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EndovascularTherapy Versus Standard Medical Terapy for Intracranial Large Vessel Occlusion in 24 Hours to 30 Days

21 de septiembre de 2026 actualizado por: Xuan Sun

EndovascularTherapy Versus Standard Medical Terapy for Intracranial Large Vessel Occlusion in 24 Hours to 30 Days: A Prospective, Multicenter, Real-world Cohort Trial

This study is a prospective, multicenter, observational cohort study using a real-world study design. The aim of this study is to compare functional and safety outcomes of intravascular recanalization therapy (with COSIS distal stent protection technology strategy as the core) combined with standard drug therapy in improving functional outcomes in patients with intracranial large vessel occlusion in the ultra late window (24 hours-30 days) compared with standard drug therapy alone.

Descripción general del estudio

Descripción detallada

Patients with ischemic stroke whose onset or last known well (LKW) ranged from 24 hours to 30 days, who were confirmed by imaging to have intracranial large vessel occlusion and may still have brain tissue that can be saved were included. The study did not interfere with the choice of treatment options. Patients received intravascular therapy or standard drug treatment, which was determined by clinicians according to the condition, imaging characteristics and the joint decision of doctors and patients. According to the actual treatment of patients, the intravascular treatment cohort and the standard drug treatment cohort were formed, in which the intravascular treatment was centered on the COSIS distal stent protection strategy. The primary outcome is proportion of patients with functional independence defined as mRS score of 0-2 at 90 days after enrollment.

Tipo de estudio

De observación

Inscripción (Estimado)

150

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.

Estudio Contacto

  • Nombre: Xuan Sun, MD
  • Número de teléfono: 13810926284
  • Correo electrónico: sxuan@yeah.net

Ubicaciones de estudio

    • Beijing Municipality
      • Beijing, Beijing Municipality, Porcelana, 100070
        • Beijing Tiantan Hospitall, Capital Medical University
        • Contacto:
          • Xuan Sun, MD
          • Número de teléfono: +8613810926284
          • Correo electrónico: sxuan@yeah.net

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

Método de muestreo

Muestra no probabilística

Población de estudio

All research centers continuously screened eligible patients according to unified standards. The study did not interfere with the choice of treatment options. Whether the patients received intravascular therapy was determined by clinicians according to the condition, imaging characteristics, treatment risk and the joint decision of doctors and patients.

This is a prospective multicenter observational registry-based cohort study. Endovascular treatment is a routine clinical interventional procedure. The decision whether to perform endovascular treatment is made by treating clinicians, not assigned by study investigators. Investigators only collect real-world clinical data and follow-up outcomes of enrolled participants.

Descripción

Inclusion Criteria:

  1. Age≥18 years
  2. The clinical diagnosis was ischemic stroke, and imaging confirmed the presence of intracranial large vessel occlusion
  3. The time from LKW or the time of finding symptoms is 24 hours to 72 hours; or more than 72 hours but not more than 30 days, and there are neurological deterioration or fluctuation
  4. Imaging findings suggest that there may still be salvageable brain tissue, which meets any of the following conditions: perfusion imaging examination shows that the ischemic core volume < 70 ml and the mismatch ratio > 1.2; CTA or DSA showed moderate or good collateral circulation; MRI-DWI showed a significant mismatch between lesion size and clinical symptoms
  5. The modified Rankin Scale score (mRS) before onset was 0-1
  6. The subjects themselves or their legal representatives voluntarily participated in the study and signed written informed consent

Exclusion Criteria:

  1. Large area cerebral infarction or imaging showed obvious space occupying effect, such as ASPECTS<6 points,or brainstem infarction area exceeded 1/3 of the corresponding anatomical area
  2. Isolated extracranial carotid or vertebral artery occlusion
  3. Intracranial tumors, arteriovenous malformations or other serious intracranial diseases that may significantly affect the evaluation of the outcome of the study
  4. Intracranial hemorrhage occurred in the past 3 months
  5. There is a risk of severe coagulation dysfunction, active bleeding or other high bleeding that cannot be corrected
  6. Severe liver and kidney function damage, which may affect treatment or follow-up
  7. Pregnant or lactating women
  8. The estimated survival time is less than 1 year
  9. Unable to complete 90-day clinical follow-up or main outcome assessment
  10. Participating in other interventional clinical trials that may affect the treatment or outcome evaluation of this study
  11. Other circumstances that the researcher believes are not suitable for participating in this study

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

  • Modelos observacionales: COHORT
  • Perspectivas temporales: PROSPECTIVE

Cohortes e Intervenciones

Grupo / Cohorte
Intervención / Tratamiento
Endovascular Treatment Cohort

Intravascular therapy combined with standard drug therapy, in which the core of intravascular therapy is the cosis distal stent protection strategy.

The recanalization strategy with COSIS distal stent protection technology as the core was used in endovascular treatment.In addition to thrombus removal, the device mainly uses its distal closed basket structure and stent guide wire to form protection and anchor fulcrum at the distal end of occlusion, so as to assist in balloon dilatation, thrombus removal or stent implantation of complex occlusive lesions, and reduce thrombus escape.

Standard Medical Therapy Cohort

Standard drug therapy alone.It mainly includes antiplatelet therapy or anticoagulation therapy, lipid-lowering therapy, blood pressure and blood glucose management, etc.

Standard drug therapy is implemented in accordance with the current guidelines for the diagnosis and treatment of cerebrovascular diseases and the routine of each center, mainly including antiplatelet or anticoagulation therapy, lipid-lowering therapy, blood pressure and blood glucose management, etc.

The drug name, dose, route of administration, frequency of administration and course of treatment are determined by the clinician according to the patient's condition. The study only recorded the actual drug treatment and important adjustments.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
The proportion of patients with functional independence defined as mRS score of 0 - 2 at 90 days after enrollment
Periodo de tiempo: 90 days after enrollment

The modified Rankin scale (mRS) ranged from 0 to 6, with a score of 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but remaining able to walk unassisted, 4 moderately severe disability,5 severe disability, and 6 death.

90 days after enrollment

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
The overall distribution of mRS at 90 days after enrollment
Periodo de tiempo: 90 days after enrollment

The modified Rankin scale (mRS) ranged from 0 to 6, with a score of 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but remaining able to walk unassisted, 4 moderately severe disability,5 severe disability, and 6 death.

90 days after enrollment
National Institutes of Health Stroke Scale (NIHSS) score 24 hours after treatment
Periodo de tiempo: 24 hours after treatment

The National Institute of Health Stroke Scale (NIHSS) ranged from 0 to 42, with higher scores indicating greater neurologic deficits.

24 hours after treatment
National Institutes of Health Stroke Scale (NIHSS) score at discharge
Periodo de tiempo: At discharge

The National Institute of Health Stroke Scale (NIHSS) ranged from 0 to 42, with higher scores indicating greater neurologic deficits.

At discharge
National Institutes of Health Stroke Scale (NIHSS) score 30 days after enrollment
Periodo de tiempo: 30 days after enrollment

The National Institute of Health Stroke Scale (NIHSS) ranged from 0 to 42, with higher scores indicating greater neurologic deficits.

30 days after enrollment
National Institutes of Health Stroke Scale (NIHSS) score 90 days after enrollment
Periodo de tiempo: 90 days after enrollment

The National Institute of Health Stroke Scale (NIHSS) ranged from 0 to 42, with higher scores indicating greater neurologic deficits.

90 days after enrollment
The recurrence rate of stroke within 90 days after enrollment
Periodo de tiempo: 90 days after enrollment

The recurrence rate of stroke within 90 days after enrollment.

90 days after enrollment
Transient ischemic attack within 90 days after enrollment
Periodo de tiempo: 90 days after enrollment

Transient ischemic attack within 90 days after enrollment.

90 days after enrollment
All-cause mortality within 90 days after enrollment
Periodo de tiempo: 90 days after enrollment

All-cause mortality within 90 days after enrollment.

90 days after enrollment
Revascularization of target vessels within 90 days after enrollment
Periodo de tiempo: 90 days after enrollment

Revascularization of target vessels within 90 days after enrollment.

90 days after enrollment
The technical success rate of the intravascular treatment cohort,successful recanalization of the target vessel with residual stenosis <50% and final mTICI grade≥2b
Periodo de tiempo: At the end of the procedure

The technical success rate of the intravascular treatment cohort,successful recanalization of the target vessel with residual stenosis <50% and final mTICI grade≥2b.

At the end of the procedure
Degree of recanalization in the intravascular treatment cohort
Periodo de tiempo: At the end of the procedure

Degree of recanalization in the intravascular treatment cohort.The mTICI scale evaluates angiographic recanalization after endovascular therapy for acute ischemic stroke. Grades range from 0 (no perfusion) to 3 (complete recanalization). mTICI grade≥2b is defined as successful recanalization.

At the end of the procedure
Operation time of intravascular treatment cohort
Periodo de tiempo: During the procedure

Operation time of intravascular treatment cohort.

During the procedure
Distribution of mRS scores at 6 months after enrollment
Periodo de tiempo: 6 months after enrollment

The modified Rankin scale (mRS) ranged from 0 to 6, with a score of 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but remaining able to walk unassisted, 4 moderately severe disability,5 severe disability, and 6 death.

6 months after enrollment
The recurrence rate of stroke at 6 months after enrollment
Periodo de tiempo: 6 months after enrollment

The recurrence rate of stroke at 6 months after enrollment.

6 months after enrollment
Transient ischemic attack at 6 months after enrollment
Periodo de tiempo: 6 months after enrollment

Transient ischemic attack at 6 months after enrollment.

6 months after enrollment
All-cause mortality at 6 months after enrollment
Periodo de tiempo: 6 months after enrollment

All-cause mortality at 6 months after enrollment.

6 months after enrollment
Revascularization of target vessels at 6 months after enrollment
Periodo de tiempo: 6 months after enrollment

Revascularization of target vessels at 6 months after enrollment.

6 months after enrollment
Distribution of mRS scores at 12 months after enrollment
Periodo de tiempo: 12 months after enrollment

The modified Rankin scale (mRS) ranged from 0 to 6, with a score of 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but remaining able to walk unassisted, 4 moderately severe disability,5 severe disability, and 6 death.

12 months after enrollment
The recurrence rate of stroke at 12 months after enrollment
Periodo de tiempo: 12 months after enrollment

The recurrence rate of stroke at 12 months after enrollment.

12 months after enrollment
Transient ischemic attack at 12 months after enrollment
Periodo de tiempo: 12 months after enrollment

Transient ischemic attack at 12 months after enrollment.

12 months after enrollment
All-cause mortality at 12 months after enrollment
Periodo de tiempo: 12 months after enrollment

All-cause mortality at 12 months after enrollment.

12 months after enrollment
Revascularization of target vessels at 12 months after enrollment
Periodo de tiempo: 12 months after enrollment

Revascularization of target vessels at 12 months after enrollment.

12 months after enrollment

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Adverse events within 12 months after enrollment
Periodo de tiempo: 12 months after enrollment

Adverse events events within 12 months after enrollment.

12 months after enrollment
Serious adverse events within 12 months after enrollment
Periodo de tiempo: 12 months after enrollment

Serious adverse events within 12 months after enrollment.

12 months after enrollment
Symptomatic intracranial hemorrhage within 12 months after enrollment
Periodo de tiempo: 12 months after enrollment

Symptomatic intracranial hemorrhage within 12 months after enrollment.

12 months after enrollment
Ischemic stroke within 12 months after enrollment
Periodo de tiempo: 12 months after enrollment

Ischemic stroke within 12 months after enrollment.

12 months after enrollment
Hemorrhagic stroke within 12 months after enrollment
Periodo de tiempo: 12 months after enrollment

Hemorrhagic stroke within 12 months after enrollment.

12 months after enrollment
All-cause death and other important clinical safety events within 12 months after enrollment
Periodo de tiempo: 12 months after enrollment

All-cause death and other important clinical safety events within 12 months after enrollment.

12 months after enrollment
Proportion of at least one complication in the intravascular therapy cohort
Periodo de tiempo: Perioperative

The intravascular treatment cohort included perioperative vascular dissection, vascular perforation or rupture, distal embolization, acute occlusion, re-occlusion, cerebral hyperperfusion syndrome and puncture site complications.

Perioperative

Colaboradores e Investigadores

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

Patrocinador

Investigadores

  • Investigador principal: Xuan Sun, MD, Beijing Tiantan Hospital

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 (Estimado)

1 de octubre de 2026

Finalización primaria (Estimado)

31 de diciembre de 2028

Finalización del estudio (Estimado)

31 de diciembre de 2029

Fechas de registro del estudio

Enviado por primera vez

9 de septiembre de 2026

Primero enviado que cumplió con los criterios de control de calidad

21 de septiembre de 2026

Publicado por primera vez (Actual)

28 de septiembre de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

28 de septiembre de 2026

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

21 de septiembre de 2026

Última verificación

1 de septiembre de 2026

Más información

Términos relacionados con este estudio

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.

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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