PHIL Evaluation in the Endovascular Treatment of Intracranial Dural AVF, a European Multi-center, Observational, Prospective, Single Arm and Open Label Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 16
- 主要终点
- Assessment of cure rate and of clinical course of the patient (stable /improvement /deteriorated)
研究概览
简要总结
The primary objective of this study is to demonstrate the safety and efficacy of the PHIL® liquid in endovascular treatment of dural arteriovenous fistula.
详细描述
This is an European multi-center observational study. Treatments and follow-up visits will be done as per standard of care.
The objective of this study is to evaluate the efficacy and safety of the PHIL® device in the treatment of intracranial dural ArterioVenous Fistula (dAVF). The PHIL® device, a non-adhesive liquid embolic agent, has been CE marked since July 2014. It is intended for use in the embolization of lesions in the peripheral and neurovasculature, including arteriovenous malformations and hypervascular tumors.
All patients with an intracranial dAVF that has not been previously treated and will be treated by embolization with PHIL® are eligible for this study. A maximum of 70 patients will be enrolled in this study in 16 European Institutions.
The expected approximate study duration is 38 months.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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 or patient's legally authorized representative has received information about data collection and has signed and dated an Informed Consent Form
- •Patient has an intracranial dAVF that can be treated by embolization with PHIL® used with or without other embolization products except other non-adhesive liquid embolic agents (i.e. Squid, Onyx).
- •Patient is at least 18 years of age.
排除标准
- •Patient has multiple dAVFs to be treated.
- •Patient participates in a study evaluating another medical device, procedure, or medication during the course of dAVF treatment and follow-up per the study protocol.
- •Patient does not give consent to the collection and processing of data required for centralized monitoring
- •Any condition that could prevent patient follow up.
结局指标
主要结局
Assessment of cure rate and of clinical course of the patient (stable /improvement /deteriorated)
时间窗: 3-6 months after last embolization
Cure rate assessment by Angiography
Number of adverse events and assessment of neurological status at 1 month after each embolization
时间窗: 1 month
Neurological assessment by mRS
次要结局
- Number of adverse events and assessment of neurological status(3-6 months after last embolization)
- Improvement in the quality of life of the patient and changes in patients symptoms(3-6 months after last embolization)