NCT06543472

Brief 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. 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,180

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2001

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2001

Completed
23.6 years until next milestone

First Submitted

Initial submission to the registry

August 4, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 9, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

August 19, 2024

Status Verified

July 1, 2024

Enrollment Period

23.8 years

First QC Date

August 4, 2024

Last Update Submit

August 16, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    assessed at 3, 6, 12 and 24 months after procedure

Secondary Outcomes (1)

  • Long-term cure rate

    assessed at 3, 6, 12 and 24 months after procedure

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All are from Chinese individuals.

You may qualify if:

  • Adult patients with DAVFs who were admitted to Xuanwu Hospital.

You may not qualify if:

  • Non-DAVF lesions confirmed by DSA.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xuanwu Hospital, Capital Medical University

Beijing, China

RECRUITING

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Fistula

Condition Hierarchy (Ancestors)

Pathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Hongqi Zhang, MD

    Xuanwu Hospital Department of Neurosurgery

    STUDY CHAIR
  • Xin Su, MD

    Xuanwu Hospital Department of Neurosurgery

    PRINCIPAL INVESTIGATOR
  • Zihao Song, MD

    Xuanwu Hospital Department of Neurosurgery

    PRINCIPAL INVESTIGATOR
  • Huiwei Liu, MD

    Xuanwu Hospital Department of Neurosurgery

    PRINCIPAL INVESTIGATOR
  • Peng Zhang, MD

    Xuanwu Hospital Department of Neurosurgery

    STUDY DIRECTOR
  • Yongjie Ma, MD

    Xuanwu Hospital Department of Neurosurgery

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 4, 2024

First Posted

August 9, 2024

Study Start

January 1, 2001

Primary Completion

October 1, 2024

Study Completion

December 1, 2024

Last Updated

August 19, 2024

Record last verified: 2024-07

Locations