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Thrombectomy Device

Millipede System for Ischemic Stroke (MARRS Trial)

Q: Is the enrollment criteria of this experiment conducive to geriatric patients?

This medical trial is searching for participants aged over 18 and below 85 years old.

Q: Are new participants being accepted for enrollment in this trial?

Affirmative. According to the clinicaltrials.gov, this medical research was put up for public view on October 9th 2023 and has been recently revised on November 15th of the same year. It is presently searching for 225 volunteers that will be examined at 13 different clinical trial sites.

Q: Is there an opportunity to participate in this medical investigation?

In order to qualify, potential candidates must have experienced a <a href="https://www.withpower.com/clinical-trials/stroke">stroke</a> and should be between 18-85 years old. Currently, the trial is attempting to acquire 225 participants.

Q: Are there any Canadian centers hosting this medical investigation?

To date, 13 different medical centres are enrolled in the trial. These include <a href="https://www.withpower.com/clinical-trials/oregon">Oregon</a> Health &#x26; Science University (OHSU) in Portland, Hôpital Fondation Adolphe de Rothschild in Paris and Vall d'Hebron Hospital in Barcelona among other locations.

Q: How many participants are engaged in this medical experimentation?

To successfully execute this trial, 225 eligible patients will be needed. Perfuze is overseeing the recruiting process from two sites: OHSU in Portland, <a href="https://www.withpower.com/clinical-trials/oregon">Oregon</a> and Hôpital Fondation Adolphe de Rothschild in Paris, <a href="https://www.withpower.com/clinical-trials/connecticut">Connecticut</a>.

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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up within 24 hours post-procedure.

Awards & highlights

MARRS Trial 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.

MARRS Trial 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.

MARRS Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ during procedure.

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.

MARRS Trial Design

1Treatment groups

Experimental Treatment

Group I: Single ArmExperimental Treatment1 Intervention

Millipede System

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

PerfuzeLead Sponsor

Raul Nogueira, MDPrincipal InvestigatorUniversity of Pittsburgh Medical Center (UPMC), Pittsburgh, USA

2 Previous Clinical Trials

427 Total Patients Enrolled

2 Trials studying Stroke

427 Patients Enrolled for Stroke

Ameer Hassan, MDPrincipal InvestigatorValley Baptist Hospital, Texas

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the enrollment criteria of this experiment conducive to geriatric patients?

"This medical trial is searching for participants aged over 18 and below 85 years old."

Answered by AI

Are new participants being accepted for enrollment in this trial?

"Affirmative. According to the clinicaltrials.gov, this medical research was put up for public view on October 9th 2023 and has been recently revised on November 15th of the same year. It is presently searching for 225 volunteers that will be examined at 13 different clinical trial sites."

Answered by AI

Is there an opportunity to participate in this medical investigation?

"In order to qualify, potential candidates must have experienced a stroke and should be between 18-85 years old. Currently, the trial is attempting to acquire 225 participants."

Answered by AI

Are there any Canadian centers hosting this medical investigation?

"To date, 13 different medical centres are enrolled in the trial. These include Oregon Health & Science University (OHSU) in Portland, Hôpital Fondation Adolphe de Rothschild in Paris and Vall d'Hebron Hospital in Barcelona among other locations."

Answered by AI

How many participants are engaged in this medical experimentation?

"To successfully execute this trial, 225 eligible patients will be needed. Perfuze is overseeing the recruiting process from two sites: OHSU in Portland, Oregon and Hôpital Fondation Adolphe de Rothschild in Paris, Connecticut."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Millipede AspiRation for Revascularization in Stroke (MARRS) Study

2023. "Millipede AspiRation for Revascularization in Stroke (MARRS) Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05714501.