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

NCT07604688 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 10050

Last updated 2026-05-22

No results posted yet for this study

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.

Conditions

  • Intracranial Dural Arteriovenous Fistula

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 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.

Sponsors & Collaborators

  • Army Medical Center of PLA

    collaborator OTHER_GOV
  • The Second Hospital of Hebei Medical University

    collaborator OTHER
  • Shanghai Donglei Brain Hospital

    collaborator UNKNOWN
  • Peking University International Hospital

    collaborator OTHER
  • The Second Affiliated Hospital of Chongqing Medical University

    collaborator OTHER
  • Henan Provincial People's Hospital

    collaborator OTHER
  • The Second Affiliated Hospital of Kunming Medical University

    collaborator OTHER
  • Deyang People's Hospital

    collaborator OTHER
  • Shandong Second Provincial People's Hospital (Shandong Provincial ENT Hospital)

    collaborator UNKNOWN
  • Nanfang Hospital, Southern Medical University

    collaborator OTHER
  • Lanzhou University Second Hospital

    collaborator OTHER
  • First Hospital of China Medical University

    collaborator OTHER
  • South China Hospital Affiliated to Shenzhen University

    collaborator UNKNOWN
  • Zhejiang University

    collaborator OTHER
  • Guangdong Provincial Hospital of Traditional Chinese Medicine

    collaborator OTHER
  • Seventh Medical Center of PLA Army General Hospital

    collaborator OTHER
  • Peking University Third Hospital

    collaborator OTHER
  • Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

    collaborator OTHER
  • The First Affiliated Hospital of Dalian Medical University

    collaborator OTHER
  • The First Hospital of Hebei Medical University

    collaborator OTHER
  • Third Affiliated Hospital, Sun Yat-Sen University

    collaborator OTHER
  • First Affiliated Hospital of Fujian Medical University

    collaborator OTHER
  • Tianjin Huanhu Hospital

    collaborator OTHER
  • Shandong Provincial Hospital

    collaborator OTHER_GOV
  • The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

    collaborator OTHER
  • The First Affiliated Hospital of Nanchang University

    collaborator OTHER
  • The Second Affiliated Hospital of Air Force Medical University (Tangdu Hospital)

    collaborator UNKNOWN
  • Linyi People's Hospital

    collaborator OTHER
  • The First Hospital of Jilin University

    collaborator OTHER
  • First Affiliated Hospital of Wenzhou Medical University

    collaborator OTHER
  • Guangdong Provincial People's Hospital

    collaborator OTHER
  • Zhongshan Hospital Affiliated to Xiamen University

    collaborator UNKNOWN
  • Jiangsu Province Hospital (Department of Interventional Radiology)

    collaborator UNKNOWN
  • Jining First People's Hospital

    collaborator OTHER
  • Fudan University

    collaborator OTHER
  • Department of Neurosurgery and Junshan Brain Center, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

    collaborator UNKNOWN
  • The First Affiliated Hospital of Shanxi Medical University

    collaborator OTHER
  • The First Affiliated Hospital of Hainan Medical University

    collaborator OTHER_GOV
  • First Affiliated Hospital of Xinjiang Medical University

    collaborator OTHER
  • The Central Hospital of Enshi Tujia And Miao Autonomous Prefecture

    collaborator OTHER
  • The First Affiliated Hospital of USTC (Anhui Provincial Hospital)

    collaborator UNKNOWN
  • The First Affiliated Hospital of Anhui Medical University

    collaborator OTHER
  • The First Affiliated Hospital of Army Medical University (Southwest Hospital)

    collaborator UNKNOWN
  • Gansu Provincial Hospital

    collaborator OTHER
  • The First Affiliated Hospital of Air Force Medical University (Xijing Hospital)

    collaborator UNKNOWN
  • Baotou Central Hospital

    collaborator OTHER
  • The Affiliated Hospital of Inner Mongolia Medical University

    collaborator OTHER
  • Second Affiliated Hospital of Nanchang University

    collaborator OTHER
  • Queen Elizabeth Hospital, Hong Kong Special Administrative Region

    collaborator UNKNOWN
  • Zhujiang Hospital

    collaborator OTHER
  • Ganzhou People's Hospital, Jiangxi Province

    collaborator UNKNOWN
  • Affiliated Hospital of Shandong Second Medical University

    collaborator UNKNOWN
  • Qilu Hospital of Shandong University

    collaborator OTHER
  • Guangdong Second Provincial General Hospital

    collaborator OTHER
  • Sichuan Provincial People's Hospital

    collaborator OTHER
  • Fujian Provincial Hospital Affiliated to Fuzhou University

    collaborator UNKNOWN
  • General Hospital of Eastern Theater Command, Chinese People's Liberation Army

    collaborator UNKNOWN
  • The First Affiliated Hospital of Zhengzhou University

    collaborator OTHER
  • Second Affiliated Hospital of Xi'an Jiaotong University

    collaborator OTHER
  • Guangxi Hospital of the First Affiliated Hospital, Sun Yat-sen University

    collaborator UNKNOWN
  • Liaoning Provincial People's Hospital

    collaborator UNKNOWN
  • The Affiliated Hospital of Qingdao University

    collaborator OTHER
  • The First Affiliated Hospital with Nanjing Medical University

    collaborator OTHER
  • West China Hospital

    collaborator OTHER
  • Tianjin Medical University General Hospital

    collaborator OTHER
  • The Third Medical Center of PLA General Hospital (Former General Hospital of the Chinese People's Armed Police Forces)

    collaborator UNKNOWN
  • Peking Union Medical College Hospital

    collaborator OTHER
  • First Affiliated Hospital of Harbin Medical University

    collaborator OTHER
  • Wuhan Central Hospital

    collaborator OTHER
  • First Affiliated Hospital of Jinan University

    collaborator OTHER
  • First Affiliated Hospital Xi'an Jiaotong University

    collaborator OTHER
  • Second Affiliated Hospital, School of Medicine, Zhejiang University

    collaborator OTHER
  • Yichang Central People's Hospital

    collaborator OTHER
  • Huashan Hospital

    collaborator OTHER
  • Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

    collaborator OTHER
  • Peking University First Hospital

    collaborator OTHER
  • Beijing Haidian Hospital

    collaborator OTHER
  • Xuanwu Hospital, Beijing

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-18
Primary Completion
2030-02-28
Completion
2030-02-28

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07604688 on ClinicalTrials.gov