- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07618052
Efficacy and Safety of Bailout Intracranial Angioplasty or Stenting After Thrombectomy for Acute Intracranial Atherosclerotic Large Vessel Occlusion (ANGEL-REBOOT 2)
Efficacy and Safety of Bailout Intracranial Angioplasty or Stenting After Thrombectomy for Acute Intracranial Atherosclerotic Large Vessel Occlusion: A Clinical Trial Combining a Randomized Controlled Trial and a Concurrent Prospective Observational Cohort
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Feng Gao, MD
- Número de teléfono: 13581936066
- Correo electrónico: gaofengletter@sina.com
Ubicaciones de estudio
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Beijing Municipality
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Beijing, Beijing Municipality, Porcelana, 100070
- Beijing Tiantan Hospital, Capital Medical University
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Age≥18 years.
- Time interval from symptom onset to puncture ≤24 hours.
- National Institute of Health Stroke Scale (NIHSS) Score ≥6 before randomisation.
- Pre-stroke modified Rankin Scale (mRS) of 0-2.
- Each patient or their legal representative must provide written informed consent before enrolment.
Imaging Inclusion Criteria:
- For patients with anterior circulation stroke, a CT or DWI-based Alberta Stroke Program Early CT Score (ASPECTS) of ≥6 is required.
- For patients with posterior circulation stroke, CT or DWI-based posterior circulation ASPECTS (pc-ASPECTS) of ≥6 and Pons-Midbrain Index (PMI) of <3 are required.
Angiographic Inclusion Criteria:
- Acute ischemic stroke (AIS) resulting from large vessel occlusion (LVO) involving the intracranial internal carotid artery, the M1 segment of the middle cerebral artery, the V4 segment of the vertebral artery, or the basilar artery, with high suspicion of intracranial atherosclerotic stenosis-related large-vessel occlusion (ICAS-LVO).
Part 1 (RCT): Successful recanalization of the occluded artery (eTICI ≥ 2b) with residual stenosis ≥ 70% after 1-2 thrombectomy attempts.
Part 2 (Prospective observational cohort): Failure to achieve successful recanalization (eTICI 0-2a) after at least two thrombectomy attempts. All other inclusion criteria are identical to those for Part 1.
- Occluded artery amenable to angioplasty (balloon dilation and/or stenting) by the judgement of the treating neurointerventionalist.
Exclusion Criteria:
- Any sign of intracranial hemorrhage (ICH, except microbleeds) on baseline brain imaging.
- CT or MR imaging evidence of intracranial tumor (except small meningiomas or cerebral aneurysms < 3mm in diameter).
- Any indication of intracranial vessel perforation during thrombectomy..
- Presence of tandem lesion in the extracranial segment of the internal carotid artery or vertebral artery, or intracranial arterial stenosis with distal vessel occlusion..
- Stenosis caused by non-atherosclerotic intracranial arteriopathies (e.g., autoimmune vasculitis, vasospasm, cerebral artery dissection).
- Evidence of cardioembolism (e.g., atrial fibrillation, prosthetic heart valve, infective endocarditis, mitral stenosis, atrial myxoma, intracardiac thrombus/vegetation, left ventricular aneurysm, etc.).
- Contraindication for antiplatelet treatment.
- Excessive vascular tortuosity or anatomical variants that may preclude successful delivery or positioning of interventional devices.
- History of contraindication to the use of contrast medium.
- Refractory hypertension (defined as systolic blood pressure>185 mmHg or diastolic blood pressure>110 mmHg) that cannot be controlled by drug treatment.
- Known hereditary or acquired bleeding tendency, lack of coagulation factors, or oral anticoagulants with INR>1.5.
- Blood glucose<2.8 or>22.2 mmol/L; Platelet count<100*109/L, serum creatinine>2.0 g/L (177 μ mol/L), or glomerular filtration rate<30 ml/(min*1.73 m2).
- Concurrent participation in another drug or device trial, or expected participation within the following 3 months.
- Patients whose life expectancy is less than 1 year (such as patients with malignant tumor, advanced cardiopulmonary disease, etc.).
- Known pregnancy or lactation, or positive pregnancy test before randomization (or before enrollment).
- Known dementia or psychiatric disorder that precludes completion of neurological assessments and follow-up.
- Any other condition deemed by the site investigator to make the patient unsuitable for participation.
Plan de estudios
¿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 |
|---|---|
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Experimental: Intervention group
Bailout Angioplasty or Stenting (BAOS) Group
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Balloon angioplasty and/or stent placement for residual severe stenosis (≥70%) after successful thrombectomy; combined with medical management (intravenous tirofiban, followed by dual antiplatelet therapy with aspirin 100 mg/day and clopidogrel 75 mg/day for 90 days, then single antiplatelet therapy thereafter; and cerebrovascular risk factor management).
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Otro: Control group
Standard Ttherapy Group
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Endovascular thrombectomy performed according to guideline recommendations, without additional endovascular intervention; combined with medical management (intravenous tirofiban as needed, dual antiplatelet therapy with aspirin 100 mg/day and clopidogrel 75 mg/day for 90 days, then single antiplatelet therapy thereafter; and cerebrovascular risk factor management).
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
The primary endpoint is the mRS score at 90 (±7) days after randomization (or after enrollment), analyzed as an ordinal variable
Periodo de tiempo: 90±7 days after randomization (or after enrollment)
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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.
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90±7 days after randomization (or after enrollment)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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The proportion of mRS 0-1, 0-2 and 0-3 at 90 (±7) days
Periodo de tiempo: 90±7 days after randomization (or after enrollment)
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The proportion of mRS 0-1, 0-2 and 0-3 at 90 (±7) days.
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90±7 days after randomization (or after enrollment)
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The rate of stroke recurrence in the target vessel territory within 90 (±7) days
Periodo de tiempo: 90±7 days after randomization (or after enrollment)
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Stroke recurrence in the target vessel territory within 90 (±7) days.
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90±7 days after randomization (or after enrollment)
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NIHSS score at 24 (±6/+12) hours
Periodo de tiempo: 24 (-6/+12) hours after randomization (or after enrollment)
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The National Institute of Health Stroke Scale (NIHSS) ranged from 0 to 42, with higher scores indicating greater neurologic deficits.
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24 (-6/+12) hours after randomization (or after enrollment)
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European Five Dimensional Health Scale Level 5 (EQ-5D-5L) score at 90±7 days
Periodo de tiempo: 90±7 days after randomization (or after enrollment)
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EuroQol Five Dimensions (EQ-5D-5L) is a standardized instrument for measuring the general health status.
Rated level can be coded as a number 1, 2, 3, 4 or 5, which indicates having no problems for 1, having some problems for 2, having moderate problems for 3, having serious problems for 4 and having extreme problems for 5.
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90±7 days after randomization (or after enrollment)
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Patency of the target vessel at 24 (±6/+12) hours after the procedure, as confirmed by CTA, MRA, DSA, or TCD
Periodo de tiempo: 24 (-6/+12) hours after randomization (or after enrollment)
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Patency of the target vessel at 24 (±6/+12) hours after the procedure, as confirmed by CTA, MRA, DSA, or TCD.
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24 (-6/+12) hours after randomization (or after enrollment)
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The mRS score at 1 year (±30 days), analyzed as an ordinal variable
Periodo de tiempo: 1 year (±30 days) after randomization (or after enrollment)
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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.
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1 year (±30 days) after randomization (or after enrollment)
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The proportion of mRS 0-1, 0-2 and 0-3 scores at 1 year (± 30 days)
Periodo de tiempo: 1 year (±30 days) after randomization (or after enrollment)
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The proportion of mRS 0-1, 0-2 and 0-3 scores at 1 year (± 30 days).
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1 year (±30 days) after randomization (or after enrollment)
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The rate of stroke recurrence in the target vessel territory within 1 year (± 30 days)
Periodo de tiempo: 1 year (±30 days) after randomization (or after enrollment)
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Stroke recurrence in the target vessel territory within 1 year (± 30 days).
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1 year (±30 days) after randomization (or after enrollment)
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Patency of the target vessel at 1 year (± 30 days) after the procedure, as confirmed by CTA, MRA, DSA, or TCD
Periodo de tiempo: 1 year (±30 days) after randomization (or after enrollment)
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Patency of the target vessel at 1 year (± 30 days) after the procedure, as confirmed by CTA, MRA, DSA, or TCD.
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1 year (±30 days) after randomization (or after enrollment)
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European Five Dimensional Health Scale Level 5 (EQ-5D-5L) score at 1 year (±30 days)
Periodo de tiempo: 1 year (±30 days) after randomization (or after enrollment)
|
EuroQol Five Dimensions (EQ-5D-5L) is a standardized instrument for measuring the general health status.
Rated level can be coded as a number 1, 2, 3, 4 or 5, which indicates having no problems for 1, having some problems for 2, having moderate problems for 3, having serious problems for 4 and having extreme problems for 5.
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1 year (±30 days) after randomization (or after enrollment)
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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The rate of any Symptomatic intracranial hemorrhage (sICH) defined as the Heidelberg classification within 24 hours
Periodo de tiempo: 24 (-6/+12) hours after randomization (or after enrollment)
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Heidelberg standard was defined as new intracranial hemorrhage detected by brain imaging associated with any of the item below: 4 points total NIHSS at the time of diagnosis compared to immediately before worsening.
2 point in one NIHSS category.
Leading to intubation/hemicraniectomy/ventricular drainage placement or other major medical/surgical intervention.
Absence of alternative explanation for deterioration.
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24 (-6/+12) hours after randomization (or after enrollment)
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The rate of all-cause mortality within 90 days
Periodo de tiempo: 90±7 days after randomization (or after enrollment)
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All cause of mortality within 90 days.
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90±7 days after randomization (or after enrollment)
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The rate of any intracranial hemorrhage identified by CT or MRI imaging within 24 hours after randomization
Periodo de tiempo: 24 (-6/+12) hours after randomization
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Any intracranial hemorrhage identified by CT or MRI imaging within 24 (-6/+12) hours after randomization.
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24 (-6/+12) hours after randomization
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Procedure-related complications, including arterial perforation, arterial dissection, and embolization to a new vascular territory
Periodo de tiempo: At the end of the procedure or intraoperatively
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Procedure-related complications, including arterial perforation, arterial dissection, and embolization to a new vascular territory.
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At the end of the procedure or intraoperatively
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Procedure-related complications: arterial perforation, arterial dissection, and new territorial embolism, etc
Periodo de tiempo: At the end of the procedure or intraprocedurally
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Procedure-related complications: arterial perforation, arterial dissection, and new territorial embolism, etc.
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At the end of the procedure or intraprocedurally
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The rate of all-cause mortality within 1 year (± 30 days)
Periodo de tiempo: 1 year (±30 days) after randomization (or after enrollment)
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The rate of all-cause mortality within 1 year (±30 days).
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1 year (±30 days) after randomization (or after enrollment)
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The rate of any Symptomatic intracranial hemorrhage (sICH) defined as the Heidelberg classification or any intracranial hemorrhage within 1 year (±30 days)
Periodo de tiempo: 1 year (±30 days) after randomization (±30 days)
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Any Symptomatic intracranial hemorrhage (sICH) defined as the Heidelberg classification or any intracranial hemorrhage within 1 year (±30 days).
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1 year (±30 days) after randomization (±30 days)
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Feng Gao, MD, Beijing Tiantan Hospital
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- HX-A-2026023
Plan de datos de participantes individuales (IPD)
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Información sobre medicamentos y dispositivos, documentos del estudio
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