Dural Arteriovenous Fistulas Research at China INI

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06543472

Enrollment

1180

Registered

2024-08-09

Start date

2001-01-01

Completion date

2024-12-01

Last updated

2026-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fistula

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.

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Inclusion criteria

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

Exclusion criteria

* Non-DAVF lesions confirmed by DSA.

Design outcomes

Primary

Measure	Time frame	Description
Long term prognosis	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.

Secondary

Measure	Time frame	Description
Long-term cure rate	assessed at 3, 6, 12 and 24 months after procedure	The recurrence rate of DAVF after confirmed complete cure, as determined by DSA/MRA/CTA