Intracranial Dural Arteriovenous FistulaDREAMNCT07604688
Multicenter Registry Study of Patients With Intracranial Dural Arteriovenous Fistulas in China
An observational study of Intracranial Dural Arteriovenous Fistula, run by Xuanwu Hospital, Beijing at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intracranial Dural Arteriovenous Fistula
- What is being tested?
- endovascular
- Type of treatment
- Surgery or procedure
- How many people
- 10,050 participants
- Where
- 1 siteChina
- Study dates
- 18 May 2026to 28 Feb 2030
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Yongjie Ma, M.D contact
China1 site, 1 recruiting
- Recruiting
Xuanwu Hospital
Beijing, 100053
Peng Zhang, 86-13911029232, 1258940078@qq.com
About this study
Official title: 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.
- Conditions
- Intracranial Dural Arteriovenous Fistula
- Being tested
- endovascular
- Keywords
- intracranial dural arteriovenous fistula, fistula, malforamtion, outcome
- Medical subject headings
- Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endovascularProcedure or surgery
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months after treatment
Secondary outcomes (2)
Angiographic obliteration and recurrence rates at 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.
Measured: 6 months after treatment
Improvement in modified Rankin Scale (mRS) score at 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.
Measured: 12 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
- Study start18 May 2026 (estimated)
- Primary completion28 Feb 2030 (estimated)
- Study completion28 Feb 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intracranial Dural Arteriovenous FistulaStudies of the same condition, open and under way.
- More trials run by Xuanwu Hospital, BeijingThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10,050 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- 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, Southwest Hospital, China, Gansu Provincial Hospital, The First Affiliated Hospital of Air Force Medical 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, The 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
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07604688
- Sponsor's protocol ID
- zpmyjsx930826
- Acronym
- DREAM
- Status last verified
- Jun 2026
- First submitted
- 18 May 2026
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 39922696
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dural Arteriovenous Fistulas Registry, Evaluation, and Management Study in China (DREAM)
- ClinicalTrials.gov ID
- NCT07604688
- Acronym / sponsor ID
- DREAM / zpmyjsx930826
- Conditions
- Intracranial Dural Arteriovenous Fistula
- Keywords
- intracranial dural arteriovenous fistula, fistula, malforamtion, outcome
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10,050 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- 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, Southwest Hospital, China, Gansu Provincial Hospital, The First Affiliated Hospital of Air Force Medical 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, The 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
- Study start
- 18 May 2026 (estimated)
- Primary completion
- 28 Feb 2030 (estimated)
- Study completion
- 28 Feb 2030 (estimated)
- First posted
- 22 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| endovascularThis 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. | Procedure or surgery | – |
Primary outcome
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.
2 secondary outcomes
Angiographic obliteration and recurrence rates at 6 months after treatment
Time frame: 6 months after treatment
Improvement in modified Rankin Scale (mRS) score at 12 months after treatment
Time frame: 12 months after treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
- Results publication: PubMed 39922696Su 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yongjie Ma, M.D contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intracranial Dural Arteriovenous Fistula, run by Xuanwu Hospital, Beijing at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xin Su, M.D (86-18210685023, 1258940078@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in modified Rankin Scale (mRS) score at 6 months after treatment (time frame: 6 months after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07604688, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.