Esta página se tradujo automáticamente y no se garantiza la precisión de la traducción. por favor refiérase a versión inglesa para un texto fuente.

Aspiración de milpiés para la revascularización en un estudio de accidente cerebrovascular (MARRS)

12 de junio de 2026 actualizado por: Perfuze
Los objetivos del estudio son examinar las características de rendimiento y seguridad del sistema Millipede cuando se utiliza para la revascularización de pacientes con accidente cerebrovascular isquémico agudo debido a oclusiones de grandes vasos (LVO) y registrar los resultados clínicos asociados.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

El accidente cerebrovascular isquémico es una afección potencialmente mortal. Anualmente, aproximadamente 795 000 personas en los Estados Unidos sufren un accidente cerebrovascular.

El estudio MARRS es una investigación clínica prospectiva, intervencionista, de etiqueta abierta, de un solo brazo y multicéntrica. Los objetivos del estudio son evaluar el rendimiento y las características de seguridad del sistema Millipede en pacientes que presentan un accidente cerebrovascular isquémico agudo debido a LVO y registrar los resultados clínicos.

Tipo de estudio

Intervencionista

Inscripción (Actual)

235

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

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

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años a 85 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Descripción

Criterios de inclusión:

  1. Sujetos de ≥ 18 y ≤ 85 años.
  2. Puntuación mRS antes del accidente cerebrovascular de ≤ 1.
  3. Puntuación NIHSS inicial de ≥ 6.
  4. Un nuevo déficit neurológico incapacitante focal compatible con isquemia cerebral aguda.

  5. El sujeto pertenece a uno de los siguientes subgrupos:

    1. El sujeto no es elegible para la terapia trombolítica, O
    2. El sujeto es elegible para la terapia trombolítica y la terapia trombolítica se administró según las pautas de práctica actuales.

  6. Para accidentes cerebrovasculares en la circulación anterior, se deben cumplir los siguientes criterios de imagen:

    1. Criterio de resonancia magnética nuclear (RMN): volumen de restricción de difusión evaluada visualmente como ≤ 50 ml, O
    2. Criterio de tomografía computarizada (CT): Alberta Stroke Program Early CT Score (ASPECTS) 6-10 en imágenes de origen de TC o angiografía por tomografía computarizada (CTA) de referencia, o volumen de flujo sanguíneo cerebral relativo significativamente reducido (rCBF) <30% (volumen de ≤ 50 mL si se realiza perfusión por TC).
  7. En el caso de accidentes cerebrovasculares en la circulación posterior, se debe cumplir el siguiente criterio de imagen: puntuación de pcASPECTS de 8 a 10 en TC de referencia, imágenes de origen de CTA o RM de imágenes ponderadas por difusión (DWI).
  8. El intervencionista estima que la punción arterial puede completarse dentro de las 8 horas posteriores al inicio/último pozo conocido.
  9. Consentimiento informado obtenido de acuerdo con las reglamentaciones específicas del país aplicables y según lo aprobado por el IRB/REC.
  10. Confirmación angiográfica de una oclusión de un solo vaso grande (mTICI de 0-1) de la ACI intracraneal (incluidas las oclusiones T o L), los segmentos M1 o M2 de la MCA, la arteria vertebral intracraneal o la arteria basilar que es accesible a la Sistema Milpiés.

Criterio de exclusión:

  1. Accidente cerebrovascular previo conocido en los últimos 3 meses.
  2. Mujeres que se sabe que están embarazadas o amamantando.
  3. En opinión del Investigador, cualquier comorbilidad conocida (incluida la COVID-19) que pueda complicar el tratamiento o impedir la mejora o el seguimiento.
  4. Sujeto que participa actualmente o ha participado anteriormente en otro ensayo que involucre un dispositivo o fármaco en investigación dentro de los 30 días posteriores a la inscripción.
  5. Antecedentes conocidos de alergia grave al contraste.
  6. Enfermedad neurológica o psiquiátrica preexistente que confundiría la evaluación neurológica o funcional.
  7. Esperanza de vida de menos de 6 meses antes del inicio del accidente cerebrovascular.
  8. Consumo conocido de cocaína en el momento del tratamiento.
  9. Antecedentes conocidos de deficiencia de factor de coagulación o tratamiento anticoagulante oral con un índice normalizado internacional (INR) de más de 3,0.
  10. Antecedentes conocidos de tratamiento con heparina dentro de las 48 horas con un tiempo de tromboplastina parcial (PTT) más de dos veces el normal de laboratorio.
  11. Antecedentes conocidos de tratamiento con un inhibidor directo de la trombina dentro de las 48 horas con un PTT más de 1,5 veces el normal de laboratorio.
  12. Nivel de glucosa conocido < 50 mg/dl (2,78 mmol/L) o > 400 mg/dl (22,20 mmol/L).
  13. Conteo conocido de plaquetas <50,000/µL.
  14. La historia clínica, las imágenes anteriores o el juicio clínico sugieren que la oclusión intracraneal es crónica.
  15. Para todos los pacientes, hipertensión severa sostenida con PAS >220 mmHg y/o PAD >120 mmHg; para pacientes tratados con terapia trombolítica, hipertensión sostenida a pesar del tratamiento con PAS > 185 mmHg y/o PAD > 110 mmHg.
  16. Insuficiencia renal con creatinina sérica ≥3 mg/dl o tasa de filtración glomerular (TFG) <30 ml/min.
  17. Convulsión en curso debido a un accidente cerebrovascular.
  18. Inicialmente tratado con trombolíticos intraarteriales o un dispositivo de neurotrombectomía diferente antes de usar el sistema Millipede.
  19. Síntomas clínicos de ictus bilateral o ictus en múltiples territorios.
  20. Antecedentes conocidos de vasculitis cerebral.
  21. Evidencia de infección sistémica activa (p. septicemia). Excepciones: resfriado común, virus de la hepatitis B (VHB), virus de la hepatitis C (VHC).
  22. Cualquier deficiencia hemorrágica o de coagulación conocida.
  23. Evidencia de hemorragia intracraneal actual en imágenes.
  24. Efecto de masa significativo con desplazamiento de la línea media.
  25. Condición arterial conocida en un vaso proximal que requiere tratamiento o impide el acceso al sitio de la oclusión o la recuperación segura del dispositivo en investigación (por ejemplo, estenosis severa, oclusión completa en la ACI cervical, oclusión en tándem).
  26. Sospecha o evidencia de disección aórtica, embolia séptica o endocarditis bacteriana.
  27. Evidencia de disección en las arterias cerebrales extracraneales o intracraneales.
  28. Tortuosidad arterial excesiva que puede impedir la colocación del dispositivo según lo determinado por CTA/angiografía por resonancia magnética (MRA) y/o angiografía convencional.
  29. Evidencia de múltiples oclusiones vasculares (por ejemplo, circulación anterior bilateral, circulación anterior/posterior, oclusiones concurrentes en la arteria cerebral anterior (ACA) y MCA, otras oclusiones ipsilaterales concurrentes en el mismo o diferentes territorios).
  30. TC o RM que muestren efecto de masa o tumor intracraneal (aparte de meningiomas pequeños, ≤ 2 cm de diámetro).
  31. Cáncer conocido con metástasis.
  32. Aneurisma conocido en o cerca del segmento de tratamiento objetivo.
  33. Evidencia angiográfica de vasculopatía intracraneal subyacente conocida o sospechada o lesiones ateroscleróticas responsables de la oclusión diana

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: N / A
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Un solo brazo
Sistema milpiés
Dispositivo: Sistema Milpiés
Trombectomía mecánica

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
ITT Cohort: Rate of Core Lab-adjudicated Reperfusion Success Within Three Passes
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
ITT Cohort: Rate of Functional Independence
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
ITT Cohort: Proportion of Subjects With Successful Reperfusion After the First Pass With the Millipede 088 Catheter
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Perfuze

Investigadores

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

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

9 de octubre de 2023

Finalización primaria (Actual)

8 de marzo de 2025

Finalización del estudio (Actual)

12 de mayo de 2025

Fechas de registro del estudio

Enviado por primera vez

26 de enero de 2023

Primero enviado que cumplió con los criterios de control de calidad

26 de enero de 2023

Publicado por primera vez (Actual)

6 de febrero de 2023

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

10 de julio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

12 de junio de 2026

Última verificación

1 de junio de 2026

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • CLIN040

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

Sí

producto fabricado y exportado desde los EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

Suscribir