← Back to Search

Thrombectomy Device

Millipede System for Ischemic Stroke (MARRS Trial)

N/A
Recruiting
Led By Raul Nogueira, MD
Research Sponsored by Perfuze
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Angiographic confirmation of a single large vessel occlusion (mTICI of 0-1) of the intracranial ICA (including T or L occlusions), the M1 or M2 segments of the MCA, the intracranial vertebral artery, or the basilar artery that is accessible to the Millipede System
For strokes in the anterior circulation, the following imaging criteria should be met: Magnetic Resonance Imaging (MRI) criterion: volume of diffusion restriction visually assessed as ≤ 50 mL, or Alberta Stroke Program Early CT Score (ASPECTS) 6-10; OR Computed Tomography (CT) criterion: Alberta Stroke Program Early CT Score (ASPECTS) 6-10 on baseline CT or Computed Tomography Angiography (CTA)- source images, or volume of significantly lowered relative Cerebral Blood Flow (rCBF) <30% (volume of ≤ 50 mL if CT perfusion is performed)
Must not have
Known history of treatment with heparin within 48 hours with a Partial Thromboplastin Time (PTT) more than two times the laboratory normal
Known history of cerebral vasculitis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 24 hours post-procedure.
Awards & highlights

Summary

This trial looks at safety & effectiveness of a device to treat stroke due to blocked arteries & associated patient outcomes.

Who is the study for?
Adults aged 18-85 with a recent ischemic stroke due to a large vessel blockage in the brain, who can start treatment within 8 hours of symptom onset. They must have had good health before the stroke, be able to give informed consent, and not be pregnant or breastfeeding. People with severe allergies, recent strokes or surgeries, certain blood disorders, drug abuse, infections like septicemia (except common cold), life expectancy less than 6 months prior to stroke onset are excluded.Check my eligibility
What is being tested?
The Millipede System is being tested for its effectiveness and safety in reopening blocked vessels in the brain during an acute ischemic stroke. The study will record how well it works and track patients' recovery outcomes.See study design
What are the potential side effects?
While specific side effects are not listed here, similar procedures may include risks such as bleeding at the puncture site, allergic reactions to contrast dye used during imaging tests, infection risk from invasive procedures and potential damage to blood vessels.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have a confirmed blockage in a major brain artery that can be treated with the Millipede System.
Select...
My stroke imaging shows it's small or not severe based on specific MRI or CT scores.
Select...
I am between 18 and 85 years old.
Select...
I was mostly independent before my stroke.
Select...
I have recently experienced a stroke or stroke-like symptoms.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I've been treated with heparin recently and my blood clotting time is high.
Select...
I have been diagnosed with inflammation of blood vessels in my brain.
Select...
I've been treated with a blood thinner recently and my clotting test was high.
Select...
My brain scan shows significant pressure due to a tumor.
Select...
I have seizures caused by a stroke.
Select...
I have had a stroke in the last 3 months.
Select...
I was treated with a clot-busting drug or device through an artery before using the Millipede System.
Select...
My cancer has spread to other parts of my body.
Select...
I have an aneurysm in the area planned for treatment.
Select...
I am currently pregnant or breastfeeding.
Select...
I have a bleeding or clotting disorder.
Select...
I don't have severe artery blockages that would interfere with the study treatment.
Select...
I do not have any mental or nerve conditions that could affect my study results.
Select...
My kidney function is severely impaired.
Select...
I have had strokes affecting both sides of my brain or multiple areas.
Select...
I have a blood clotting issue or take blood thinners with an INR over 3.0.
Select...
I have severe high blood pressure not controlled by medication.
Select...
I might have a heart infection or a tear in my heart's main artery.

Timeline

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Occurrence of symptomatic intracerebral hemorrhage (sICH) within 24 (-8/+24) hours post-procedure.
Proportion of subjects with successful reperfusion, defined as achieving a modified Thrombolysis in Cerebrovascular Infarction (mTICI) score of 2b or greater, after ≤3 passes with the Millipede System without additional therapy.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Single ArmExperimental Treatment1 Intervention
Millipede System

Find a Location

Who is running the clinical trial?

PerfuzeLead Sponsor
Raul Nogueira, MDPrincipal InvestigatorUniversity of Pittsburgh Medical Center (UPMC), Pittsburgh, USA
3 Previous Clinical Trials
2,427 Total Patients Enrolled
3 Trials studying Stroke
2,427 Patients Enrolled for Stroke
Ricardo Hanel, MDPrincipal InvestigatorBaptist Health Research Institute, Jacksonville, USA
~129 spots leftby Jul 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