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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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up admission to hospital discharge (up to one year)
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
My blood pressure has been under 180 mmHg for at least 6 hours.
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My brain bleed is between 20 and 80 cc in size.
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I am between 18 and 80 years old.
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My treatment started within 3 days after my bleeding began.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ admission to hospital discharge (up to one year)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~admission to hospital discharge (up to one year)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Global disability (functional outcome) assessed via the ordinal modified Rankin score (mRS)
Rate of mortality
Secondary outcome measures
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
+6 moreTrial 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
35 Previous Clinical Trials
8,610 Total Patients Enrolled
14 Trials studying Stroke
3,457 Patients Enrolled for Stroke
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your Glasgow Coma Scale score is between 5 and 15.My blood pressure has been under 180 mmHg for at least 6 hours.There is bleeding in the lower part of the brain on imaging.The midbrain shows signs of being affected in imaging tests.You cannot have certain imaging tests because it could be harmful for you.I do not have a severe infection needing treatment right now.I have a known bleeding disorder.Your blood clotting time and certain blood tests are abnormal and cannot be fixed.My brain bleed is between 20 and 80 cc in size.A scan shows signs of a growing bleed in an artery.I have a bleeding lesion in my brain, like a malformation or tumor.You have a stroke with bleeding in the brain.I need urgent surgery to relieve pressure inside my skull or have uncontrolled pressure despite having a drain.I am not pregnant and have a negative pregnancy test.I have kidney failure or am on dialysis.You have a National Institutes of Health Stroke Scale (NIHSS) score of 6 or higher.I haven't taken blood thinners like apixaban or rivaroxaban in the last 2 days.I have a high-risk heart condition or symptoms related to narrowed neck arteries.I am between 18 and 80 years old.You have experienced traumatic bleeding in your brain.You have bleeding in the middle part of your brain called the thalamus.You need to have no signs of bleeding in an artery, and may need to have additional scans to confirm this.Your blood has low platelet count or does not work normally.My treatment started within 3 days after my bleeding began.Your symptoms started less than 24 hours before your first CT or MRI scan.You have a historical mRS score of 0 or 1.I need long-term blood thinners due to a mechanical heart valve or severe atrial fibrillation.I need treatment for bleeding inside my brain causing pressure or shift.
Research Study Groups:
This trial has the following groups:- Group 1: Artemis + Medical Management (MIS)
- Group 2: Best Medical Management Alone (MM)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Could potential participants join this experiment presently?
"Affirmative. The information on clinicaltrials.gov suggests that this experiment is currently recruiting patients, having been first published on February 7th 2018 and last revised October 21st 2022. 500 individuals will be recruited from 24 different medical sites."
Answered by AI
Does your research include individuals aged 55 and above?
"Eligibility criteria for this trial involves participants that are over the age of majority and below 80 years old."
Answered by AI
How many healthcare providers are currently administering this trial within the state?
"Currently, this trial is operating at 24 different clinical centres across America; these include New Orleans, Chicago and Summit. Thus, it might be wise to select the closest centre in order to reduce travel time if you decide to join the study."
Answered by AI
What is the current enrollment of participants in this trial?
"This clinical trial requires 500 patients to meet its enrollment quota, all of whom must adhere to the established inclusion criteria. Those hoping to participate can find locations at Ochsner Medical Center in New Orleans and Loyola University Chicago in Illinois."
Answered by AI
Are there any particular characteristics desirable for participants of this trial?
"This clinical trial seeks 500 individuals aged 18-80 with cerebral parenchymal haemorrhage. Necessary criteria include: a Glasgow Coma Scale (GCS) score between 5 and 15, historical modified Rankin Scale of 0 or 1, an intracerebral hematoma volume over 20 cc up to 80 cc as measured by the ellipsoid formula, signs/symptoms appearing no more than 24 hours before imaging study completion and medical intervention starting within 72 hours of ictus/bleed."
Answered by AI
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