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

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.

NCT Number	NCT07604688
Lead Sponsor	Xuanwu Hospital, Beijing Collaborators: Army Medical Center of PLA, The Second Hospital of Hebei Medical University, Shanghai Donglei Brain Hospital, Peking University International Hospital, The Second Affiliated Hospital of Chongqing Medical University, Henan Provincial People's Hospital, The Second Affiliated Hospital of Kunming Medical University, Deyang People's Hospital, Shandong Provincial Hospital, Nanfang Hospital, Southern Medical University, Lanzhou University Second Hospital, First Hospital of China Medical University, South China Hospital Affiliated to Shenzhen University, Zhejiang University, Guangdong Provincial Hospital of Traditional Chinese Medicine, Seventh Medical Center of PLA Army General Hospital, Peking University Third Hospital, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, The First Affiliated Hospital of Dalian Medical University, The First Hospital of Hebei Medical University, Third Affiliated Hospital, Sun Yat-Sen University, First Affiliated Hospital of Fujian Medical University, Tianjin Huanhu Hospital, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, The First Affiliated Hospital of Nanchang University, The Second Affiliated Hospital of Air Force Military Medical University, Linyi People's Hospital, The First Hospital of Jilin University, First Affiliated Hospital of Wenzhou Medical University, Guangdong Provincial People's Hospital, Zhongshan Hospital Affiliated to Xiamen University, Jiangsu Province Hospital (Department of Interventional Radiology), Jining First People's Hospital, Fudan University, Department of Neurosurgery and Junshan Brain Center, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, The First Affiliated Hospital of Shanxi Medical University, The First Affiliated Hospital of Hainan Medical University, First Affiliated Hospital of Xinjiang Medical University, The Central Hospital of Enshi Tujia And Miao Autonomous Prefecture, The First Affiliated Hospital of China University of Science and Technology (Anhui Provincial), The First Affiliated Hospital of Anhui Medical University, The First Affiliated Hospital of Army Medical University (Southwest Hospital), Gansu Provincial Hospital, The First Affiliated Hospital of Air Force Medicial University, Baotou Central Hospital, The Affiliated Hospital of Inner Mongolia Medical University, Second Affiliated Hospital of Nanchang University, Queen Elizabeth Hospital, Hong Kong Special Administrative Region, Zhujiang Hospital, Ganzhou People's Hospital, Jiangxi Province, Affiliated Hospital of Shandong Second Medical University, Qilu Hospital of Shandong University, Guangdong Second Provincial General Hospital, Sichuan Provincial People's Hospital, Fujian Provincial Hospital Affiliated to Fuzhou University, General Hospital of Eastern Theater Command, Chinese People's Liberation Army, The First Affiliated Hospital of Zhengzhou University, Second Affiliated Hospital of Xi'an Jiaotong University, Guangxi Hospital of the First Affiliated Hospital, Sun Yat-sen University, Liaoning Provincial People's Hospital, The Affiliated Hospital of Qingdao University, The First Affiliated Hospital with Nanjing Medical University, West China Hospital, Tianjin Medical University General Hospital, The Third Medical Center of PLA General Hospital (Former General Hospital of the Chinese People's Armed Police Forces), Peking Union Medical College Hospital, First Affiliated Hospital of Harbin Medical University, Wuhan Central Hospital, First Affiliated Hospital of Jinan University, First Affiliated Hospital Xi'an Jiaotong University, Second Affiliated Hospital, Zhejiang University, School of Medicine, Yichang Central People's Hospital, Huashan Hospital, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Peking University First Hospital, Beijing Haidian Hospital
Conditions	Intracranial Dural Arteriovenous Fistula
Enrollment	10,050 participants
Start Date	2026-05-18
Primary Completion	2030-02-28 (estimated)
Study Completion	2030-02-28 (estimated)
Updated on ClinicalTrials.gov	2026-06-04