Spinal Dural Arteriovenous Fistula International Data and Outcomes Registry (SPIDER)
SPIDER - Spinal Dural Arteriovenous Fistula International Data and Outcomes Registry
Descripción general del estudio
Estado
Condiciones
Descripción detallada
Type 1 or dural spinal arteriovenous fistulas (SDAVFs) are the most common spinal vascular malformation but remain frequently underdiagnosed due to their insidious onset and nonspecific clinical presentation. Delayed diagnosis is common and often results in progressive, and sometimes irreversible, myelopathy. Despite advances in imaging and treatment, there remains significant variability in diagnostic timelines, treatment strategies (endovascular, surgical, or combined), and reported outcomes across institutions.
Existing literature is largely limited to single-center retrospective series or small cohorts, often underpowered to evaluate predictors of outcome, recurrence, and the impact of diagnostic delay. Furthermore, direct comparisons between treatment modalities and long-term functional outcomes using standardized clinical scales are limited.
The SPIDER registry is designed to address these gaps by creating the largest international, multicenter dataset of patients with spinal dural AVFs. By pooling de-identified data from high-volume centers worldwide, this study aims to provide robust, generalizable evidence to inform clinical decision-making and optimize patient outcomes.
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Pascal Jabbour, MD
- Número de teléfono: 215-955-7000
- Correo electrónico: pascal.jabbour@jefferson.edu
Ubicaciones de estudio
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Pennsylvania
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Philadelphia, Pennsylvania, Estados Unidos, 19102
- Reclutamiento
- Thomas Jefferson University Hospital
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Contacto:
- Victor Gabriel El-Hajj, MD
- Número de teléfono: 215-955-7000
- Correo electrónico: victorgabriel.el-hajj2@jefferson.edu
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Type 1 spinal dural arteriovenous fistula, confirmed on imaging
- Surgically or endovascularly treated
- At least 1 available primary outcome
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Treatment success
Periodo de tiempo: Recorded at the end of the embolization or surgery.
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Complete surgical/endovascular obliteration of the fistula
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Recorded at the end of the embolization or surgery.
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Recurrence
Periodo de tiempo: Time-to-event Outcome Measures. Estimated period of time over which the event is assessed: on average 1.5 years after surgery.
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Fistula recurrence
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Time-to-event Outcome Measures. Estimated period of time over which the event is assessed: on average 1.5 years after surgery.
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Status of symptoms at last clinical follow-up
Periodo de tiempo: Time-to-event Outcome Measures. Estimated period of time over which the event is assessed: on average 1.5 years after surgery.
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Improved, unchanged, or worsened pain, sensory, and motor symptoms
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Time-to-event Outcome Measures. Estimated period of time over which the event is assessed: on average 1.5 years after surgery.
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Modified Aminoff-Logue Scale
Periodo de tiempo: Time-to-event Outcome Measures. Estimated period of time over which the event is assessed: on average 1.5 years after surgery.
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Gait and bowel/bladder score
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Time-to-event Outcome Measures. Estimated period of time over which the event is assessed: on average 1.5 years after surgery.
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Modified Rankin Scale
Periodo de tiempo: Time-to-event Outcome Measures. Estimated period of time over which the event is assessed: on average 1.5 years after surgery.
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Measure of functional independence
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Time-to-event Outcome Measures. Estimated period of time over which the event is assessed: on average 1.5 years after surgery.
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Mortality
Periodo de tiempo: Time-to-event Outcome Measures. Estimated period of time over which the event is assessed: on average 1.5 years after surgery.
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Time-to-event Outcome Measures. Estimated period of time over which the event is assessed: on average 1.5 years after surgery.
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
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
Otros números de identificación del estudio
- SPIDER iRISID-2026-0174
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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