- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07574645
Spinal Dural Arteriovenous Fistula International Data and Outcomes Registry (SPIDER)
SPIDER - Spinal Dural Arteriovenous Fistula International Data and Outcomes Registry
연구 개요
상태
상세 설명
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.
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Pascal Jabbour, MD
- 전화번호: 215-955-7000
- 이메일: pascal.jabbour@jefferson.edu
연구 장소
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Pennsylvania
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Philadelphia, Pennsylvania, 미국, 19102
- 모병
- Thomas Jefferson University Hospital
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연락하다:
- Victor Gabriel El-Hajj, MD
- 전화번호: 215-955-7000
- 이메일: victorgabriel.el-hajj2@jefferson.edu
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-
참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Type 1 spinal dural arteriovenous fistula, confirmed on imaging
- Surgically or endovascularly treated
- At least 1 available primary outcome
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Treatment success
기간: 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
기간: 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
기간: 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.
|
|
Modified Aminoff-Logue Scale
기간: 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
기간: 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
|
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
기간: 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.
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- SPIDER iRISID-2026-0174
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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