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临床试验/NCT06543472
NCT06543472已完成不适用

Dural Arteriovenous Fistulas Research at China INI

Xuanwu Hospital, Beijing2 个研究点 分布在 1 个国家目标入组 1,180 人开始时间: 2001年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1,180
试验地点
2
主要终点
Long term prognosis

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • Non-DAVF lesions confirmed by DSA.

结局指标

主要结局

Long term prognosis

时间窗: 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.

次要结局

  • Long-term cure rate(assessed at 3, 6, 12 and 24 months after procedure)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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