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Tusenfotingaspiration för revaskularisering i strokestudie (MARRS)

12 juni 2026 uppdaterad av: Perfuze
Syftet med studien är att undersöka prestanda- och säkerhetsegenskaperna hos tusenfotingssystemet när det används för revaskularisering av patienter med akut ischemisk stroke på grund av stora kärlocklusioner (LVO) och att registrera associerade kliniska resultat.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

Ischemisk stroke är ett livshotande tillstånd. Årligen får cirka 795 000 personer i USA en stroke.

MARRS-studien är en interventionell, öppen, enarms-, multicenter, prospektiv klinisk undersökning. Syftet med studien är att utvärdera prestandan och säkerhetsegenskaperna hos tusenfotingssystemet hos patienter med akut ischemisk stroke på grund av LVO och att registrera kliniska resultat.

Studietyp

Interventionell

Inskrivning (Faktisk)

235

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 85 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Beskrivning

Inklusionskriterier:

  1. Försökspersoner i åldern ≥ 18 och ≤ 85 år.
  2. Förslags mRS-poäng på ≤ 1.
  3. Baslinje NIHSS-poäng på ≥ 6.
  4. Ett nytt fokalt invalidiserande neurologiskt underskott som överensstämmer med akut cerebral ischemi.

  5. Ämnet tillhör en av följande undergrupper:

    1. Patienten är inte kvalificerad för trombolytisk behandling, ELLER
    2. Försökspersonen är berättigad till trombolytisk terapi och trombolytisk terapi administrerades enligt gällande riktlinjer.

  6. För stroke i den främre cirkulationen bör följande avbildningskriterier uppfyllas:

    1. Magnetic Resonance Imaging (MRI) kriterium: diffusionsvolymbegränsning visuellt bedömd som ≤ 50 ml, ELLER
    2. Kriterium för datortomografi (CT): Alberta Stroke Program Early CT Score (ASPECTS) 6-10 på baslinje-CT eller Computed Tomography Angiography (CTA) - källbilder, eller volymen av signifikant sänkt relativ cerebralt blodflöde (rCBF) <30 % (volym på ≤ 50 mL om CT-perfusion utförs).
  7. För stroke i den bakre cirkulationen bör följande avbildningskriterium vara uppfyllt: pcASPECTS-poäng 8 till 10 på baslinje-CT, bilder från CTA-källor eller Diffusion-Weighted Imaging (DWI) MRI.
  8. Interventionalisten uppskattar att arteriell punktering kan slutföras inom 8 timmar från början/senast kända väl.
  9. Informerat samtycke erhållet i enlighet med tillämpliga landsspecifika bestämmelser och som godkänts av IRB/REC.
  10. Angiografisk bekräftelse av en enda stor kärlocklusion (mTICI på 0-1) av den intrakraniella ICA (inklusive T- eller L-ocklusioner), M1- eller M2-segmenten av MCA, den intrakraniella vertebrala artären eller basilarartären som är tillgänglig för Millipede System.

Exklusions kriterier:

  1. Känd tidigare stroke under de senaste 3 månaderna.
  2. Kvinnor som är kända för att vara gravida eller ammar.
  3. Enligt utredarens uppfattning, alla kända samsjukligheter (inklusive COVID-19) som kan komplicera behandlingen eller förhindra förbättring eller uppföljning.
  4. Försöksperson som för närvarande deltar i eller har tidigare deltagit i en annan prövning som involverar en undersökningsenhet eller läkemedel inom 30 dagar efter registreringen.
  5. Känd historia av svår kontrastallergi.
  6. Redan existerande neurologisk eller psykiatrisk sjukdom som skulle förvirra den neurologiska eller funktionella utvärderingen.
  7. Förväntad livslängd på mindre än 6 månader före strokedebut.
  8. Känd kokainanvändning vid tidpunkten för behandling.
  9. Känd historia av koagulationsfaktorbrist eller oral antikoagulantbehandling med en International Normalized Ratio (INR) på mer än 3,0.
  10. Känd historia av behandling med heparin inom 48 timmar med en partiell tromboplastintid (PTT) mer än två gånger den normala laboratoriet.
  11. Känd historia av behandling med en direkt trombinhämmare inom 48 timmar med en PTT mer än 1,5 gånger laboratorienormalen.
  12. Känd glukosnivå < 50 mg/dl (2,78 mmol/L) eller > 400 mg/dl (22,20 mmol/L).
  13. Känt trombocytantal <50 000/µL.
  14. Klinisk historia, tidigare avbildning eller klinisk bedömning tyder på att den intrakraniella ocklusionen är kronisk.
  15. För alla patienter, svår ihållande hypertoni med SBP >220 mmHg och/eller DBP >120 mmHg; för patienter behandlade med trombolytisk terapi, ihållande hypertoni trots behandling med SBP >185 mmHg och/eller DBP > 110 mmHg.
  16. Njursvikt med serumkreatinin ≥3 mg/dL eller glomerulär filtrationshastighet (GFR) <30 ml/min.
  17. Pågående anfall på grund av stroke.
  18. Behandlas initialt med intraarteriella trombolytika eller en annan neurotrombektomianordning innan tusenfotingssystemet används.
  19. Kliniska symtom på bilateral stroke eller stroke i flera territorier.
  20. Känd historia av cerebral vaskulit.
  21. Bevis på aktiv systemisk infektion (t.ex. sepsis). Undantag: vanlig förkylning, hepatit B-virus (HBV), hepatit C-virus (HCV).
  22. Alla kända hemorragiska eller koagulationsbrist.
  23. Bevis på aktuell intrakraniell blödning på bildbehandling.
  24. Betydande masseffekt med mittlinjeförskjutning.
  25. Känt arteriellt tillstånd i ett proximalt kärl som kräver behandling eller förhindrar tillgång till platsen för ocklusion eller säker återhämtning av undersökningsanordningen (till exempel allvarlig stenos, fullständig ocklusion i cervikal ICA, tandemocklusion).
  26. Misstanke eller bevis på aortadissektion, septisk embolus eller bakteriell endokardit.
  27. Bevis på dissektion i de extrakraniella eller intrakraniella cerebrala artärerna.
  28. Överdriven arteriell tortuositet som kan förhindra placering av enheten enligt CTA/magnetisk resonansangiografi (MRA) och/eller konventionell angiografi.
  29. Bevis på multipla vaskulära ocklusioner (t.ex. bilateral främre cirkulation, främre/bakre cirkulation, samtidiga ocklusioner i den främre cerebrala artären (ACA) och MCA, andra samtidiga ipsilaterala ocklusioner i samma eller olika territorier).
  30. CT eller MRI som visar masseffekt eller intrakraniell tumör (förutom små meningiom, ≤ 2 cm i diameter).
  31. Känd cancer med metastaser.
  32. Känt aneurysm vid eller nära målbehandlingssegmentet.
  33. Angiografiska bevis på känd eller misstänkt underliggande intrakraniell vaskulopati eller aterosklerotiska lesioner som är ansvariga för målocklusionen

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: N/A
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Enkelarm
Tusenfotssystem
Enhet: Tusenfotssystem
Mekanisk trombektomi

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
ITT Cohort: Rate of Core Lab-adjudicated Reperfusion Success Within Three Passes
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
ITT Cohort: Rate of Functional Independence
Tidsram: 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
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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

Andra resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
ITT Cohort: Proportion of Subjects With Successful Reperfusion After the First Pass With the Millipede 088 Catheter
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Perfuze

Utredare

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

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

9 oktober 2023

Primärt slutförande (Faktisk)

8 mars 2025

Avslutad studie (Faktisk)

12 maj 2025

Studieregistreringsdatum

Först inskickad

26 januari 2023

Först inskickad som uppfyllde QC-kriterierna

26 januari 2023

Första postat (Faktisk)

6 februari 2023

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

10 juli 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

12 juni 2026

Senast verifierad

1 juni 2026

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • CLIN040

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Ja

produkt tillverkad i och exporterad från U.S.A.

Nej

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