ISRCTN44013133已完成未知
A Randomised trial of Unruptured Brain Arteriovenous malformations
IH - National Institute of Neurological Disorders and Stroke (USA)0 个研究点目标入组 226 人开始时间: 2006年9月11日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 226
研究概览
简要总结
2010 protocol in http://www.ncbi.nlm.nih.gov/pubmed/19953376 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/24268105 2020 5-year follow-up results in https://pubmed.ncbi.nlm.nih.gov/32562682/ (added 22/06/2020)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Patient must have unruptured BAVM diagnosed by Magnetic Resonance Imaging (MRI), Magnetic Resonance Angiography (MRA) and/or angiogram
- •2. Patient must be 18 years of age or older
- •3. Patient must have signed informed consent
排除标准
- •1. Patient has BAVM presenting with evidence of recent or prior hemorrhage
- •2. Patient has received prior BAVM therapy (endovascular, surgical, radiotherapy)
- •3. Patient has BAVM deemed untreatable by local team, or has concomitant vascular or brain disease that interferes with/or contraindicts any invasive therapy type (stenosis/occlusion of neck artery, prior brain surgery/radiation for other reasons)
- •4. Patient has baseline Rankin more than or equal to two
- •5. Patient has concomitant disease reducing life expectancy to less than ten years
- •6. Patient has thrombocytopenia (less than 100,000/nl)
- •7. Patient has coagulopathy (spontaneous or iatrogenic Inernational Normalised Ratio(INR) more than 1.5, Prothrombin Time (PT) more than 30)
- •8. Patient is pregnant, lactating, or plans to become pregnant
- •9. Patient has known allergy against iodine contrast agents
- •10. Patient has multiple-foci BAVMs
- •11. Patient has any form of arteriovenous or spinal fistulas
- •12. Patient has a diagnosed Vein of Galen type malformation
- •13. Patient has a diagnosed cavernous malformation
- •14. Patient has a diagnosed dural arteriovenous fistula
- •15. Patient has a diagnosed venous malformation
- •16. Patient has a diagnosed neurocutaneous syndrome such as cerebro-retinal angiomatosis (von Hippel-Lindau), encephalo-trigeminal syndrome (Sturge-Weber), or Wyburn-Mason syndrome
- •17. Patient has diagnosed BAVMs in context of moya-moya-type changes
- •18. Patient has diagnosed hereditary hemorrhagic telangiectasia (Rendu-Osler-Weber)
研究者
相似试验
已完成
3 期
A Randomized Trial of Unruptured Brain AVMsArteriovenous Malformations, CerebralNCT00389181Columbia University226
已完成
不适用
A randomised, double-blind, placebo-controlled trial assessing the safety and efficacy of intracoronary NITRITE infusion during Acute Myocardial InfarctioTopic: CardiovascularSubtopic: Cardiovascular (all Subtopics)Disease: AtherothrombosisCirculatory SystemAcute myocardial infarctionISRCTN38736987Barts and The London NHS Trust (UK)80
已完成
不适用
Efficacy of an educational school-based intervention to reduce prevalence of obesity in childhood in CataloniaObesityISRCTN29247645niversity of Rovira i Virgili (Universitat Rovira i Virgili) (Spain)1,400
Unknown
不适用
New Therapeutic System of Unruptured Intracranial Aneurysms Based on Big Data From Chinese PopulationUnruptured Cerebral AneurysmTreatment StrategyNCT03153865Changhai Hospital2,000
已完成
不适用
Space - for physical activityPhysical activity and physical fitnessPhysical activityISRCTN79122411Trygfonden (Denmark)1,348