A Randomized Trial of Unruptured Brain Arteriovenous Malformations
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 226
- 试验地点
- 126
- 主要终点
- Difference of 5-year event rates between two arms
研究概览
简要总结
The purpose of this study is to determine if medical management is better than invasive therapy for improving the long-term outcome of patients with unruptured brain arteriovenous malformations.
详细描述
Brain arteriovenous malformations (BAVMs) are an infrequent but important cause of stroke, particularly in a young population. Current invasive treatment strategies are varied and include endovascular procedures, neurosurgery, and radiotherapy. All of these treatments are administered on the assumption that they can be achieved at acceptably minor complication rates, decrease the risk of subsequent hemorrhage, and lead to better long-term outcomes.
Recent data from the literature comparing initial presentation and outcome for patients with ruptured and unruptured BAVMs have raised the possibility that such elective invasive treatment for unruptured BAVMs may yield worse outcomes than managing patients symptomatically with therapy. Unfortunately, no controlled clinical trials have yet been undertaken for management of unruptured BAVMs to address these concerns. Therefore, the goal of this randomized controlled trial is to determine if the long-term outcomes of patients who receive medical management for symptoms (e.g., headache, seizures) associated with an unruptured BAVM are superior to those who receive medical management and invasive therapy to eradicate the BAVM.
Participants will be randomly assigned to receive either symptomatic medical management alone or such management with invasive therapies (any combination of surgery, endovascular embolization, or radiotherapy). Functional assessment will be carried out at the time of randomization, pre-intervention and 48-hour post-intervention, and for all participants at 1 month, and at 6 month intervals throughout the follow up period which will be a minimum of 5 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient must have unruptured BAVM diagnosed by MRI/MRA, CTA and/or angiogram
- •Patient must be 18 years of age or older
- •Patient must have signed Informed Consent, Release of Medical Information, and Health Insurance Portability and Accountability Act (HIPAA/U.S. only) Forms
排除标准
- •Patient has BAVM presenting with evidence of recent or prior hemorrhage
- •Patient has received prior BAVM therapy (endovascular, surgical, radiotherapy)
- •Patient has BAVM deemed untreatable by local team, or has concomitant vascular or brain disease that interferes with/or contraindicates any interventional therapy type (stenosis/occlusion of neck artery, prior brain surgery/radiation for other reasons)
- •Patient has baseline Rankin ≥2
- •Patient has concomitant disease reducing life expectancy to less than 10 years
- •Patient has thrombocytopenia (< 100,000/μL),
- •Patient has uncorrectable coagulopathy (INR>1.5)
- •Patient is pregnant or lactating
- •Patient has known allergy against iodine contrast agents
- •Patient has multiple-foci BAVMs
- •Patient has any form of arteriovenous or spinal fistulas
- •Previous diagnosis of any of the following -
- •Patient has a diagnosed Vein of Galen type malformation
- •Patient has a diagnosed cavernous malformation
- •Patient has a diagnosed dural arteriovenous fistula
- •Patient has a diagnosed venous malformation
- •Patient has a diagnosed neurocutaneous syndrome such as cerebro-retinal angiomatosis (von Hippel-Lindau), encephalo-trigeminal syndrome (Sturge-Weber), or Wyburn-Mason syndrome
- •Patient has diagnosed BAVMs in context of moya-moya-type changes
- •Patient has diagnosed hereditary hemorrhagic telangiectasia (Rendu-Osler-Weber)
结局指标
主要结局
Difference of 5-year event rates between two arms
时间窗: 5 years
The hypothesis to be tested is that there is no difference between medical management and interventional therapy in the time to stroke or death from any cause.
次要结局
- Prevalence of the risk of death or clinical impairment at 5 years post-randomization with early intervention(5 years)
研究者
Jay Preston Mohr
Daniel Sciarra Professor of Neurology
Columbia University