Spinal Dural Arteriovenous Fistula International Data and Outcomes Registry (SPIDER)
SPIDER - Spinal Dural Arteriovenous Fistula International Data and Outcomes Registry
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
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 di studio
Iscrizione (Stimato)
Contatti e Sedi
Contatto studio
- Nome: Pascal Jabbour, MD
- Numero di telefono: 215-955-7000
- Email: pascal.jabbour@jefferson.edu
Luoghi di studio
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Pennsylvania
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Philadelphia, Pennsylvania, Stati Uniti, 19102
- Reclutamento
- Thomas Jefferson University Hospital
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Contatto:
- Victor Gabriel El-Hajj, MD
- Numero di telefono: 215-955-7000
- Email: victorgabriel.el-hajj2@jefferson.edu
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Bambino
- Adulto
- Adulto più anziano
Accetta volontari sani
Metodo di campionamento
Popolazione di studio
Descrizione
Inclusion Criteria:
- Type 1 spinal dural arteriovenous fistula, confirmed on imaging
- Surgically or endovascularly treated
- At least 1 available primary outcome
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Treatment success
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
|
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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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.
|
Collaboratori e investigatori
Sponsor
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- SPIDER iRISID-2026-0174
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano IPD
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .