Acute Ischemic StrokeMARRSNCT05714501
Millipede AspiRation for Revascularization in Stroke (MARRS) Study
A study testing Millipede System in people with Acute Ischemic Stroke, run by Perfuze at 23 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- Millipede System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 235 participants
- Where
- 23 sitesin 3 countries
- Study dates
- 9 Oct 2023to 12 May 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
Show all 15Show fewer
- 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.
Who cannot join
- 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.
Show all 33Show fewer
- 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).
- Suspicion or evidence of aortic dissection, septic embolus, or bacterial endocarditis.
- Evidence of dissection in the extracranial or intracranial cerebral arteries.
- Excessive arterial tortuosity that may preclude device placement as determined by CTA/Magnetic Resonance Angiography (MRA) and/or conventional angiography.
- 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).
- CT or MRI showing mass effect or intracranial tumor (apart from small meningioma, ≤ 2 cm in diameter).
- Known cancer with metastases.
- Known aneurysm at or near the target treatment segment.
- Angiographic evidence of known or suspected underlying intracranial vasculopathy or atherosclerotic lesions responsible for the target occlusion
Trial locations and contacts
23 sites in 3 countries.
23 sites in 3 countries
United States15 sites
Emory
Atlanta, Georgia, 30322
University of Chicago
Chicago, Illinois, 60637
Valley Baptist Medical Center
Harlingen, Texas, 78550
UT Houston
Houston, Texas, 77225
Baptist Health Research Institute
Jacksonville, Florida, 32207
Semmes Murphey Foundation
Memphis, Tennessee, 38120
Yale University Hospital
New Haven, Connecticut, 06510
University of Pittsburgh Medical Center (UPMC)
Pittsburgh, Pennsylvania, 15213
Oregon Health & Science University (OHSU)
Portland, Oregon, 97239
University Of Rochester Medical Center (URMC)
Rochester, New York, 14620
Stony Brook University Hospital
Stony Brook, New York, 11794
Tampa General Hosital
Tampa, Florida, 33612
ProMedica Toledo Hospital
Toledo, Ohio, 43606
Mercy Health
Toledo, Ohio, 43608
University of Toledo
Toledo, Ohio, 43614
France6 sites
CHU Bordeaux
Bordeaux, 33076
CHU Montpellier
Montpellier
CHRU de Nancy
Nancy
CHU de Nantes - HGRL
Nantes, 44093
CHRU Strasbourg
Strasbourg, 67200
Toulouse University Hospital -CHU Purpan
Toulouse
About this study
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.
Read the 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.
- Conditions
- Acute Ischemic Stroke
- Being tested
- Millipede System
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Millipede SystemDevice
Mechanical thrombectomy
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Experimental | Millipede System Receives: Device: Millipede System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Intraprocedural
Secondary outcomes (20)
ITT Cohort: Rate of Functional Independence
The proportion of patients achieving modified Rankin Scale (mRS) score ≤2, evaluated by certified assessors.
The mRS scale ranges from 0 (no symptoms) to 5 (severe disability), with an additional category of 6 for death.
Measured: 90 days post-procedure
ITT Cohort: Rate of All-Cause Mortality
Proportion of subjects that died within 90 days of the procedure
Measured: 90 days post-procedure
ITT Cohort: Rate of Symptomatic Intracranial Hemorrhage (sICH)
Rate of symptomatic intracranial hemorrhage (sICH), as independently adjudicated by the Core Lab and Clinical Events Committee
Measured: 24-hours post-procedure
ITT Cohort: Rate of All Intracranial Hemorrhage (ICH)
Proportion of subjects with any ICH at 24 hours, as adjudicated by the Core Lab
Measured: 24 hours post-procedure
ITT Cohort: Rate of Serious Adverse Device Effects (SADEs)
Proportion of subjects experiencing one or more SADEs within 90 days post-procedure, as adjudicated by an independent Clinical Events Committee
Measured: 90 days post-procedure
ITT Cohort: Rate of Procedure-Related Serious Adverse Events (PRSAEs)
Proportion of subjects experiencing one or more procedure-related serious adverse events within 90 days post-procedure, as adjudicated by an independent Clinical Events Committee
Measured: 90 days post-procedure
ITT Cohort: Rate of Embolization to New Territory (ENT)
Proportion of subjects with distal emboli on final angiography, as adjudicated by an independent Core Lab
Measured: Intraprocedural
ITT Cohort: Proportion of Subjects With Successful Reperfusion at End of the Thrombectomy Procedure
Proportion of subjects with mTICI ≥2b at the end of the procedure. 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 at the end of the procedure, as adjudicated by an independent Core Lab.
Measured: Intraprocedural
ITT Cohort: Proportion of Subjects With Complete or Near Complete Reperfusion at End of the Thrombectomy Procedure
Proportion of subjects with mTICI ≥2c at the end of the procedure. 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 ≥2c at the end of the procedure, as adjudicated by an independent Core Lab.
Measured: Intraprocedural
ITT Cohort: Proportion of Subjects With Successful Reperfusion After the First Pass With the Millipede System
Proportion of subjects with mTICI ≥2b after the first pass with the Millipede System. 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 after the first pass with the Millipede System, as adjudicated by an independent Core Lab.
Measured: Intraprocedural
ITT Cohort: Proportion of Subjects With Complete or Near Complete Reperfusion at the End of the First Pass With the Millipede System
Proportion of subjects with mTICI ≥2c after the first pass with the Millipede System. 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 ≥2c after the first pass with the Millipede System, as adjudicated by an independent Core Lab.
Measured: Intraprocedural
PP Cohort: Rate of Functional Independence
The proportion of patients achieving modified Rankin Scale (mRS) score ≤2, evaluated by certified assessors.
The mRS scale ranges from 0 (no symptoms) to 5 (severe disability), with an additional category of 6 for death.
Measured: 90 days post-procedure
PP Cohort: Rate of All-Cause Mortality
Proportion of subjects that died within 90 days of the procedure
Measured: 90 days post-procedure
PP Cohort: Rate of Symptomatic Intracranial Hemorrhage (sICH)
Rate of symptomatic intracranial hemorrhage (sICH), as independently adjudicated by the Core Lab and Clinical Events Committee
Measured: 24-hours post-procedure
PP Cohort: Rate of All Intracranial Hemorrhage (ICH)
Proportion of subjects with any ICH at 24 hours, as adjudicated by the Core Lab
Measured: 24 hours post-procedure
PP Cohort: Rate of Embolization to New Territory (ENT)
Proportion of subjects with distal emboli on final angiography, as adjudicated by an independent Core Lab
Measured: Intraprocedural
PP Cohort: Proportion of Subjects With Successful Reperfusion at End of the Thrombectomy Procedure
Proportion of subjects with mTICI ≥2b at the end of the procedure. 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 at the end of the procedure, as adjudicated by an independent Core Lab.
Measured: Intraprocedural
PP Cohort: Proportion of Subjects With Complete or Near Complete Reperfusion at End of the Thrombectomy Procedure
Proportion of subjects with mTICI ≥2c at the end of the procedure. 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 ≥2c at the end of the procedure, as adjudicated by an independent Core Lab.
Measured: Intraprocedural
PP Cohort: Proportion of Subjects With Successful Reperfusion After the First Pass With the Millipede System
Proportion of subjects with mTICI ≥2b after the first pass with the Millipede System. 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 after the first pass with the Millipede System, as adjudicated by an independent Core Lab.
Measured: Intraprocedural
PP Cohort: Proportion of Subjects With Complete or Near Complete Reperfusion at the End of the First Pass With the Millipede System
Proportion of subjects with mTICI ≥2c after the first pass with the Millipede System. 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 ≥2c after the first pass with the Millipede System, as adjudicated by an independent Core Lab.
Measured: Intraprocedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2023
- Study start9 Oct 2023
- Primary completion8 Mar 2025
- Study completion12 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 235 participants (actual)
Sponsor and investigators
- Lead sponsor
- Perfuze
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Raul Nogueira, MD, Principal investigator, University of Pittsburgh Medical Center (UPMC), Pittsburgh, USAMarc Ribo, MD, Principal investigator, Vall D'Hebron Hospital, Barcelona, SpainRicardo Hanel, MD, Principal investigator, Baptist Health Research Institute, Jacksonville, USA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05714501
- Sponsor's protocol ID
- CLIN040
- Acronym
- MARRS
- Status last verified
- Jun 2026
- First submitted
- 26 Jan 2023
- Last updated
- 10 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Nogueira RG, Requena M, Dolia J, Zaidi S, Navia P, Marnat G, Bhalla T, Al-Bayati AR, Nahhas M, Zaidat OO, Priest R, Bourcier R, Guerrero WR, Dashti R, Gascou G, Pop R, Kass-Hout T, Goyal N, Aghaebrahim A, Qureshi AI, Ansari SA, Dabus G, Suarez JI, Makalanda LD, Alvarez-Muelas A, Barreau X, Bender MT, Jumaa M, Lin E, Bellanger G, Diana F, Hebert R, Sheth SA, Burgess R, Haussen DC, Matouk C, Cognard C, Hassan AE, Hanel RA, Gory B, Ribo M. Millipede Aspiration for Revascularization in Stroke (MARRS): prospective trial of a novel 0.088 inch corrugated catheter. J Neurointerv Surg. 2026 Aug 27:jnis-2026-025573. doi: 10.1136/jnis-2026-025573. Online ahead of print.
PubMed 42660659
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Millipede AspiRation for Revascularization in Stroke (MARRS) Study
- ClinicalTrials.gov ID
- NCT05714501
- Acronym / sponsor ID
- MARRS / CLIN040
- Conditions
- Acute Ischemic Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 235 participants (actual)
- Lead sponsor
- PerfuzeIndustry (pharma, biotech, devices)
- Study start
- 9 Oct 2023 (actual)
- Primary completion
- 8 Mar 2025 (actual)
- Study completion
- 12 May 2025 (actual)
- First posted
- 6 Feb 2023 (actual)
- Results
- Posted 10 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Experimental | Device: Millipede SystemMillipede System |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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).
Key exclusion criteria (33 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Millipede SystemMechanical thrombectomy | Device | Single Arm |
Primary outcome
ITT Cohort: Rate of Core Lab-adjudicated Reperfusion Success Within Three Passes
Time frame: Intraprocedural
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.
ITT Cohort: Primary Safety Outcome
Time frame: From Day 0 (procedure) through to the 90 Day visit.
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.
ITT Cohort: Supplementary Analysis of Primary Effectiveness Endpoint
Time frame: Intraprocedural
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.
PP Cohort: Rate of Core Lab-adjudicated Reperfusion Success Within Three Passes
Time frame: Intraprocedural
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.
PP Cohort: Primary Safety Outcome
Time frame: From Day 0 (procedure) through to the 90 Day visit.
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.
PP Cohort: Supplementary Analysis of Primary Effectiveness Endpoint
Time frame: Intraprocedural
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.
20 secondary outcomes
ITT Cohort: Rate of Functional Independence
Time frame: 90 days post-procedure
ITT Cohort: Rate of All-Cause Mortality
Time frame: 90 days post-procedure
ITT Cohort: Rate of Symptomatic Intracranial Hemorrhage (sICH)
Time frame: 24-hours post-procedure
ITT Cohort: Rate of All Intracranial Hemorrhage (ICH)
Time frame: 24 hours post-procedure
ITT Cohort: Rate of Serious Adverse Device Effects (SADEs)
Time frame: 90 days post-procedure
ITT Cohort: Rate of Procedure-Related Serious Adverse Events (PRSAEs)
Time frame: 90 days post-procedure
ITT Cohort: Rate of Embolization to New Territory (ENT)
Time frame: Intraprocedural
ITT Cohort: Proportion of Subjects With Successful Reperfusion at End of the Thrombectomy Procedure
Time frame: Intraprocedural
ITT Cohort: Proportion of Subjects With Complete or Near Complete Reperfusion at End of the Thrombectomy Procedure
Time frame: Intraprocedural
ITT Cohort: Proportion of Subjects With Successful Reperfusion After the First Pass With the Millipede System
Time frame: Intraprocedural
ITT Cohort: Proportion of Subjects With Complete or Near Complete Reperfusion at the End of the First Pass With the Millipede System
Time frame: Intraprocedural
PP Cohort: Rate of Functional Independence
Time frame: 90 days post-procedure
PP Cohort: Rate of All-Cause Mortality
Time frame: 90 days post-procedure
PP Cohort: Rate of Symptomatic Intracranial Hemorrhage (sICH)
Time frame: 24-hours post-procedure
PP Cohort: Rate of All Intracranial Hemorrhage (ICH)
Time frame: 24 hours post-procedure
PP Cohort: Rate of Embolization to New Territory (ENT)
Time frame: Intraprocedural
PP Cohort: Proportion of Subjects With Successful Reperfusion at End of the Thrombectomy Procedure
Time frame: Intraprocedural
PP Cohort: Proportion of Subjects With Complete or Near Complete Reperfusion at End of the Thrombectomy Procedure
Time frame: Intraprocedural
PP Cohort: Proportion of Subjects With Successful Reperfusion After the First Pass With the Millipede System
Time frame: Intraprocedural
PP Cohort: Proportion of Subjects With Complete or Near Complete Reperfusion at the End of the First Pass With the Millipede System
Time frame: Intraprocedural
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42660659Nogueira RG, Requena M, Dolia J, Zaidi S, Navia P, Marnat G, Bhalla T, Al-Bayati AR, Nahhas M, Zaidat OO, Priest R, Bourcier R, Guerrero WR, Dashti R, Gascou G, Pop R, Kass-Hout T, Goyal N, Aghaebrahim A, Qureshi AI, Ansari SA, Dabus G, Suarez JI, Makalanda LD, Alvarez-Muelas A, Barreau X, Bender MT, Jumaa M, Lin E, Bellanger G, Diana F, Hebert R, Sheth SA, Burgess R, Haussen DC, Matouk C, Cognard C, Hassan AE, Hanel RA, Gory B, Ribo M. Millipede Aspiration for Revascularization in Stroke (MARRS): prospective trial of a novel 0.088 inch corrugated catheter. J Neurointerv Surg. 2026 Aug 27:jnis-2026-025573. doi: 10.1136/jnis-2026-025573. Online ahead of print.
- Individual participant dataSharing planned: No
Related trials for Acute Ischemic Stroke
Not yet recruitingPhase 3
Metformin in Acute Ischemic Stroke
Acute Ischemic Stroke
Not yet recruiting
Safety of NRICM301 Added to Standard Care in Adults With Acute Ischemic Stroke
Acute Ischemic Stroke
Not yet recruitingPhase 2/3
A Phase II/III Clinical Study of SIM0811 in the Treatment of Acute Ischemic Stroke
Acute Ischemic Stroke AIS
RecruitingPhase 3
Albumin for Patients With Acute Large Vessel Occlusive Stroke Undergoing Endovascular Therapy -2
Acute Ischemic Stroke
RecruitingObservational study
FORWARD: Functional Outcomes in Real-World Treatment And Revascularization of Non-dominant and Distal M2 Occlusions
Acute Ischemic Stroke, Acute Ischemic Stroke (AIS) Related to a Distal Occlusion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raul Nogueira, MD principal investigator
University of Pittsburgh Medical Center (UPMC), Pittsburgh, USA
Marc Ribo, MD principal investigator
Vall D'Hebron Hospital, Barcelona, Spain
Ricardo Hanel, MD principal investigator
Baptist Health Research Institute, Jacksonville, USA
23 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Millipede System in people with Acute Ischemic Stroke, run by Perfuze at 23 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in United States, France, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ITT Cohort: Rate of Core Lab-adjudicated Reperfusion Success Within Three Passes (time frame: Intraprocedural). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05714501, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2026.