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

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

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07604688

Acronym

DREAM

Enrollment

10050

Registered

2026-05-22

Start date

2026-05-18

Completion date

2030-02-28

Last updated

2026-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intracranial Dural Arteriovenous Fistula

Keywords

intracranial dural arteriovenous fistula, fistula, malforamtion, outcome

Brief summary

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

PROCEDUREendovascular

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.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Improvement in modified Rankin Scale (mRS) score at 6 months after treatment	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.

Secondary

Measure	Time frame	Description
Angiographic obliteration and recurrence rates at 6 months after treatment	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.
Improvement in modified Rankin Scale (mRS) score at 12 months after treatment	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.

Countries

China

Contacts

CONTACTXin Su, M.D

1258940078@qq.com86-18210685023

CONTACTYongjie Ma, M.D

1258940078@qq.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 23, 2026