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Tusindbenet Aspiration for Revaskularisering i Stroke Study (MARRS)

12. juni 2026 opdateret af: Perfuze
Formålet med undersøgelsen er at undersøge ydeevne- og sikkerhedskarakteristika for Tusindben-systemet, når det bruges til revaskularisering af patienter med akut iskæmisk slagtilfælde på grund af store karokklusioner (LVO'er) og at registrere associerede kliniske resultater.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Iskæmisk slagtilfælde er en livstruende tilstand. Årligt får cirka 795.000 mennesker i USA et slagtilfælde.

MARRS-studiet er en interventionel, åben, enkeltarms-, multicenter-, prospektiv klinisk undersøgelse. Formålet med undersøgelsen er at evaluere præstations- og sikkerhedskarakteristika for Tusindben-systemet hos patienter med akut iskæmisk slagtilfælde på grund af LVO og at registrere kliniske resultater.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

235

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Connecticut
      • New Haven, Connecticut, Forenede Stater, 06510
        • Yale University Hospital
    • Florida
      • Jacksonville, Florida, Forenede Stater, 32207
        • Baptist Health Research Institute
      • Tampa, Florida, Forenede Stater, 33612
        • Tampa General Hosital
    • Georgia
      • Atlanta, Georgia, Forenede Stater, 30322
        • EMORY
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60637
        • University of Chicago
    • New York
      • Rochester, New York, Forenede Stater, 14620
        • University of Rochester Medical Center (URMC)
      • Stony Brook, New York, Forenede Stater, 11794
        • Stony Brook University Hospital
    • Ohio
      • Toledo, Ohio, Forenede Stater, 43614
        • University of Toledo
      • Toledo, Ohio, Forenede Stater, 43606
        • ProMedica Toledo Hospital
      • Toledo, Ohio, Forenede Stater, 43608
        • Mercy Health
    • Oregon
      • Portland, Oregon, Forenede Stater, 97239
        • Oregon Health & Science University (OHSU)
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Forenede Stater, 15213
        • University of Pittsburgh Medical Center (UPMC)
    • Tennessee
      • Memphis, Tennessee, Forenede Stater, 38120
        • Semmes Murphey Foundation
    • Texas
      • Harlingen, Texas, Forenede Stater, 78550
        • Valley Baptist Medical Center
      • Houston, Texas, Forenede Stater, 77225
        • UT Houston
  • Frankrig
      • Bordeaux, Frankrig, 33076
        • CHU Bordeaux
      • Montpellier, Frankrig
        • CHU Montpellier
      • Nancy, Frankrig
        • CHRU de Nancy
      • Nantes, Frankrig, 44093
        • CHU de Nantes - HGRL
      • Strasbourg, Frankrig, 67200
        • CHRU Strasbourg
      • Toulouse, Frankrig
        • Toulouse University Hospital -CHU Purpan
  • Spanien
      • Barcelona, Spanien
        • Vall d'Hebron
      • Madrid, Spanien, 28046
        • Hospital Universitario La Paz

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 85 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Beskrivelse

Inklusionskriterier:

  1. Forsøgspersoner i alderen ≥ 18 og ≤ 85 år.
  2. Før slag mRS-score på ≤ 1.
  3. Baseline NIHSS-score på ≥ 6.
  4. Et nyt fokalt invaliderende neurologisk underskud i overensstemmelse med akut cerebral iskæmi.

  5. Emnet tilhører en af ​​følgende undergrupper:

    1. Forsøgspersonen er ikke berettiget til trombolytisk behandling, ELLER
    2. Forsøgspersonen er berettiget til trombolytisk behandling, og trombolytisk behandling blev administreret i henhold til gældende retningslinjer for praksis.

  6. For slagtilfælde i den forreste cirkulation skal følgende billeddiagnostiske kriterier være opfyldt:

    1. Magnetic Resonance Imaging (MRI) kriterium: volumen af ​​diffusionsbegrænsning visuelt vurderet til ≤ 50 mL, ELLER
    2. Computed Tomography (CT) kriterium: Alberta Stroke Program Early CT Score (ASPECTS) 6-10 på baseline CT eller Computed Tomography Angiography (CTA) - kildebilleder eller volumen af ​​signifikant nedsat relativ Cerebral Blood Flow (rCBF) <30 % (volumen) på ≤ 50 mL, hvis der udføres CT-perfusion).
  7. For slagtilfælde i den posteriore cirkulation skal følgende billeddannelseskriterium være opfyldt: pcASPECTS-score 8 til 10 på baseline CT, CTA-kildebilleder eller Diffusion-Weighted Imaging (DWI) MRI.
  8. Interventionalisten vurderer, at arteriel punktering kan afsluttes inden for 8 timer efter debut/sidst kendt godt.
  9. Informeret samtykke opnået i overensstemmelse med de gældende landespecifikke regler og godkendt af IRB/REC.
  10. Angiografisk bekræftelse af en enkelt storkarokklusion (mTICI på 0-1) af den intrakranielle ICA (inklusive T- eller L-okklusioner), M1- eller M2-segmenterne af MCA, den intrakranielle vertebrale arterie eller den basilære arterie, der er tilgængelig for Tusindbenede system.

Ekskluderingskriterier:

  1. Kendt tidligere slagtilfælde inden for de seneste 3 måneder.
  2. Kvinder, der er kendt for at være gravide eller ammende.
  3. Efter efterforskerens mening enhver kendt komorbiditet (herunder COVID-19), der kan komplicere behandlingen eller forhindre forbedring eller opfølgning.
  4. Forsøgsperson, der i øjeblikket deltager i eller tidligere har deltaget i et andet forsøg, der involverer et forsøgsudstyr eller lægemiddel inden for 30 dage efter tilmelding.
  5. Kendt historie med svær kontrastallergi.
  6. Eksisterende neurologisk eller psykiatrisk sygdom, der ville forvirre den neurologiske eller funktionelle evaluering.
  7. Forventet levetid på mindre end 6 måneder før slagtilfælde.
  8. Kendt kokainbrug på behandlingstidspunktet.
  9. Kendt historie med koagulationsfaktormangel eller oral anti-koagulantbehandling med en International Normalized Ratio (INR) på mere end 3,0.
  10. Kendt historie med behandling med heparin inden for 48 timer med en partiel tromboplastintid (PTT) mere end to gange laboratorienormalen.
  11. Kendt historie med behandling med en direkte trombinhæmmer inden for 48 timer med en PTT mere end 1,5 gange laboratorienormalen.
  12. Kendt glucoseniveau < 50 mg/dl (2,78 mmol/L) eller > 400 mg/dl (22,20 mmol/L).
  13. Kendt blodpladetal <50.000/µL.
  14. Klinisk historie, tidligere billeddannelse eller klinisk vurdering tyder på, at den intrakranielle okklusion er kronisk.
  15. For alle patienter, alvorlig vedvarende hypertension med SBP >220 mmHg og/eller DBP >120 mmHg; for patienter behandlet med trombolytisk terapi, vedvarende hypertension trods behandling med SBP >185 mmHg og/eller DBP > 110 mmHg.
  16. Nyresvigt med serumkreatinin ≥3 mg/dL eller glomerulær filtrationshastighed (GFR) <30 ml/min.
  17. Igangværende anfald på grund af slagtilfælde.
  18. Behandles indledningsvis med intraarterielle trombolytika eller en anden neurotrombektomianordning før brug af Tusindben-systemet.
  19. Kliniske symptomer på bilateralt slagtilfælde eller slagtilfælde i flere territorier.
  20. Kendt historie med cerebral vaskulitis.
  21. Bevis på aktiv systemisk infektion (f. septikæmi). Undtagelser: almindelig forkølelse, hepatitis B-virus (HBV), hepatitis C-virus (HCV).
  22. Enhver kendt hæmoragisk eller koagulationsmangel.
  23. Bevis for aktuel intrakraniel blødning på billeddannelse.
  24. Betydelig masseeffekt med midtlinjeforskydning.
  25. Kendt arteriel tilstand i et proksimalt kar, som kræver behandling eller forhindrer adgang til okklusionsstedet eller sikker genopretning af undersøgelsesanordningen (f.eks. alvorlig stenose, fuldstændig okklusion i cervikal ICA, tandemokklusion).
  26. Mistanke eller tegn på aortadissektion, septisk embolus eller bakteriel endocarditis.
  27. Bevis på dissektion i de ekstrakranielle eller intrakranielle cerebrale arterier.
  28. Overdreven arteriel tortuositet, der kan udelukke placering af enheden som bestemt ved CTA/magnetisk resonansangiografi (MRA) og/eller konventionel angiografi.
  29. Bevis på flere vaskulære okklusioner (f.eks. bilateral anterior cirkulation, anterior/posterior cirkulation, samtidige okklusioner i den forreste cerebrale arterie (ACA) og MCA, andre samtidige ipsilaterale okklusioner i samme eller forskellige territorier).
  30. CT eller MR, der viser masseeffekt eller intrakraniel tumor (bortset fra lille meningeom, ≤ 2 cm i diameter).
  31. Kendt cancer med metastaser.
  32. Kendt aneurisme ved eller nær målbehandlingssegmentet.
  33. Angiografiske tegn på kendt eller mistænkt underliggende intrakraniel vaskulopati eller aterosklerotiske læsioner, der er ansvarlige for målokklusionen

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Enkelt arm
Tusindbenede system
Enhed: Tusindbenede system
Mekanisk trombektomi

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
ITT Cohort: Rate of Core Lab-adjudicated Reperfusion Success Within Three Passes
Tidsramme: 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.
Intraprocedural
ITT Cohort: Primary Safety Outcome
Tidsramme: 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.
From Day 0 (procedure) through to the 90 Day visit.
ITT Cohort: Supplementary Analysis of Primary Effectiveness Endpoint
Tidsramme: 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.
Intraprocedural
PP Cohort: Rate of Core Lab-adjudicated Reperfusion Success Within Three Passes
Tidsramme: 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.
Intraprocedural
PP Cohort: Primary Safety Outcome
Tidsramme: 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.
From Day 0 (procedure) through to the 90 Day visit.
PP Cohort: Supplementary Analysis of Primary Effectiveness Endpoint
Tidsramme: 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.
Intraprocedural

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
ITT Cohort: Rate of Functional Independence
Tidsramme: 90 days post-procedure

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.
90 days post-procedure
ITT Cohort: Rate of All-Cause Mortality
Tidsramme: 90 days post-procedure
Proportion of subjects that died within 90 days of the procedure
90 days post-procedure
ITT Cohort: Rate of Symptomatic Intracranial Hemorrhage (sICH)
Tidsramme: 24-hours post-procedure
Rate of symptomatic intracranial hemorrhage (sICH), as independently adjudicated by the Core Lab and Clinical Events Committee
24-hours post-procedure
ITT Cohort: Rate of All Intracranial Hemorrhage (ICH)
Tidsramme: 24 hours post-procedure
Proportion of subjects with any ICH at 24 hours, as adjudicated by the Core Lab
24 hours post-procedure
ITT Cohort: Rate of Serious Adverse Device Effects (SADEs)
Tidsramme: 90 days post-procedure
Proportion of subjects experiencing one or more SADEs within 90 days post-procedure, as adjudicated by an independent Clinical Events Committee
90 days post-procedure
ITT Cohort: Rate of Procedure-Related Serious Adverse Events (PRSAEs)
Tidsramme: 90 days post-procedure
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
90 days post-procedure
ITT Cohort: Rate of Embolization to New Territory (ENT)
Tidsramme: Intraprocedural
Proportion of subjects with distal emboli on final angiography, as adjudicated by an independent Core Lab
Intraprocedural
ITT Cohort: Proportion of Subjects With Successful Reperfusion at End of the Thrombectomy Procedure
Tidsramme: Intraprocedural
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.
Intraprocedural
ITT Cohort: Proportion of Subjects With Complete or Near Complete Reperfusion at End of the Thrombectomy Procedure
Tidsramme: Intraprocedural
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.
Intraprocedural
ITT Cohort: Proportion of Subjects With Successful Reperfusion After the First Pass With the Millipede System
Tidsramme: Intraprocedural
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.
Intraprocedural
ITT Cohort: Proportion of Subjects With Complete or Near Complete Reperfusion at the End of the First Pass With the Millipede System
Tidsramme: Intraprocedural
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.
Intraprocedural
PP Cohort: Rate of Functional Independence
Tidsramme: 90 days post-procedure

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.
90 days post-procedure
PP Cohort: Rate of All-Cause Mortality
Tidsramme: 90 days post-procedure
Proportion of subjects that died within 90 days of the procedure
90 days post-procedure
PP Cohort: Rate of Symptomatic Intracranial Hemorrhage (sICH)
Tidsramme: 24-hours post-procedure
Rate of symptomatic intracranial hemorrhage (sICH), as independently adjudicated by the Core Lab and Clinical Events Committee
24-hours post-procedure
PP Cohort: Rate of All Intracranial Hemorrhage (ICH)
Tidsramme: 24 hours post-procedure
Proportion of subjects with any ICH at 24 hours, as adjudicated by the Core Lab
24 hours post-procedure
PP Cohort: Rate of Embolization to New Territory (ENT)
Tidsramme: Intraprocedural
Proportion of subjects with distal emboli on final angiography, as adjudicated by an independent Core Lab
Intraprocedural
PP Cohort: Proportion of Subjects With Successful Reperfusion at End of the Thrombectomy Procedure
Tidsramme: Intraprocedural
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.
Intraprocedural
PP Cohort: Proportion of Subjects With Complete or Near Complete Reperfusion at End of the Thrombectomy Procedure
Tidsramme: Intraprocedural
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.
Intraprocedural
PP Cohort: Proportion of Subjects With Successful Reperfusion After the First Pass With the Millipede System
Tidsramme: Intraprocedural
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.
Intraprocedural
PP Cohort: Proportion of Subjects With Complete or Near Complete Reperfusion at the End of the First Pass With the Millipede System
Tidsramme: Intraprocedural
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.
Intraprocedural

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
ITT Cohort: Proportion of Subjects With Successful Reperfusion After the First Pass With the Millipede 088 Catheter
Tidsramme: Intraprocedural
Proportion of subjects with mTICI ≥2b after the first pass with the Millipede 088 Catheter. 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 088 Catheter, as adjudicated by an independent Core Lab.
Intraprocedural
ITT Cohort: Proportion of Subjects With Near Complete or Complete Reperfusion After the First Pass With the Millipede 088 Catheter
Tidsramme: Intraprocedural
Proportion of subjects with mTICI ≥2c after the first pass with the Millipede 088 Catheter. 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 088 Catheter, as adjudicated by an independent Core Lab.
Intraprocedural
ITT Cohort: Proportion of Subjects With M1 Occlusions Achieving Successful Reperfusion After the First Pass With the Millipede 088 Catheter
Tidsramme: Intraprocedural
Proportion of subjects with M1 occlusions achieving mTICI ≥2b after the first pass with the Millipede 088 Catheter. 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 with M1 occlusions who achieved mTICI ≥2b after the first pass with the Millipede 088 Catheter, as adjudicated by an independent Core Lab.
Intraprocedural
ITT Cohort: Proportion of Subjects With M1 Occlusions Achieving Near Complete or Complete Reperfusion After the First Pass With the Millipede 088 Catheter
Tidsramme: Intraprocedural
Proportion of subjects with M1 occlusions achieving mTICI ≥2c after the first pass with the Millipede 088 Catheter. 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 with M1 occlusions who achieved mTICI ≥2c after the first pass with the Millipede 088 Catheter, as adjudicated by an independent Core Lab.
Intraprocedural
PP Cohort: Proportion of Subjects With Successful Reperfusion After the First Pass With the Millipede 088 Catheter
Tidsramme: Intraprocedural
Proportion of subjects with mTICI ≥2b after the first pass with the Millipede 088 Catheter. 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 088 Catheter, as adjudicated by an independent Core Lab.
Intraprocedural
PP Cohort: Proportion of Subjects With Near Complete or Complete Reperfusion After the First Pass With the Millipede 088 Catheter
Tidsramme: Intraprocedural
Proportion of subjects with mTICI ≥2c after the first pass with the Millipede 088 Catheter. 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 088 Catheter, as adjudicated by an independent Core Lab.
Intraprocedural
PP Cohort: Proportion of Subjects With M1 Occlusions Achieving Successful Reperfusion After the First Pass With the Millipede 088 Catheter
Tidsramme: Intraprocedural
Proportion of subjects with M1 occlusions achieving mTICI ≥2b after the first pass with the Millipede 088 Catheter. 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 with M1 occlusions who achieved mTICI ≥2b after the first pass with the Millipede 088 Catheter, as adjudicated by an independent Core Lab.
Intraprocedural
PP Cohort: Proportion of Subjects With M1 Occlusions Achieving Near Complete or Complete Reperfusion After the First Pass With the Millipede 088 Catheter
Tidsramme: Intraprocedural
Proportion of subjects with M1 occlusions achieving mTICI ≥2c after the first pass with the Millipede 088 Catheter. 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 with M1 occlusions who achieved mTICI ≥2c after the first pass with the Millipede 088 Catheter, as adjudicated by an independent Core Lab.
Intraprocedural

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Perfuze

Efterforskere

  • Ledende efterforsker: Raul Nogueira, MD, University of Pittsburgh Medical Center (UPMC), Pittsburgh, USA
  • Ledende efterforsker: Marc Ribo, MD, Vall d'Hebron Hospital, Barcelona, Spain
  • Ledende efterforsker: Ricardo Hanel, MD, Baptist Health Research Institute, Jacksonville, USA

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

9. oktober 2023

Primær færdiggørelse (Faktiske)

8. marts 2025

Studieafslutning (Faktiske)

12. maj 2025

Datoer for studieregistrering

Først indsendt

26. januar 2023

Først indsendt, der opfyldte QC-kriterier

26. januar 2023

Først opslået (Faktiske)

6. februar 2023

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

10. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

12. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CLIN040

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ja

produkt fremstillet i og eksporteret fra U.S.A.

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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