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adaptatiVe Endovascular Strategy to the CloT MRI in Large Intracranial Vessel Occlusion (VECTOR)

15 de diciembre de 2022 actualizado por: Nantes University Hospital

In the VECTOR trial, the aim is to analyze, in case of SVS+ occlusions, a first line Embotrap II added to CA combined strategy compare to CA alone strategy.

Many practitioners are convinced that a first line strategy with CA alone is easy, safe, rapid and efficient. Maybe, after two, three, four ... passes and with the secondary help of a combined strategy, a high rate of eTICI 2b/3 could be reached with a CA first line strategy. But this could go with a higher number of passes, a waste of time and a suboptimal angiographic results (eTICI 2b) due to distal emboli, especially in case of friable, non-well organized, red blood cell rich (RBC) i.e. SVS + thrombi (25-28). This could, be related to worst clinical outcome at 3 months. VECTOR asks a relevant question: Do the invetigators have to add the use of an Embotrap II or III to the CA, from the first passes, in case of SVS+ clots?

Descripción general del estudio

Descripción detallada

Sudden occlusion of an intracranial artery by a thrombus represents the initial and pivotal event of large vessel occlusion acute ischemic stroke (AIS). The primary goal of AIS treatment is to re-open this artery with intravenous tissue-type plasminogen activator infusion (IV t-PA) and/or endovascular therapy (EVT). Thrombus characterization could be useful to predict AIS etiology, IV t-PA response and to adapt the device or technique for EVT. Especially, approaching the red blood cell (RBC) content of the thrombus would be helpful to plan a treatment strategy or identify specific EVT approaches in order to maximize the rate of early successful reperfusion .

The susceptibility vessel sign (SVS) on T2*-MRI sequence is defined as a hypo-intense signal exceeding the diameter of the contralateral artery located at the site of the thrombus. Several studies have demonstrated SVS to be a negative predictor of early reperfusion after IV t-PA and an incentive to EVT . Two studies identified a correlation between the SVS and the thrombus composition (specifically the RBC composition). In the ASTER trial, the presence of SVS impacted the success rate of the EVT strategy. In the SVS (+) sub-population of this study, compared to contact aspiration (CA), patients treated with stent retrievers achieved higher rates of complete reperfusion within fewer passes, which translated into a better functional outcome. In the absence of SVS, no differences were observed between the two techniques. Furthermore; based on the ASTER and THRACE trial populations treated with stent retriever as a first line strategy, a higher rate of favorable clinical outcome at 3 months in SVS (+) patients was recently found . Hence, that differences in terms of reperfusion results are thought to be related to different clot compositions between SVS + and SVS - occlusions.

In the VECTOR trial, the aim is to analyze, in case of SVS+ occlusions, a first line Embotrap II added to CA combined strategy compare to CA alone strategy.

Many practitioners are convinced that a first line strategy with CA alone is easy, safe, rapid and efficient. Maybe, after two, three, four passes and with the secondary help of a combined strategy, a high rate of eTICI 2b/3 could be reached with a CA first line strategy. But this could go with a higher number of passes, a waste of time and a suboptimal angiographic results (eTICI 2b) due to distal emboli, especially in case of friable, non-well organized, red blood cell rich (RBC) i.e. SVS + thrombi. This could, be related to worst clinical outcome at 3 months.

VECTOR asks a relevant question: Do the investigators have to add the use of an Embotrap II or III to the CA, from the first passes, in case of SVS+ clots? The hypothesis in the VECTOR trial is that the Embotrap II or III, thanks to its dedicated design will help to the stabilization of friable clots and allow better retrieving of SVS + thrombi in a lower number of passes.

Tipo de estudio

Intervencionista

Inscripción (Actual)

526

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

      • Amiens, Francia
        • CHU Amiens-Picardie
      • Angers, Francia
        • CH Angers
      • Bayonne, Francia, 64109
        • CH Cote Basque
      • Bordeaux, Francia
        • Hôpital Pellegrin - CHU BORDEAUX
      • Brest, Francia
        • CHRU Brest
      • Le Kremlin-Bicêtre, Francia
        • Hôpital Bicêtre
      • Lille, Francia
        • Hôpital Roger Salengro - CHR Lille
      • Limoges, Francia
        • CHU Limoges
      • Lyon, Francia
        • Hospices Civils LYON
      • Marseille, Francia, 13385
        • CHU Marseille - Hôpital la Timone
      • Montpellier, Francia
        • CHU Gui de Chauliac
      • Nancy, Francia
        • CHU Nancy
      • Nantes, Francia
        • CHU de Nantes
      • Paris, Francia, 75019
        • Fondation Ophtalmologique Adolphe de Rothschild
      • Paris, Francia
        • La Pitié Salpêtrière
      • Paris, Francia
        • Hôpital Ste Anne
      • Pau, Francia, 64000
        • CH Pau
      • Reims, Francia
        • Hôpital Maison Blanche - CHU Reims
      • Rennes, Francia
        • Hopital Pontchaillou - CHU Rennes
      • Strasbourg, Francia, 67000
        • CHU Strasbourg
      • Suresnes, Francia
        • Hopital FOCH
      • Tours, Francia
        • Hôpital Bretonneau - CHU Tours
      • Vannes, Francia
        • CH Bretagne Atlantique

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 y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Age 18 and older (i.e., candidates must have had their 18th birthday)
  • Puncture carried out within 24 hours of first symptoms
  • Suitable 1.5T MRI T2 * Gradient echo that shows a clear susceptibility vessel sign facing the occlusion
  • Neuroimaging demonstrates large vessel proximal occlusion (distal ICA through MCA bifurcation, M1 or proximal M2)
  • Patient or trustworthy person informed about the study and having orally consented to participation in the study. If the patient is unable to receive information and no trustworthy person can be contacted during screening for the study, trial inclusion will be completed as an emergency procedure by the investigator, in compliance with the French laws
  • With or without intravenous thrombolysis

Exclusion Criteria:

  • Absence of large vessel occlusion on non-invasive imaging
  • Known or suspected pre-existing (chronic) large vessel occlusion in the symptomatic territory
  • Suspected pregnancy; if, in a woman is of child-bearing potential, a urine or serum beta HCG test is positive
  • Severe contrast medium allergy or absolute contraindication to use of iodinated products
  • Clinical history, past imaging or clinical judgment suggests that the intracranial occlusion is chronic
  • Patient has severe or fatal comorbidities that will likely prevent improvement or follow-up or that will render the procedure unlikely to benefit the patient
  • Acute ischemic stroke involving posterior circulation (vertebro-basilar occlusion)
  • Angiographic evidence of carotid dissection or tandem cervical occlusion or stenosis requiring treatment
  • Pregnant or breast-feeding women
  • Patient benefiting from a legal protection
  • Non-membership of a national insurance scheme
  • Opposition of the patient or (in case of inclusion as a matter of urgency) of the trustworthy person
  • Patient with modified Rankin score > 3 before qualifying stroke

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: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: combined EMBOTRAP II or III and Contact Aspiration
refer to title
Comparador activo: Contact Aspiration alone
refer to title

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
The rate of near to complete reperfusion after 3 passes of the device defined by a modified treatment in cerebral infarction (eTICI) score of 2c/3
Periodo de tiempo: At Day 0 immediately after 3 passes
Preliminary data suggested in case of SVS+ occlusions a superiority of the first line SR strategy in terms of eTICI2c/3 after 3 passes compared to first line CA alone.The first pass (FPE) is an ambitious technical endpoint defined as a successful reperfusion obtained after the first pass that has been recently associated with an increased probability of favorable clinical outcome, a reduced mortality rate and procedural adverse events.However, this constitutes a "very technical" endpoint and the external validity in daily practice would be reduced compared to the three passes cut-off.Even if a FPE eTICI 2b, 2c or 3 has shown better clinical outcome compared to a final eTICI 2b, 2c or 3,there is no study that has proved the better clinical outcome when compared FPE eTICI 2b,2c or 3 to three passes eTICI 2b,2c or 3.Last, there was no preliminary data that suggests in case of SVS+ occlusions, a superiority of the first pass SR strategy in terms eTICI2c/3 compared to first pass CA alone.
At Day 0 immediately after 3 passes

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Near to complete first-pass effect
Periodo de tiempo: Day 0 immediately after first pass
Defined as a eTICI 2c/3 after first pass device
Day 0 immediately after first pass
Complete first-pass effect
Periodo de tiempo: Day 0 immediately after first pass
Defined as a eTICI 3 after first pass device
Day 0 immediately after first pass
Complete reperfusion
Periodo de tiempo: Day 0 immediately after three passes
Defined as eTICI 3 after three passes
Day 0 immediately after three passes
Final near to complete reperfusion
Periodo de tiempo: Day 0 at the end of the intervention
Defined as eTICI 2c/3 final
Day 0 at the end of the intervention
Final complete reperfusion
Periodo de tiempo: Day 0 at the end of the intervention
Defined as eTICI 3
Day 0 at the end of the intervention
Time to achieve eTICI 2c or better revascularization
Periodo de tiempo: Day 0
Time to achieve eTICI 2c or better revascularization
Day 0
Time between groin puncture to clot contact
Periodo de tiempo: Day 0
Time between groin puncture to clot contact
Day 0
Rate of functional independence
Periodo de tiempo: At 90days
Defined as a modified Rankin scale (mRS) 0-2
At 90days
Rate of excellent functional outcome
Periodo de tiempo: At 90days
Defined as a mRS 0-1
At 90days
The distribution of mRs scores
Periodo de tiempo: At 90days
Combining scores of 9 and 10
At 90days
Change in NIHSS from baseline to 24 hours
Periodo de tiempo: Baseline and 24hours
Change in NIHSS
Baseline and 24hours
Rate of symptomatic and asymptomatic intracerebral hemorrhage
Periodo de tiempo: At 24hrs
Assessment of symptomatic and asymptomatic intracerebral hemorrhage at MRI or CT scan 24h after thrombectomy
At 24hrs
Rate of parenchymal hematoma type 1 and 2
Periodo de tiempo: At 24hrs
Assessment of parenchymal hematoma type 1 and 2
At 24hrs
Rate of all-cause mortality at 90 days
Periodo de tiempo: At 90days
Assessment of all-cause mortality at 90 days
At 90days
Rate of periprocedural complications
Periodo de tiempo: At 90days
Occurrence of emboli to new territory, vasospasm, dissection, perforation and subarachnoid hemorrhage
At 90days

Colaboradores e Investigadores

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

Investigadores

  • Investigador principal: Romain Bourcier, CHU Nantes

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)

26 de noviembre de 2019

Finalización primaria (Actual)

14 de febrero de 2022

Finalización del estudio (Actual)

3 de octubre de 2022

Fechas de registro del estudio

Enviado por primera vez

7 de octubre de 2019

Primero enviado que cumplió con los criterios de control de calidad

23 de octubre de 2019

Publicado por primera vez (Actual)

25 de octubre de 2019

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

16 de diciembre de 2022

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

15 de diciembre de 2022

Última verificación

1 de diciembre de 2022

Más información

Términos relacionados con este estudio

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.

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. .

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