Jin Hengwei, Huo Xiaochuan, Jiang Yuhua, Li Xiaolong, Li Youxiang
Department of Interventional Neuroradiology, Beijing Neurosurgical Institute and Beijing Tiantan Hospital, Capital Medical University, No.6, Tiantan Xili, Dongcheng, 100050, Beijing, China.
Beijing Engineering Research Center for Interventional Neuroradiology, China.
Contemp Clin Trials Commun. 2017 Jun 22;7:103-108. doi: 10.1016/j.conctc.2017.06.006. eCollection 2017 Sep.
Brain arteriovenous malformations (BAVMs) are associated with high morbidity and mortality. The treatment of BAVM remains controversial. Microinvasive treatment, including endovascular therapy and gamma knife surgery, has been the first choice in many conditions. However, the overall clinical outcome of microinvasive treatment remains unknown and a prospective trial is needed.
This is a prospective, non-randomized, and multicenter observational registry clinical trial to evaluate the safety and efficacy of microinvasive treatment for BAVMs. The study will require up to 400 patients in approximately 12 or more centers in China, followed for 2 years. Main subjects of this study are BAVM patients underwent endovascular therapy and/or gamma knife surgery. The trial will not affect the choice of treatment modality. The primary outcomes are perioperative complications (safety), and postoperative hemorrhage incidence rate and complete occlusion rate (efficacy). Secondary outcomes are elimination of hemorrhage risk factors (coexisting aneurysms and arteriovenous fistula), volume reduction and remission of symptoms. Safety and efficacy of endovascular therapy, gamma knife surgery, and various combination modes of the two modalities will be compared. Operative complications and outcomes at pretreatment, post-treatment, at discharge and at 3 months, 6 months and 2 years follow-up intervals will be analyzed using the modified Rankin Scale (mRS).
The most confusion on BAVM treatment is whether to choose interventional therapy or medical therapy, and the choice of interventional therapy modes. This study will provide evidence for evaluating the safety and efficacy of microinvasive treatment in China, to characterize the microinvasive treatment strategy for BAVMs.
脑动静脉畸形（BAVM）与高发病率和死亡率相关。BAVM的治疗仍存在争议。微创治疗，包括血管内治疗和伽玛刀手术，在许多情况下已成为首选。然而，微创治疗的总体临床结果尚不清楚，需要进行一项前瞻性试验。
这是一项前瞻性、非随机、多中心观察性注册临床试验，旨在评估BAVM微创治疗的安全性和有效性。该研究将在中国约12个或更多中心招募多达400名患者，随访2年。本研究的主要对象是接受血管内治疗和/或伽玛刀手术的BAVM患者。该试验不会影响治疗方式的选择。主要结局指标是围手术期并发症（安全性）、术后出血发生率和完全闭塞率（有效性）。次要结局指标是出血危险因素（并存动脉瘤和动静脉瘘）的消除、体积缩小和症状缓解。将比较血管内治疗、伽玛刀手术以及两种方式的各种联合模式的安全性和有效性。将使用改良Rankin量表（mRS）分析术前、术后、出院时以及3个月、6个月和2年随访间隔的手术并发症和结局。
BAVM治疗中最令人困惑的是选择介入治疗还是药物治疗，以及介入治疗模式的选择。本研究将为评估中国微创治疗的安全性和有效性提供证据，以明确BAVM的微创治疗策略。
