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Tusenbein aspirasjon for revaskularisering i hjerneslag (MARRS)

12. juni 2026 oppdatert av: Perfuze
Målet med studien er å undersøke ytelses- og sikkerhetskarakteristikkene til tusenbeinsystemet når det brukes til revaskularisering av pasienter med akutt iskemisk hjerneslag på grunn av store karokklusjoner (LVOs) og å registrere tilhørende kliniske utfall.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Iskemisk hjerneslag er en livstruende tilstand. Årlig får omtrent 795 000 mennesker i USA hjerneslag.

MARRS-studien er en intervensjonell, åpen, enkeltarms, multisenter, prospektiv klinisk undersøkelse. Målet med studien er å evaluere ytelsen og sikkerhetskarakteristikkene til tusenbeinsystemet hos pasienter med akutt iskemisk hjerneslag på grunn av LVO og å registrere kliniske utfall.

Studietype

Intervensjonell

Registrering (Faktiske)

235

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 85 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Beskrivelse

Inklusjonskriterier:

  1. Forsøkspersoner i alderen ≥ 18 og ≤ 85 år.
  2. Førslags mRS-score på ≤ 1.
  3. Baseline NIHSS-score på ≥ 6.
  4. Et nytt fokalt invalidiserende nevrologisk underskudd i samsvar med akutt cerebral iskemi.

  5. Emnet tilhører en av følgende undergrupper:

    1. Personen er ikke kvalifisert for trombolytisk behandling, ELLER
    2. Personen er kvalifisert for trombolytisk terapi og trombolytisk terapi ble gitt i henhold til gjeldende retningslinjer for praksis.

  6. For slag i den fremre sirkulasjonen bør følgende bildekriterier oppfylles:

    1. Magnetic Resonance Imaging (MRI) kriterium: volum av diffusjonsbegrensning visuelt vurdert 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) - kildebilder, eller volum av betydelig redusert relativ cerebral blodstrøm (rCBF) <30 % (volum) på ≤ 50 mL hvis CT-perfusjon utføres).
  7. For slag i den bakre sirkulasjonen bør følgende bildekriterium være oppfylt: pcASPECTS-score 8 til 10 på baseline CT, CTA-kildebilder eller diffusjonsvektet bildebehandling (DWI) MR.
  8. Intervensjonalisten anslår at arteriell punktering kan fullføres innen 8 timer etter debut/sist kjent godt.
  9. Informert samtykke innhentet i samsvar med gjeldende landsspesifikke forskrifter og godkjent av IRB/REC.
  10. Angiografisk bekreftelse av en enkelt stor karokklusjon (mTICI på 0-1) av den intrakranielle ICA (inkludert T- eller L-okklusjoner), M1- eller M2-segmentene av MCA, den intrakraniale vertebrale arterien eller basilararterien som er tilgjengelig for Tusenbeinsystem.

Ekskluderingskriterier:

  1. Kjent tidligere slag i løpet av de siste 3 månedene.
  2. Kvinner som er kjent for å være gravide eller ammende.
  3. Etter etterforskerens mening, enhver kjent komorbiditet (inkludert COVID-19) som kan komplisere behandling eller forhindre forbedring eller oppfølging.
  4. Person som deltar i eller tidligere har deltatt i en annen utprøving som involverer en undersøkelsesenhet eller et legemiddel innen 30 dager etter påmelding.
  5. Kjent historie med alvorlig kontrastallergi.
  6. Eksisterende nevrologisk eller psykiatrisk sykdom som vil forvirre den nevrologiske eller funksjonelle evalueringen.
  7. Forventet levealder på mindre enn 6 måneder før slagdebut.
  8. Kjent kokainbruk ved behandlingstidspunktet.
  9. Kjent historie med koagulasjonsfaktormangel eller oral antikoagulantbehandling med en International Normalized Ratio (INR) på mer enn 3,0.
  10. Kjent historie med behandling med heparin innen 48 timer med en partiell tromboplastintid (PTT) mer enn to ganger laboratorienormalen.
  11. Kjent historie med behandling med en direkte trombinhemmer innen 48 timer med en PTT mer enn 1,5 ganger laboratorienormalen.
  12. Kjent glukosenivå < 50 mg/dl (2,78 mmol/L) eller > 400 mg/dl (22,20 mmol/L).
  13. Kjent blodplatetall <50 000/µL.
  14. Klinisk historie, tidligere avbildning eller klinisk vurdering tyder på at den intrakranielle okklusjonen er kronisk.
  15. For alle pasienter, alvorlig vedvarende hypertensjon med SBP >220 mmHg og/eller DBP >120 mmHg; for pasienter behandlet med trombolytisk terapi, vedvarende hypertensjon til tross for behandling med SBP >185 mmHg og/eller DBP > 110 mmHg.
  16. Nyresvikt med serumkreatinin ≥3 mg/dL eller glomerulær filtreringshastighet (GFR) <30 ml/min.
  17. Pågående anfall på grunn av hjerneslag.
  18. Behandles først med intraarterielle trombolytika eller en annen nevrotrombektomi-enhet før bruk av Tusenbeinsystemet.
  19. Kliniske symptomer på bilateralt slag eller slag i flere territorier.
  20. Kjent historie med cerebral vaskulitt.
  21. Bevis på aktiv systemisk infeksjon (f.eks. septikemi). Unntak: forkjølelse, hepatitt B-virus (HBV), hepatitt C-virus (HCV).
  22. Enhver kjent hemoragisk eller koagulasjonsmangel.
  23. Bevis for nåværende intrakraniell blødning på bildediagnostikk.
  24. Betydelig masseeffekt med midtlinjeforskyvning.
  25. Kjent arteriell tilstand i et proksimalt kar som krever behandling eller hindrer tilgang til okklusjonsstedet eller sikker gjenoppretting av undersøkelsesutstyret (for eksempel alvorlig stenose, fullstendig okklusjon i cervikal ICA, tandemokklusjon).
  26. Mistanke eller bevis på aortadisseksjon, septisk embolus eller bakteriell endokarditt.
  27. Bevis for disseksjon i de ekstrakranielle eller intrakraniale cerebrale arteriene.
  28. Overdreven arteriell tortuositet som kan utelukke plassering av utstyr som bestemt av CTA/magnetisk resonansangiografi (MRA) og/eller konvensjonell angiografi.
  29. Bevis på flere vaskulære okklusjoner (f.eks. bilateral fremre sirkulasjon, fremre/bakre sirkulasjon, samtidige okklusjoner i den fremre cerebrale arterie (ACA) og MCA, andre samtidige ipsilaterale okklusjoner i samme eller forskjellige territorier).
  30. CT eller MR som viser masseeffekt eller intrakraniell tumor (bortsett fra små meningeom, ≤ 2 cm i diameter).
  31. Kjent kreft med metastaser.
  32. Kjent aneurisme ved eller nær målbehandlingssegmentet.
  33. Angiografiske bevis på kjent eller mistenkt underliggende intrakraniell vaskulopati eller aterosklerotiske lesjoner som er ansvarlige for målokklusjonen

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Enkel arm
Tusenbeinsystem
Enhet: Tusenbeinsystem
Mekanisk trombektomi

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Perfuze

Etterforskere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

9. oktober 2023

Primær fullføring (Faktiske)

8. mars 2025

Studiet fullført (Faktiske)

12. mai 2025

Datoer for studieregistrering

Først innsendt

26. januar 2023

Først innsendt som oppfylte QC-kriteriene

26. januar 2023

Først lagt ut (Faktiske)

6. februar 2023

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

10. juli 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

12. juni 2026

Sist bekreftet

1. juni 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • CLIN040

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Ja

produkt produsert i og eksportert fra USA

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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