Dural Arteriovenous Fistulas Research at China INI

Recruiting

• Conditions: Fistula

• Registration Number: NCT06543472
• Lead Sponsor: Xuanwu Hospital, Beijing

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.

Study Timeline

• Study Start: 2001-01
• Status Verified: 2024-07
• Study First Submitted: 2024-08-04
• Study First Submitted QC: 2024-08-06
• Study First Posted: 2024-08-09
• Last Update Submitted: 2024-08-16
• Last Update Posted: 2024-08-19
• Primary Completion: 2024-10
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1180

Inclusion Criteria

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

Exclusion Criteria

• Non-DAVF lesions confirmed by DSA.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Xuanwu Hospital, Capital Medical University; 🇨🇳 Beijing, China