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Spinal Dural Arteriovenous Fistula International Data and Outcomes Registry (SPIDER)

4. maj 2026 opdateret af: Pascal Jabboour, Thomas Jefferson University

SPIDER - Spinal Dural Arteriovenous Fistula International Data and Outcomes Registry

Given the lack of large multicenter datasets in the context of Spinal arteriovenous fistula, the strength of the evidence surrounding this rare disease is limited. SPIDER hence aims to address that by compiling patient-level data from centers all around the world.

Studieoversigt

Status

Rekruttering

Betingelser

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Anslået)

1000

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

The registry will include patients from 40 different hospitals in 20 different countries.

Beskrivelse

Inclusion Criteria:

  • Type 1 spinal dural arteriovenous fistula, confirmed on imaging
  • Surgically or endovascularly treated
  • At least 1 available primary outcome

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Treatment success
Tidsramme: Recorded at the end of the embolization or surgery.
Complete surgical/endovascular obliteration of the fistula
Recorded at the end of the embolization or surgery.
Recurrence
Tidsramme: Time-to-event Outcome Measures. Estimated period of time over which the event is assessed: on average 1.5 years after surgery.
Fistula recurrence
Time-to-event Outcome Measures. Estimated period of time over which the event is assessed: on average 1.5 years after surgery.
Status of symptoms at last clinical follow-up
Tidsramme: Time-to-event Outcome Measures. Estimated period of time over which the event is assessed: on average 1.5 years after surgery.
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.
Modified Aminoff-Logue Scale
Tidsramme: Time-to-event Outcome Measures. Estimated period of time over which the event is assessed: on average 1.5 years after surgery.
Gait and bowel/bladder score
Time-to-event Outcome Measures. Estimated period of time over which the event is assessed: on average 1.5 years after surgery.
Modified Rankin Scale
Tidsramme: Time-to-event Outcome Measures. Estimated period of time over which the event is assessed: on average 1.5 years after surgery.
Measure of functional independence
Time-to-event Outcome Measures. Estimated period of time over which the event is assessed: on average 1.5 years after surgery.
Mortality
Tidsramme: Time-to-event Outcome Measures. Estimated period of time over which the event is assessed: on average 1.5 years after surgery.
Time-to-event Outcome Measures. Estimated period of time over which the event is assessed: on average 1.5 years after surgery.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Thomas Jefferson University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

5. januar 2026

Primær færdiggørelse (Anslået)

1. maj 2026

Studieafslutning (Anslået)

1. maj 2026

Datoer for studieregistrering

Først indsendt

22. april 2026

Først indsendt, der opfyldte QC-kriterier

4. maj 2026

Først opslået (Faktiske)

8. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

8. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

4. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • SPIDER iRISID-2026-0174

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

Data cannot be shared due to its multicenter nature.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Spinal Dural Arteriovenous Fistula

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Pakistan

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner