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

June 2, 2026 updated by: Xuanwu Hospital, Beijing

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10050

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
      • Beijing, China, 100053
        • Recruiting
        • Xuanwu Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Improvement in modified Rankin Scale (mRS) score at 6 months after treatment
Time Frame: 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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Angiographic obliteration and recurrence rates at 6 months after treatment
Time Frame: 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.
6 months after treatment
Improvement in modified Rankin Scale (mRS) score at 12 months after treatment
Time Frame: 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.
12 months after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Xuanwu Hospital, Beijing

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
The First Affiliated Hospital with Nanjing Medical University
Peking University First Hospital
The First Affiliated Hospital of Anhui Medical University
The First Affiliated Hospital of Nanchang University
Guangdong Provincial Hospital of Traditional Chinese Medicine
Fudan University
Peking Union Medical College Hospital
The Second Hospital of Hebei Medical University
Peking University Third Hospital
Huashan Hospital
West China Hospital
Qilu Hospital of Shandong University
Second Affiliated Hospital, School of Medicine, Zhejiang University
First Affiliated Hospital of Fujian Medical University
First Affiliated Hospital Xi'an Jiaotong University
The Affiliated Hospital of Qingdao University
Peking University International Hospital
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Shandong Provincial Hospital
The First Affiliated Hospital of Zhengzhou University
Guangdong Provincial People's Hospital
Gansu Provincial Hospital
Zhujiang Hospital
The First Hospital of Jilin University
Henan Provincial People's Hospital
Third Affiliated Hospital, Sun Yat-Sen University
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
First Affiliated Hospital of Jinan University
Tianjin Medical University General Hospital
Zhejiang University
The Second Affiliated Hospital of Chongqing Medical University
Second Affiliated Hospital of Xi'an Jiaotong University
First Hospital of China Medical University
First Affiliated Hospital of Wenzhou Medical University
The First Affiliated Hospital of Shanxi Medical University
First Affiliated Hospital of Xinjiang Medical University
The First Hospital of Hebei Medical University
Sichuan Provincial People's Hospital
Second Affiliated Hospital of Nanchang University
Beijing Haidian Hospital
The Affiliated Hospital of Inner Mongolia Medical University
The First Affiliated Hospital of Dalian Medical University
First Affiliated Hospital of Harbin Medical University
Guangdong Second Provincial General Hospital
Yichang Central People's Hospital
Wuhan Central Hospital
The Second Affiliated Hospital of Kunming Medical University
Linyi People's Hospital
Baotou Central Hospital
Tianjin Huanhu Hospital
Lanzhou University Second Hospital
Seventh Medical Center of PLA Army General Hospital
The Central Hospital of Enshi Tujia And Miao Autonomous Prefecture
The First Affiliated Hospital of Hainan Medical University
The First Affiliated Hospital of USTC (Anhui Provincial Hospital)
Deyang People's Hospital
Army Medical Center of PLA
Nanfang Hospital, Southern Medical University
Jining First People's Hospital
Shanghai Donglei Brain Hospital
Shandong Second Provincial People's Hospital (Shandong Provincial ENT Hospital)
South China Hospital Affiliated to Shenzhen University
The Second Affiliated Hospital of Air Force Medical University (Tangdu Hospital)
Zhongshan Hospital Affiliated to Xiamen University
Jiangsu Province Hospital (Department of Interventional Radiology)
Department of Neurosurgery and Junshan Brain Center, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
The First Affiliated Hospital of Army Medical University (Southwest Hospital)
The First Affiliated Hospital of Air Force Medical University (Xijing Hospital)
Queen Elizabeth Hospital, Hong Kong Special Administrative Region
Ganzhou People's Hospital, Jiangxi Province
Affiliated Hospital of Shandong Second Medical University
Fujian Provincial Hospital Affiliated to Fuzhou University
General Hospital of Eastern Theater Command, Chinese People's Liberation Army
Guangxi Hospital of the First Affiliated Hospital, Sun Yat-sen University
Liaoning Provincial People's Hospital
The Third Medical Center of PLA General Hospital (Former General Hospital of the Chinese People's Armed Police Forces)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 18, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 28, 2030

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 28, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 18, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 18, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 22, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 4, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 2, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • zpmyjsx930826

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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