Prospective, Multicenter, Multinational Study to Assess the Safety and Performance of the Easyx Antia Liquid Embolic in Intracranial Interventions IDEALE Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 65
- 主要终点
- Device related adverse events
研究概览
简要总结
The study is a prospective, multicenter, multinational study to assess the safety and performance of the Easyx (trade name) Antia Liquid Embolic during embolization of intracranial malformations and fistulas. The clinical trial will include patients already scheduled for neuroradiological interventions. It is estimated that up to 8 sites will be required to collect the safety and performance data of the study material. Up to 65 patients will be enrolled in the study to achieve 53 evaluable patients. Each study centre will be required to treat 5 patients with a Dural arteriovenous fistula - DAVF before they can treat brain arteriovenous malformations - AVMs or brain tumours. Only experienced neuroradiologists will be invited to participate in this study.
详细描述
Study Procedures Once the subject has agreed to participate in the study and has signed the consent form, the baseline visit can be performed. A full medical history will be taken and a physical exam will be done as per local routine practice for an embolization procedure. The Cognard scale will be performed to assess the grade of a DAVF and the Spetzler Martin grade will be assessed if a brain AVM is to be treated; these are standard scoring systems for brain DAVFs and AVMs. A neurological exam will be done and any abnormalities will be documented.
Procedure Embolization of the DAVF or BAVM or tumor will be done as per routine practice but using the Easyx product. The procedure to treat a BAVM or a tumor may be staged and complex DAVFs may require a second treatment to fully occlude the fistula. The plan for treatment will be noted at the procedure visit and subsequent planned interventions will not be classed as adverse events. All interventions up to the 12 month follow up visit will be recorded in the Case Report Forms - CRFs. If the preliminary angiogram immediately prior to treatment shows that the target area can no longer be treated with an embolic product, the patient will be withdrawn from the study at this point and alternative treatment as per routine practice will be planned. Procedure details will be noted and feedback from the treating interventionalist will be collected, to determine the ease of handling of the product.
If the DAVF occlusion is complete, an assessment of where occlusion has been performed will be noted. If the DAVF or BAVM occlusion or blockage of the supply to a tumor is incomplete, the reason for incomplete occlusion will be given. The subject will be asked to complete a visual analog scale immediately after the procedure to report on any pain. A neurological exam will be done post treatment to assess for any changes.
Discharge The subject's condition will be recorded at discharge. Adverse events will be reported as well as any subsequent imaging or interventions that occurred following the initial treatment. A neurological exam will be done and any changes will be recorded. The Rankin score will only be done if there has been a hemorrhagic or ischemic stroke; this is a well known stroke scale.
One Month Follow up A follow up visit will be done at the clinic one month after the initial treatment. Adverse events will be reported and any subsequent imaging or interventions that occurred following the initial treatment. A neurological exam will be done and any changes will be recorded. The Rankin score will only be done if there has been a hemorrhagic or ischemic stroke.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Subject is aged 18 years or over
- •Subject exhibits a DAVF or BAVM or tumor that has been selected for endovascular treatment
- •Subject has provided written consent for the procedure.
- •Subject agrees to all follow up visits required by the protocol
- •The Subject is clinically and neurologically stable for a minimum of 48 hours prior to embolization.
排除标准
- •The subject has a brain AVM with high flow arteriovenous fistula that the investigator has determined to be unsuitable for embolization.
- •The subject has had acute cerebral bleeding within the last 6 months.
- •The patient is participating in another research study involving another investigational device, procedure or drug.
- •The brain AVM or DAVF or tumor has been previously treated with another embolization agent.
- •The subject has a bleeding disorder.
- •The subject is female and has a positive pregnancy test.
- •The subject has a life expectancy of less than 1 year.
- •Subject has a known allergy to contrast media used for radiography.
- •Subject has a known allergy to Dimethyl Sulfoxide - DMSO (solvent for the embolic product).
- •Subject has a condition that would prevent them attending follow up visits for up to 1 year.
结局指标
主要结局
Device related adverse events
时间窗: 1 month
The incidence of adverse events related to the device and procedure at 1 month follow up to ensure that the rate is equivalent to other products already on the market.
Technical Success
时间窗: immediate
The primary technical success endpoint is measured by evaluating the percentage achieved obliteration degree of the DAVF vascular lesion target or planned AVM region or vascular supply to a tumor. The assessment is done by means of a questionnaire
次要结局
- Neurological changes(1, 6 and12 months)
- Status of the lesion(3 and 6 months)
- Useability(immediate)