NCT07604688

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10,050

participants targeted

Target at P75+ for all trials

Timeline
45mo left

Started May 2026

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress2%
May 2026Feb 2030

First Submitted

Initial submission to the registry

May 18, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

May 18, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 22, 2026

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2030

Last Updated

June 4, 2026

Status Verified

June 1, 2026

Enrollment Period

3.8 years

First QC Date

May 18, 2026

Last Update Submit

June 2, 2026

Conditions

Intracranial Dural Arteriovenous Fistula

Keywords

intracranial dural arteriovenous fistulafistulamalforamtionoutcome

Outcome Measures

Primary Outcomes (1)

  • 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.

    6 months after treatment

Secondary Outcomes (2)

  • Angiographic obliteration and recurrence rates at 6 months after treatment

    6 months after treatment

  • Improvement in modified Rankin Scale (mRS) score at 12 months after treatment

    12 months after treatment

Interventions

endovascularPROCEDURE

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xuanwu Hospital

Beijing, 100053, China

RECRUITING

Related Publications (1)

  • 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: 39922696RESULT

MeSH Terms

Conditions

Fistula

Condition Hierarchy (Ancestors)

Pathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Central Study Contacts

Xin Su, M.D

CONTACT

86-182106850231258940078@qq.com

Yongjie Ma, M.D

CONTACT

1258940078@qq.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 18, 2026

First Posted

May 22, 2026

Study Start

May 18, 2026

Primary Completion (Estimated)

February 28, 2030

Study Completion (Estimated)

February 28, 2030

Last Updated

June 4, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will share

Locations

CN(1)