Multicenter Registry Study of Patients With Intracranial Dural Arteriovenous Fistulas in China
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorXuanwu Hospital, Beijing
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- endovascular
Treatment groups
No treatment groups listed
Sponsors and collaborators
Xuanwu Hospital, Beijing
Lead sponsor
Army Medical Center of PLA
Collaborator
The Second Hospital of Hebei Medical University
Collaborator
Shanghai Donglei Brain Hospital
Collaborator
Peking University International Hospital
Collaborator
The Second Affiliated Hospital of Chongqing Medical University
Collaborator
Henan Provincial People's Hospital
Collaborator
The Second Affiliated Hospital of Kunming Medical University
Collaborator
Deyang People's Hospital
Collaborator
Shandong Second Provincial People's Hospital (Shandong Provincial ENT Hospital)
Collaborator
Nanfang Hospital, Southern Medical University
Collaborator
Lanzhou University Second Hospital
Collaborator
First Hospital of China Medical University
Collaborator
South China Hospital Affiliated to Shenzhen University
Collaborator
Zhejiang University
Collaborator
Guangdong Provincial Hospital of Traditional Chinese Medicine
Collaborator
Seventh Medical Center of PLA Army General Hospital
Collaborator
Peking University Third Hospital
Collaborator
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Collaborator
The First Affiliated Hospital of Dalian Medical University
Collaborator
The First Hospital of Hebei Medical University
Collaborator
Third Affiliated Hospital, Sun Yat-Sen University
Collaborator
First Affiliated Hospital of Fujian Medical University
Collaborator
Tianjin Huanhu Hospital
Collaborator
Shandong Provincial Hospital
Collaborator
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Collaborator
The First Affiliated Hospital of Nanchang University
Collaborator
The Second Affiliated Hospital of Air Force Medical University (Tangdu Hospital)
Collaborator
Linyi People's Hospital
Collaborator
The First Hospital of Jilin University
Collaborator
First Affiliated Hospital of Wenzhou Medical University
Collaborator
Guangdong Provincial People's Hospital
Collaborator
Zhongshan Hospital Affiliated to Xiamen University
Collaborator
Jiangsu Province Hospital (Department of Interventional Radiology)
Collaborator
Jining First People's Hospital
Collaborator
Fudan University
Collaborator
Department of Neurosurgery and Junshan Brain Center, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Collaborator
The First Affiliated Hospital of Shanxi Medical University
Collaborator
The First Affiliated Hospital of Hainan Medical University
Collaborator
First Affiliated Hospital of Xinjiang Medical University
Collaborator
The Central Hospital of Enshi Tujia And Miao Autonomous Prefecture
Collaborator
The First Affiliated Hospital of USTC (Anhui Provincial Hospital)
Collaborator
The First Affiliated Hospital of Anhui Medical University
Collaborator
The First Affiliated Hospital of Army Medical University (Southwest Hospital)
Collaborator
Gansu Provincial Hospital
Collaborator
The First Affiliated Hospital of Air Force Medical University (Xijing Hospital)
Collaborator
Baotou Central Hospital
Collaborator
The Affiliated Hospital of Inner Mongolia Medical University
Collaborator
Second Affiliated Hospital of Nanchang University
Collaborator
Queen Elizabeth Hospital, Hong Kong Special Administrative Region
Collaborator
Zhujiang Hospital
Collaborator
Ganzhou People's Hospital, Jiangxi Province
Collaborator
Affiliated Hospital of Shandong Second Medical University
Collaborator
Qilu Hospital of Shandong University
Collaborator
Guangdong Second Provincial General Hospital
Collaborator
Sichuan Provincial People's Hospital
Collaborator
Fujian Provincial Hospital Affiliated to Fuzhou University
Collaborator
General Hospital of Eastern Theater Command, Chinese People's Liberation Army
Collaborator
The First Affiliated Hospital of Zhengzhou University
Collaborator
Second Affiliated Hospital of Xi'an Jiaotong University
Collaborator
Guangxi Hospital of the First Affiliated Hospital, Sun Yat-sen University
Collaborator
Liaoning Provincial People's Hospital
Collaborator
The Affiliated Hospital of Qingdao University
Collaborator
The First Affiliated Hospital with Nanjing Medical University
Collaborator
West China Hospital
Collaborator
Tianjin Medical University General Hospital
Collaborator
The Third Medical Center of PLA General Hospital (Former General Hospital of the Chinese People's Armed Police Forces)
Collaborator
Peking Union Medical College Hospital
Collaborator
First Affiliated Hospital of Harbin Medical University
Collaborator
Wuhan Central Hospital
Collaborator
First Affiliated Hospital of Jinan University
Collaborator
First Affiliated Hospital Xi'an Jiaotong University
Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborator
Yichang Central People's Hospital
Collaborator
Huashan Hospital
Collaborator
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Collaborator
Peking University First Hospital
Collaborator
Beijing Haidian Hospital
Collaborator
Source ClinicalTrials.gov