DRKS00021019招募中1 期
Clinical outcome and Quality of Life of multimodal treatment of arteriovenous malformations of the body - APOLLON - Vascular Malformations
Klinikum der Universität München, Campus Großhadern0 个研究点目标入组 148 人开始时间: 2020年10月8日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 148
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- N/a: Single Arm Study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 5 Years 至 one（—）
- 性别
- All
入选标准
- •Age: > 4 years, < 70 years
- •-Patients with simple peripheral (=extracranial) arteriovenous malformations according to the ISSVA (International Society for the Study of Vascular Anomalies) classification. Each patient and the corresponding diagnosis, is discussed in an interdisciplinary board for vascular anomalies before initiation of treatment.
- •Patients with combined vascular malformations and arteriovenous malformations associated with other anomalies (e. g. Parkes Weber, PTEN hamartoma, HHT) according to the ISSVA (International Society for the Study of Vascular Anomalies) classification
- •-Patients with first line therapy or patients with previous alternative therapies in whom the previous treatments did not lead to durable symptom improvement
- •o Previous surgery or embolization are not an exclusion criterion, but these patients will only be included in case of a therapy-free interval of 12 months
- •-Adults and children will be similarly included
排除标准
- •Patients with AV malformations located in the central nervous system
- •- Patients with AV malformations located in abdominal parenchymal organs and the gastrointestinal tract
- •- Patients with other high-flow vascular anomalies (e. g. vascular tumors) - Patients who have been previously treated by surgery or sclerotherapy/embolization within the last 12 months
- •- Patients with concomitant life-limiting diseases (such as cancer)
- •- Patients with acute inflammatory diseases or acute bacterial superinfection of an AVM related ulceration
- •- Patients with contraindications for invasive treatments
- •o Patients with contrast agent intolerance or renal insufficiency (GFR>30ml/min)
- •o Patients with impaired coagulation status:- Platelet count <50.000 / µl
- •- aPTT > 50s
- •- INR > 1,5
- •o Poor general condition with ECOC performance > 1
- •- Pregnant or breast-feeding women
- •- Inability to access the AVM lesion due to anatomical or pathoanatomical reason
- •- Inability of the patient/parents to understand or follow the study protocol e.g. due to impaired mental health status
- •- Patients/parents who refuse to give informed consent
研究者
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