Millipede AspiRation for Revascularization in Stroke (MARRS) Study (MARRS)

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.

Study Overview

• Status: Recruiting
• Conditions: Acute Ischemic Stroke
• Intervention / Treatment: Device: Millipede System

Detailed Description

Ischemic stroke is a life-threatening condition. Annually, approximately 795,000 people in the United States have a stroke.

The MARRS study is an interventional, open label, single arm, multi center, prospective clinical investigation. The objectives of the study are to evaluate the performance and safety characteristics of the Millipede System in patients presenting with acute ischemic stroke due to LVOs and to record clinical outcomes.

• Study Type: Interventional
• Enrollment (Estimated): 225
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hazel Kilkelly; Phone Number: +353-91428083; Email: hazel@perfuze.com
• Study Contact Backup: Name: Veronica Lewis; Phone Number: 19177484820; Email: Veronica@perfuze.com

Study Locations

• France
  • Bordeaux, France, 33076
    • Not yet recruiting
    • CHU Bordeaux
    • Contact: Gaultier Marnat
  • Montpellier, France
    • Not yet recruiting
    • Chu Montpellier
    • Contact: Gregory Gascou
  • Nancy, France
    • Recruiting
    • CHRU de Nancy
    • Contact: Benjamin Gory
  • Nantes, France, 44093
    • Not yet recruiting
    • CHU de Nantes - HGRL
    • Contact: Romain Bourcier
  • Paris, France
    • Not yet recruiting
    • Hopital Fondation Adolphe de Rothschild
    • Contact: Raphael Blanc
  • Strasbourg, France, 67200
    • Not yet recruiting
    • CHRU Strasbourg
    • Contact: Raoul Pop
  • Toulouse, France
    • Not yet recruiting
    • Toulouse University Hospital -CHU Purpan
    • Contact: Christophe Cognard
• Spain
  • Barcelona, Spain
    • Recruiting
    • Vall d'Hebron
    • Contact: Marc Ribo
  • Madrid, Spain, 28046
    • Recruiting
    • Hospital Universitario La Paz
    • Contact: Pedro Navia
• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Recruiting
      • Yale University Hospital
      • Contact: Charles Matouk
  • Florida
    • Tampa, Florida, United States, 33612
      • Not yet recruiting
      • Tampa General Hosital
      • Contact: Waldo Guerrero
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Not yet recruiting
      • Emory
      • Contact: Diogo . Haussen
  • New York
    • Rochester, New York, United States, 14620
      • Not yet recruiting
      • University of Rochester Medical Center (URMC)
      • Contact: Tarun Bhalla
    • Stony Brook, New York, United States, 11794
      • Recruiting
      • Stony Brook University Hospital
      • Contact: Reza Dashti
  • Oregon
    • Portland, Oregon, United States, 97239
      • Not yet recruiting
      • Oregon Health & Science University (OHSU)
      • Contact: Ryan Priest
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Not yet recruiting
      • Thomas Jefferson
      • Contact: Reid Gooch
    • Pittsburgh, Pennsylvania, United States, 15213
      • Recruiting
      • University of Pittsburgh Medical Center (UPMC)
      • Contact: Alhamza Al-Bayati
  • Tennessee
    • Memphis, Tennessee, United States, 38120
      • Not yet recruiting
      • Semmes Murphey Foundation
      • Contact: Nitin Goyal
  • Texas
    • Harlingen, Texas, United States, 78550
      • Recruiting
      • Valley Baptist Medical Center
      • Contact: Sohum Desai

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Subjects aged ≥ 18 and ≤ 85 years.
2. Pre-stroke mRS score of ≤ 1.
3. Baseline NIHSS score of ≥ 6.
4. A new focal disabling neurologic deficit consistent with acute cerebral ischemia.
5. 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).

6. Subject belongs to one of the following subgroups:

   1. Subject is ineligible for thrombolytic therapy, OR
   2. Subject is eligible for thrombolytic therapy and thrombolytic therapy was administered without delay and per current practice guidelines.

7. For strokes in the anterior circulation, the following imaging criteria should be met:

   1. 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
   2. 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).
8. 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.
9. The interventionalist estimates that arterial puncture can be completed within 8 hours of onset/last known well.
10. Informed consent obtained in accordance with the applicable country-specific regulations and as approved by the IRB/ REC.
11. 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.

Exclusion Criteria:

1. Known previous stroke within the past 3 months.
2. Females who are known to be pregnant or breastfeeding.
3. In the Investigator's opinion, any known comorbidity (including COVID-19) that may complicate treatment or prevent improvement or follow-up.
4. Subject currently participating in or has previously participated in another trial involving an investigational device or drug within 30 days of enrollment.
5. Known history of severe contrast allergy.
6. Pre-existing neurological or psychiatric disease that would confound the neurological or functional evaluation.
7. Life expectancy of less than 6 months prior to stroke onset.
8. Known cocaine use at time of treatment.
9. Known history of coagulation factor deficiency or oral anti-coagulant therapy with an International Normalized Ratio (INR) of more than 3.0.
10. Known history of treatment with heparin within 48 hours with a Partial Thromboplastin Time (PTT) more than two times the laboratory normal.
11. Known history of treatment with a direct thrombin inhibitor within 48 hours with a PTT more than 1.5 times the laboratory normal.
12. Known glucose level< 50 mg/dl (2.78 mmol/L) or > 400 mg/dl (22.20 mmol/L).
13. Known platelet count <50,000/µL.
14. Clinical history, past imaging or clinical judgement suggest that the intracranial occlusion is chronic.
15. 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.
16. Renal failure with serum creatinine ≥3 mg/dL or Glomerular Filtration Rate (GFR) <30 mL/min.
17. Ongoing seizure due to stroke.
18. Initially treated with intra-arterial thrombolytics or a different neurothrombectomy device before use of the Millipede System.
19. Clinical symptoms of bilateral stroke or stroke in multiple territories.
20. Known history of cerebral vasculitis.
21. Evidence of active systemic infection (e.g. septicemia). Exceptions: common cold, hepatitis B virus (HBV), hepatitis C virus (HCV).
22. Any known hemorrhagic or coagulation deficiency.
23. Evidence of current intracranial hemorrhage on imaging.
24. Significant mass effect with midline shift.
25. 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).
26. Suspicion or evidence of aortic dissection, septic embolus, or bacterial endocarditis.
27. Evidence of dissection in the extracranial or intracranial cerebral arteries.
28. Excessive arterial tortuosity that may preclude device placement as determined by CTA/Magnetic Resonance Angiography (MRA) and/or conventional angiography.
29. Evidence of multiple vascular occlusions (e.g., bilateral anterior circulation, anterior/posterior circulation, concurrent occlusions in the anterior cerebral artery (ACA) and MCA, other concurrent ipsilateral occlusions in the same or different territories).
30. CT or MRI showing mass effect or intracranial tumor (apart from small meningioma, ≤ 2 cm in diameter).
31. Known cancer with metastases.
32. Known aneurysm at or near the target treatment segment.
33. Angiographic evidence of known or suspected underlying intracranial vasculopathy or atherosclerotic lesions responsible for the target occlusion

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single Arm; Millipede System	Device: Millipede System; Mechanical thrombectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	mTICI of 2b or greater indicating successful reperfusion.	During procedure.
Occurrence of symptomatic intracerebral hemorrhage (sICH) within 24 (-8/+24) hours post-procedure.	Evaluation of sICH.	Within 24 hours post-procedure.

Collaborators and Investigators

• Sponsor: Perfuze
• Investigators: Principal Investigator: Raul Nogueira, MD, University of Pittsburgh Medical Center (UPMC), Pittsburgh, USA; Principal Investigator: Marc Ribo, MD, Vall D'Hebron Hospital, Barcelona, Spain

Study record dates

Study Major Dates

• Study Start (Actual): October 9, 2023
• Primary Completion (Estimated): July 31, 2025
• Study Completion (Estimated): October 31, 2025

Study Registration Dates

• First Submitted: January 26, 2023
• First Submitted That Met QC Criteria: January 26, 2023
• First Posted (Actual): February 6, 2023

Study Record Updates

• Last Update Posted (Estimated): March 6, 2024
• Last Update Submitted That Met QC Criteria: March 5, 2024
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Ischemic Stroke
• Other Study ID Numbers: CLIN040

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes