FistulaNCT06543472
Dural Arteriovenous Fistulas Research at China INI
An observational study of Fistula, run by Xuanwu Hospital, Beijing at 1 site in China.
Trial summary
Dural arteriovenous fistula (DAVF) refers to abnormal connections between meningeal arteries and dural venous sinuses and/or subarachnoid veins. DAVF accounts for approximately 10% to 15% of intracranial vascular malformations. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Fistula
- How many people
- 1,180 participants
- Where
- 1 siteChina
- Study dates
- Jan 2001to Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 80 years
- All sexes
- Adult, Older adult
Study population: All are from Chinese individuals.
Who may be able to join
- Adult patients with DAVFs who were admitted to Xuanwu Hospital.
Who cannot join
- Non-DAVF lesions confirmed by DSA.
Trial locations and contacts
1 site in 1 country.
About this study
Dural arteriovenous fistula (DAVF) refers to abnormal connections between meningeal arteries and dural venous sinuses and/or subarachnoid veins. DAVF accounts for approximately 10% to 15% of intracranial vascular malformations. With advancements in imaging technology, increased awareness among physicians, and an aging population, the incidence of DAVF appears to be on the rise. Some literature even suggests it may surpass the occurrence of arteriovenous malformations. Several large-scale retrospective studies have been conducted internationally, involving over 1,000 cases, but some of their findings differ from what is commonly understood. Currently, there is a lack of large-sample single-center studies on DAVF, highlighting the urgent need for such research.
Read the detailed description
Title：Dural Arteriovenous Fistulas Research at China INI.
Purpose：The incidence of DAVF is low. By collecting clinical data, we aim to establish a comprehensive database and biobank. This will help us elucidate the potential pathogenesis, vascular architecture, biological markers, and treatment outcomes of DAVFs. Furthermore, this study aims to address current controversies (such as treatment strategies for DAVF with pial arterial supply), unresolved issues (such as the optimal treatment and prognosis of infantile type DAVF), and further explore possible mechanisms of DAVF development.
- Conditions
- Fistula
- Medical subject headings
- Fistula
What is being measured
The primary outcome is the main question the study is designed to answer.
Long term prognosis
Safety endpoints include perioperative and postoperative complications, as well as the clinical status of the patients. This is evaluated using the preoperative modified Rankin Scale (mRS), mRS at discharge, and mRS at 6 to 12 months, along with the most recent clinical (inpatient/outpatient) or telephone follow-up. Efficacy endpoints include the immediate DAVF occlusion status after the last treatment, and the results from imaging follow-ups (DSA/MRA/CTA) at 6 to 12 months and the latest follow-up.
Measured: assessed at 3, 6, 12 and 24 months after procedure
Secondary outcomes (1)
Long-term cure rate
The recurrence rate of DAVF after confirmed complete cure, as determined by DSA/MRA/CTA
Measured: assessed at 3, 6, 12 and 24 months after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study startJan 2001
- Primary completionOct 2024
- Study completionDec 2024
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 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
- Retrospective
- Enrolment
- 1,180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hongqi Zhang, MD, Study chair, Xuanwu Hospital Department of NeurosurgeryXin Su, MD, Principal investigator, Xuanwu Hospital Department of NeurosurgeryZihao Song, MD, Principal investigator, Xuanwu Hospital Department of NeurosurgeryHuiwei Liu, MD, Principal investigator, Xuanwu Hospital Department of NeurosurgeryPeng Zhang, MD, Study director, Xuanwu Hospital Department of NeurosurgeryYongjie Ma, MD, Study director, Xuanwu Hospital Department of Neurosurgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06543472
- Sponsor's protocol ID
- XW0630
- Status last verified
- May 2026
- First submitted
- 4 Aug 2024
- Last updated
- 22 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Su X, Li X, Song Z, Chen Y, Huang M, Liu H, Pang H, Zhang C, Sun L, Ye M, Hong T, Ma Y, Zhang H, Zhang P. Tentorial Dural Arteriovenous Fistulas: A Retrospective Cohort Study. Oper Neurosurg. 2025 Nov 1;29(5):678-685. doi: 10.1227/ons.0000000000001524. Epub 2025 Mar 5.
PubMed 40042314
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dural Arteriovenous Fistulas Research at China INI
- ClinicalTrials.gov ID
- NCT06543472
- Acronym / sponsor ID
- XW0630
- Conditions
- Fistula
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,180 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Study start
- Jan 2001 (actual)
- Primary completion
- Oct 2024 (actual)
- Study completion
- Dec 2024 (actual)
- First posted
- 9 Aug 2024 (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.
Dural arteriovenous fistula (DAVF) refers to abnormal connections between meningeal arteries and dural venous sinuses and/or subarachnoid veins. DAVF accounts for approximately 10% to 15% of intracranial vascular malformations. With advancements in imaging technology, increased awareness among physicians, and an aging population, the incidence of DAVF appears to be on the rise. Some literature even suggests it may surpass the occurrence of arteriovenous malformations. Several large-scale retrospective studies have been conducted internationally, involving over 1,000 cases, but some of their findings differ from what is commonly understood. Currently, there is a lack of large-sample single-center studies on DAVF, highlighting the urgent need for such research.
Detailed description
Title：Dural Arteriovenous Fistulas Research at China INI.
Purpose：The incidence of DAVF is low. By collecting clinical data, we aim to establish a comprehensive database and biobank. This will help us elucidate the potential pathogenesis, vascular architecture, biological markers, and treatment outcomes of DAVFs. Furthermore, this study aims to address current controversies (such as treatment strategies for DAVF with pial arterial supply), unresolved issues (such as the optimal treatment and prognosis of infantile type DAVF), and further explore possible mechanisms of DAVF development.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All are from Chinese individuals.
Key inclusion criteria (1 listed)
- Adult patients with DAVFs who were admitted to Xuanwu Hospital.
Key exclusion criteria (1 listed)
- Non-DAVF lesions confirmed by DSA.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Long term prognosis
Time frame: assessed at 3, 6, 12 and 24 months after procedure
Safety endpoints include perioperative and postoperative complications, as well as the clinical status of the patients. This is evaluated using the preoperative modified Rankin Scale (mRS), mRS at discharge, and mRS at 6 to 12 months, along with the most recent clinical (inpatient/outpatient) or telephone follow-up. Efficacy endpoints include the immediate DAVF occlusion status after the last treatment, and the results from imaging follow-ups (DSA/MRA/CTA) at 6 to 12 months and the latest follow-up.
1 secondary outcome
Long-term cure rate
Time frame: assessed at 3, 6, 12 and 24 months after procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Derived from this study: PubMed 40042314Su X, Li X, Song Z, Chen Y, Huang M, Liu H, Pang H, Zhang C, Sun L, Ye M, Hong T, Ma Y, Zhang H, Zhang P. Tentorial Dural Arteriovenous Fistulas: A Retrospective Cohort Study. Oper Neurosurg. 2025 Nov 1;29(5):678-685. doi: 10.1227/ons.0000000000001524. Epub 2025 Mar 5.
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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. This study is not recruiting at the moment.
Hongqi Zhang, MD study chair
Xuanwu Hospital Department of Neurosurgery
Xin Su, MD principal investigator
Xuanwu Hospital Department of Neurosurgery
Zihao Song, MD principal investigator
Xuanwu Hospital Department of Neurosurgery
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 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 22 May 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Long term prognosis (time frame: assessed at 3, 6, 12 and 24 months after procedure). 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 NCT06543472, 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 22 May 2026.