Menu
Recruiting NCT07604688

Multicenter Registry Study of Patients With Intracranial Dural Arteriovenous Fistulas in China

— Observational Intracranial Dural Arteriovenous Fistula

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: endovascular.
Who it may be relevant to
Registry conditions: Intracranial Dural Arteriovenous Fistula. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Dural Arteriovenous Fistulas Registry, Evaluation, and Management Study in China (DREAM)

Overview

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.

Interventions

  • Procedure endovascular
    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

Primary outcome measures

  • Improvement in modified Rankin Scale (mRS) score at 6 months after treatment [Time frame: 6 months after treatment]
Secondary outcome measures (2)
  • Angiographic obliteration and recurrence rates at 6 months after treatment [Time frame: 6 months after treatment]
  • Improvement in modified Rankin Scale (mRS) score at 12 months after treatment [Time frame: 12 months after treatment]

Eligibility criteria

Inclusion criteria

  • Patients diagnosed with intracranial dural arteriovenous fistula (IDAVF) or spinal dural arteriovenous fistula (SDAVF) by cerebral or spinal digital subtraction angiography (DSA)
  • Patients treated or evaluated at participating centers during the study period
  • Availability of complete clinical and imaging records, including baseline information, treatment records, and DSA images
  • For the prospective cohort, written informed consent signed by the patient or legal representative

Exclusion criteria

  • Patients with facial or scalp arteriovenous fistulas
  • Patients with non-dural vascular malformations or non-arteriovenous fistula vascular diseases, including cavernous malformations or venous malformations

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Xuanwu Hospital — Beijing

Publications

  • Su X, Ma Y, Song Z, Liu H, Zhang C, Pang H, Chen Y, Zhao B, Huang M, Sun L, Hu P, Li G, Hong T, Ye M, Zhang H, Zhang P. Dural arteriovenous fistula research and management in China (DREAM-INI): initial characterization and patient cohort outcomes. J Neurointerv Surg. 2026 Jan 13;18(2):332-338. doi: 10.1136/jnis-2024-023014. PMID 39922696

Identifiers

NCT: NCT07604688 · zpmyjsx930826

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗