Millipede AspiRation for Revascularization in Stroke (MARRS) Study

NCT05714501 | Completed Results DMC FDA Device

• 1 other identifier: CLIN040
• Study Type: interventional
• Target: 235
• Locations: 3 countries
• Sites: 23

Brief Summary

The objectives of the study are to examine the performance and safety characteristics of the Millipede System when used for revascularization of patients with acute ischemic stroke due to Large Vessel Occlusions (LVOs) and to record associated clinical outcomes.

Conditions

Acute Ischemic Stroke

Outcome Measures

Primary Outcomes (6)

• ITT Cohort: Rate of Core Lab-adjudicated Reperfusion Success Within Three Passes

  Proportion of subjects with successful reperfusion, defined as achieving a modified Thrombolysis in Cerebrovascular Infarction (mTICI) score of 2b or greater within ≤3 passes with the Millipede System without additional therapy. The mTICI scale ranges from 0 to 3, with higher scores indicating better reperfusion: 0 = no perfusion, 1 = minimal perfusion, 2a = partial (\<50%), 2b = substantial (≥50%), 2c = near complete, 3 = complete. This measure reports the number of participants who achieved mTICI ≥2b under these criteria as adjudicated by an independent Core Lab.

  Intraprocedural

• ITT Cohort: Primary Safety Outcome

  All AEs will be analyzed, with specific attention to the rate of all intracranial hemorrhage (ICH), including symptomatic intracranial hemorrhage (sICH), subarachnoid hemorrhage (SAH), non-hemorrhagic AEs capable of producing neurological deterioration, and death.

  From Day 0 (procedure) through to the 90 Day visit.

• ITT Cohort: Supplementary Analysis of Primary Effectiveness Endpoint

  Proportion of subjects with successful reperfusion, defined as achieving a modified Thrombolysis in Cerebrovascular Infarction (mTICI) score of 2b or greater within 3 passes of Millipede System without additional therapy, and where use of any additional therapy after achieving mTICI ≥b with the Millipede System is defined as failure. The mTICI scale ranges from 0 to 3, with higher scores indicating better reperfusion: 0 = no perfusion, 1 = minimal perfusion, 2a = partial (\<50%), 2b = substantial (≥50%), 2c = near complete, 3 = complete. This measure reports the number of participants who achieved mTICI ≥2b under these criteria as adjudicated by an independent core lab.

  Intraprocedural

• PP Cohort: Rate of Core Lab-adjudicated Reperfusion Success Within Three Passes

  Proportion of subjects with successful reperfusion, defined as achieving a modified Thrombolysis in Cerebrovascular Infarction (mTICI) score of 2b or greater within ≤3 passes with the Millipede System without additional therapy. The mTICI scale ranges from 0 to 3, with higher scores indicating better reperfusion: 0 = no perfusion, 1 = minimal perfusion, 2a = partial (\<50%), 2b = substantial (≥50%), 2c = near complete, 3 = complete. This measure reports the number of participants who achieved mTICI ≥2b under these criteria as adjudicated by an independent Core Lab.

  Intraprocedural

• PP Cohort: Primary Safety Outcome

  All AEs will be analyzed, with specific attention to the rate of all intracranial hemorrhage (ICH), including symptomatic intracranial hemorrhage (sICH), subarachnoid hemorrhage (SAH), non-hemorrhagic AEs capable of producing neurological deterioration, and death.

  From Day 0 (procedure) through to the 90 Day visit.

• PP Cohort: Supplementary Analysis of Primary Effectiveness Endpoint

  Proportion of subjects with successful reperfusion, defined as achieving a modified Thrombolysis in Cerebrovascular Infarction (mTICI) score of 2b or greater within 3 passes of Millipede System without additional therapy, and where use of any additional therapy after achieving mTICI ≥b with the Millipede System is defined as failure. The mTICI scale ranges from 0 to 3, with higher scores indicating better reperfusion: 0 = no perfusion, 1 = minimal perfusion, 2a = partial (\<50%), 2b = substantial (≥50%), 2c = near complete, 3 = complete. This measure reports the number of participants who achieved mTICI ≥2b under these criteria as adjudicated by an independent core lab.

  Intraprocedural

Secondary Outcomes (20)

• ITT Cohort: Rate of Functional Independence

  90 days post-procedure

• ITT Cohort: Rate of All-Cause Mortality

  90 days post-procedure

• ITT Cohort: Rate of Symptomatic Intracranial Hemorrhage (sICH)

  24-hours post-procedure

• ITT Cohort: Rate of All Intracranial Hemorrhage (ICH)

  24 hours post-procedure

• ITT Cohort: Rate of Serious Adverse Device Effects (SADEs)

  90 days post-procedure

Other Outcomes (8)

• ITT Cohort: Proportion of Subjects With Successful Reperfusion After the First Pass With the Millipede 088 Catheter

  Intraprocedural

• ITT Cohort: Proportion of Subjects With Near Complete or Complete Reperfusion After the First Pass With the Millipede 088 Catheter

  Intraprocedural

• ITT Cohort: Proportion of Subjects With M1 Occlusions Achieving Successful Reperfusion After the First Pass With the Millipede 088 Catheter

  Intraprocedural

Study Arms (1)

Single Arm

EXPERIMENTAL

Millipede System

Device: Millipede System

Interventions

Millipede System DEVICE

Mechanical thrombectomy

Single Arm

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects aged ≥ 18 and ≤ 85 years.
• Pre-stroke mRS score of ≤ 1.
• Baseline NIHSS score of ≥ 6.
• A new focal disabling neurologic deficit consistent with acute cerebral ischemia.
• Evidence of a large vessel occlusion 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 on magnetic resonance angiography (MRA) or computed tomography angiography (CTA).
• Subject belongs to one of the following subgroups:
• Subject is ineligible for thrombolytic therapy, OR
• Subject is eligible for thrombolytic therapy and thrombolytic therapy was administered without delay and per current practice guidelines.
• 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).
• For strokes in the posterior circulation, the following imaging criterion should be met: pcASPECTS score 8 to 10 on baseline CT, CTA-source images, or Diffusion- Weighted Imaging (DWI) MRI.
• The interventionalist estimates that arterial puncture can be completed within 8 hours of onset/last known well.
• Informed consent obtained in accordance with the applicable country-specific regulations and as approved by the IRB/ REC.
• 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.

You may not qualify if:

• Known previous stroke within the past 3 months.
• Females who are known to be pregnant or breastfeeding.
• In the Investigator's opinion, any known comorbidity (including COVID-19) that may complicate treatment or prevent improvement or follow-up.
• Subject currently participating in or has previously participated in another trial involving an investigational device or drug within 30 days of enrollment.
• Known history of severe contrast allergy.
• Pre-existing neurological or psychiatric disease that would confound the neurological or functional evaluation.
• Life expectancy of less than 6 months prior to stroke onset.
• Known cocaine use at time of treatment.
• Known history of coagulation factor deficiency or oral anti-coagulant therapy with an International Normalized Ratio (INR) of more than 3.0.
• 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 treatment with a direct thrombin inhibitor within 48 hours with a PTT more than 1.5 times the laboratory normal.
• Known glucose level\< 50 mg/dl (2.78 mmol/L) or \> 400 mg/dl (22.20 mmol/L).
• Known platelet count \<50,000/µL.
• Clinical history, past imaging or clinical judgement suggest that the intracranial occlusion is chronic.
• For all patients, severe sustained hypertension with SBP \>220 mmHg and/or DBP \>120 mmHg; for patients treated with thrombolytic therapy, sustained hypertension despite treatment with SBP \>185 mmHg and/or DBP \> 110 mmHg.

Sponsors & Collaborators

• Perfuze: lead

Study Sites (23)

Yale University Hospital

New Haven, Connecticut, 06510, United States

Location

Baptist Health Research Institute

Jacksonville, Florida, 32207, United States

Location

Tampa General Hosital

Tampa, Florida, 33612, United States

Location

Emory

Atlanta, Georgia, 30322, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

University Of Rochester Medical Center (URMC)

Rochester, New York, 14620, United States

Location

Stony Brook University Hospital

Stony Brook, New York, 11794, United States

Location

ProMedica Toledo Hospital

Toledo, Ohio, 43606, United States

Location

Mercy Health

Toledo, Ohio, 43608, United States

Location

University of Toledo

Toledo, Ohio, 43614, United States

Location

Oregon Health & Science University (OHSU)

Portland, Oregon, 97239, United States

Location

University of Pittsburgh Medical Center (UPMC)

Pittsburgh, Pennsylvania, 15213, United States

Location

Semmes Murphey Foundation

Memphis, Tennessee, 38120, United States

Location

Valley Baptist Medical Center

Harlingen, Texas, 78550, United States

Location

UT Houston

Houston, Texas, 77225, United States

Location

CHU Bordeaux

Bordeaux, 33076, France

Location

CHU Montpellier

Montpellier, France

Location

CHRU de Nancy

Nancy, France

Location

CHU de Nantes - HGRL

Nantes, 44093, France

Location

CHRU Strasbourg

Strasbourg, 67200, France

Location

Toulouse University Hospital -CHU Purpan

Toulouse, France

Location

Vall d'Hebron

Barcelona, Spain

Location

Hospital Universitario La Paz

Madrid, 28046, Spain

Location

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Anne-Marie Gannon
• Organization: Perfuze

annemarie@perfuze.com

+35391428083

Study Officials

• Raul Nogueira, MD

  University of Pittsburgh Medical Center (UPMC), Pittsburgh, USA

  PRINCIPAL INVESTIGATOR

• Marc Ribo, MD

  Vall D'Hebron Hospital, Barcelona, Spain

  PRINCIPAL INVESTIGATOR

• Ricardo Hanel, MD

  Baptist Health Research Institute, Jacksonville, USA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2023
• First Posted: February 6, 2023
• Study Start: October 9, 2023
• Primary Completion: March 8, 2025
• Study Completion: May 12, 2025
• Last Updated: July 10, 2026
• Results First Posted: July 10, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (6); ES (2); US (15)