Minimally Invasive Surgery for Stroke

Recruiting in Palo Alto (17 mi)

+32 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Penumbra Inc.

No Placebo Group

Trial Summary

What is the purpose of this trial?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).

Eligibility Criteria

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.

Inclusion Criteria

My blood pressure has been under 180 mmHg for at least 6 hours.

My brain bleed is between 20 and 80 cc in size.

I am between 18 and 80 years old.

My treatment started within 3 days after my bleeding began.

Exclusion Criteria

I do not have a severe infection needing treatment right now.

I have a known bleeding disorder.

I have a bleeding lesion in my brain, like a malformation or tumor.

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.

I have a high-risk heart condition or symptoms related to narrowed neck arteries.

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.

Participant Groups

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.

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