Global disability (functional outcome) assessed via the ordinal modified Rankin score (mRS)	(0 no symptoms - 5 severe disability)	180 days
Primary	Rate of mortality		30 days
Secondary	Functional outcomes measured via weighted modified Rankin Score (mRS)	(0 no symptoms - 5 severe disability)	180 days
Secondary	Functional outcomes measured via modified Rankin Score (mRS)	(0 no symptoms - 5 severe disability)	365 days
Secondary	Quality of life assessed via Stroke Impact Scale	Measures mobility and activities of daily living	180 and 365 days
Secondary	Quality of life assessed via EQ-5D-5L	Self assessment on activities of daily living	180 and 365 days
Secondary	Length of hospital stay		Admission to hospital discharge (up to one year)
Secondary	Length of ICU		# of days from admission (up to one year)
Secondary	Length of procedure		Time in minutes at the time of surgery (up to one day)
Secondary	Functional outcomes measured via modified Rankin Score (mRS) of = 3	(0 no symptoms - 5 severe disability)	180 days
Secondary	Functional outcomes measured via modified Rankin Score (mRS) of = 2	(0 no symptoms - 5 severe disability)	180 days