An observational study in Intracranial Dural Arteriovenous Fistula, sponsored by Xuanwu Hospital, Beijing. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-04.
Sponsored by Xuanwu Hospital, Beijing · Observational
This multicenter registry study aims to clarify the incidence trends of intracranial dural arteriovenous fistulas (IDAVF) and spinal dural arteriovenous fistulas (SDAVF) in China, evaluate current treatment patterns, and establish a nationwide multicenter retrospective and prospective database. The study is designed as a multicenter retrospective and prospective observational study involving more than 60 core hospitals across seven major geographic regions of China. The retrospective phase will include patients diagnosed between February 28, 2015 and February 28, 2025, while the prospective phase will enroll patients from March 1, 2025 to March 1, 2030. Eligible participants are patients diagnosed with IDAVF or SDAVF by digital subtraction angiography (DSA). The study will analyze disease incidence and temporal trends, collect baseline demographic and clinical characteristics, and evaluate treatment outcomes including obliteration rate, recurrence rate, and clinical prognosis. The crude incidence rate per 100,000 person-years during the study period will also be calculated based on Chinese census population data. The primary endpoint is the improvement rate in modified Rankin Scale (mRS) score at 6 months after treatment. Secondary endpoints include obliteration and recurrence rates on imaging follow-up at 6 months and improvement in mRS score at 12 months after treatment. Statistical analyses will be performed using SAS 9.4 software, including descriptive analyses as well as univariate and multivariate regression analyses to identify factors associated with clinical outcomes and prognosis.
The study population consists of patients diagnosed with intracranial dural arteriovenous fistulas (IDAVF) or spinal dural arteriovenous fistulas (SDAVF) at more than 60 participating centers across seven geographic regions of China. Both retrospective and prospective cohorts will be included. Eligible patients will be identified based on digital subtraction angiography (DSA)-confirmed diagnosis and available clinical and imaging data.
Exclusion Criteria:
This is a multicenter retrospective and prospective observational registry study of patients with intracranial dural arteriovenous fistulas (IDAVF) and spinal dural arteriovenous fistulas (SDAVF) in China. No experimental intervention will be assigned as part of the study. Diagnosis, treatment selection, and follow-up will be performed according to routine clinical practice at each participating center, including microsurgery, endovascular embolization, radiosurgery, conservative management, or combined treatment strategies when applicable. The study will collect demographic, clinical, angiographic, treatment, and follow-up outcome data to evaluate epidemiology, treatment patterns, obliteration rates, recurrence, and functional outcomes in a real-world multicenter cohort.
Improvement in modified Rankin Scale (mRS) score at 6 months after treatment
The primary outcome measure is the proportion of patients demonstrating improvement in neurological functional status, as assessed by the modified Rankin Scale (mRS), at 6 months after treatment. Clinical outcomes will be evaluated through outpatient or telephone follow-up.
Time frame: 6 months after treatment
Angiographic obliteration and recurrence rates at 6 months after treatment
The secondary outcome measure includes angiographic obliteration and recurrence rates of intracranial or spinal dural arteriovenous fistulas at 6 months after treatment, as assessed by follow-up DSA, CTA, or MRA when available.
Time frame: 6 months after treatment
Improvement in modified Rankin Scale (mRS) score at 12 months after treatment
The secondary outcome measure is the proportion of patients demonstrating improvement in neurological functional status, as assessed by the modified Rankin Scale (mRS), at 12 months after treatment. Clinical outcomes will be evaluated through outpatient or telephone follow-up.
Time frame: 12 months after treatment
Plan to share: Yes
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Xuanwu Hospital, Beijing