← Back to Search

Device

Minimally Invasive Surgery for Stroke

N/A
Waitlist Available
Research Sponsored by Penumbra Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
SBP must be < 180 mmHg and controlled at this level for at least 6 hours
Supratentorial ICH of volume ≥ 20 and ≤ 80 cc (measured using A x B X C/2 method)
Must not have
Patient Factors: Severe active infection requiring treatment (e.g. sepsis or purulent wound) at the time of enrollment
Coagulation Issues: Known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 180 and 365 days
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing whether a minimally invasive device is better than best medical management at treating intracerebral hemorrhage.

Who is the study for?
This trial is for adults aged 18-80 with a recent stroke causing bleeding in the brain (20-80 cc volume). They must have moderate to severe symptoms, be stable, and able to start treatment within 72 hours of the stroke. Excluded are those with certain types of hemorrhages, ongoing serious infections, severe kidney issues, pregnancy, or conditions affecting survival or follow-up.
What is being tested?
The MIND trial is testing if using Artemis Neuro Evacuation Device plus standard medical care is safer and more effective than just standard care alone for removing blood from the brain after a hemorrhage caused by a stroke.
What are the potential side effects?
Potential side effects may include risks associated with minimally invasive surgery such as infection, bleeding at the site of evacuation, possible neurological deterioration due to procedure-related complications or reactions to anesthesia.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My blood pressure has been under 180 mmHg for at least 6 hours.
Select...
My brain bleed is between 20 and 80 cc in size.
Select...
I am between 18 and 80 years old.
Select...
My treatment started within 3 days after my bleeding began.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I do not have a severe infection needing treatment right now.
Select...
I have a known bleeding disorder.
Select...
I have a bleeding lesion in my brain, like a malformation or tumor.
Select...
I need urgent surgery to relieve pressure inside my skull or have uncontrolled pressure despite having a drain.
Select...
I am not pregnant and have a negative pregnancy test.
Select...
I have kidney failure or am on dialysis.
Select...
I have a high-risk heart condition or symptoms related to narrowed neck arteries.
Select...
I need long-term blood thinners due to a mechanical heart valve or severe atrial fibrillation.
Select...
I need treatment for bleeding inside my brain causing pressure or shift.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~180 and 365 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 180 and 365 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Global disability (functional outcome) assessed via the ordinal modified Rankin score (mRS)
Secondary study objectives
Functional outcomes measured via modified Rankin Score (mRS)
Functional outcomes measured via modified Rankin Score (mRS) of ≤ 2
Functional outcomes measured via modified Rankin Score (mRS) of ≤ 3
+3 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Artemis + Medical Management (MIS)Experimental Treatment1 Intervention
Minimally invasive hematoma evacuation with the Artemis Neuro Evacuation Device with medical management
Group II: Best Medical Management Alone (MM)Active Control1 Intervention
Best medical management alone per standard of care at treating institution

Find a Location

Who is running the clinical trial?

Penumbra Inc.Lead Sponsor
36 Previous Clinical Trials
9,951 Total Patients Enrolled

Media Library

Artemis Neuro Evacuation Device (Device) Clinical Trial Eligibility Overview. Trial Name: NCT03342664 — N/A
Intracerebral Hemorrhage Research Study Groups: Artemis + Medical Management (MIS), Best Medical Management Alone (MM)
Intracerebral Hemorrhage Clinical Trial 2023: Artemis Neuro Evacuation Device Highlights & Side Effects. Trial Name: NCT03342664 — N/A
Artemis Neuro Evacuation Device (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03342664 — N/A
~64 spots leftby Dec 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top