Millipede AspiRation for Revascularization in Stroke (MARRS) Study

Completed · Not applicable

Conditions studied: Acute Ischemic Stroke

In brief

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.

Key facts

Study ID: NCT05714501
Run by: Perfuze
People needed: 235
Starts: 2023-10-09
Expected to finish: 2025-05-12
Last updated by the study team: 2026-07-10

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

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.
Renal failure with serum creatinine ≥3 mg/dL or Glomerular Filtration Rate (GFR) <30 mL/min.
Ongoing seizure due to stroke.
Initially treated with intra-arterial thrombolytics or a different neurothrombectomy device before use of the Millipede System.
Clinical symptoms of bilateral stroke or stroke in multiple territories.
Known history of cerebral vasculitis.
Evidence of active systemic infection (e.g. septicemia). Exceptions: common cold, hepatitis B virus (HBV), hepatitis C virus (HCV).
Any known hemorrhagic or coagulation deficiency.
Evidence of current intracranial hemorrhage on imaging.
Significant mass effect with midline shift.
Known arterial condition in a proximal vessel that requires treatment or prevents access to the site of occlusion or safe recovery of the investigational device (for example, severe stenosis, complete occlusion in the cervical ICA, tandem occlusion).

Where it is running

Mercy Health — Toledo, Ohio, United States
Yale University Hospital — New Haven, Connecticut, United States
Baptist Health Research Institute — Jacksonville, Florida, United States
Tampa General Hosital — Tampa, Florida, United States
Emory — Atlanta, Georgia, United States
University of Chicago — Chicago, Illinois, United States
University Of Rochester Medical Center (URMC) — Rochester, New York, United States
Stony Brook University Hospital — Stony Brook, New York, United States
ProMedica Toledo Hospital — Toledo, Ohio, United States
University of Toledo — Toledo, Ohio, United States
Oregon Health & Science University (OHSU) — Portland, Oregon, United States
University of Pittsburgh Medical Center (UPMC) — Pittsburgh, Pennsylvania, United States
Semmes Murphey Foundation — Memphis, Tennessee, United States
Valley Baptist Medical Center — Harlingen, Texas, United States
UT Houston — Houston, Texas, United States
CHU Bordeaux — Bordeaux, France
CHU Montpellier — Montpellier, France
CHRU de Nancy — Nancy, France
CHU de Nantes - HGRL — Nantes, France
CHRU Strasbourg — Strasbourg, France
Toulouse University Hospital -CHU Purpan — Toulouse, France
Vall d'Hebron — Barcelona, Spain
Hospital Universitario La Paz — Madrid, Spain

Full record on ClinicalTrials.gov

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