EASYX-1 : A Multicenter Study on Safety and Efficacy of Easyx Liquid Embolization Agent Used in Five Separate Indications
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Safety:Total number of per-procedure Serious Adverse Events (SAE) for the safety
研究概览
简要总结
The EASYX™ Liquid Embolic is a new injectable, precipitating polymeric agent for the obliteration of vascular spaces through direct puncture or catheter access performed under X-ray guidance. The embolic liquid is an iodinized Polyvinyl Alcohol (PVA) Polymer ether. Iodine groups are covalently grafted to the PVA polymer backbone, whereby a stable nondegradable polymer with the desired features is created. The resulting polymer is dissolved in Dimethyl Sulfoxide (DMSO). EASYX™ is CE-marked since December 2016 and has been used in humans a few time for type II endoleaks, portal vein and varicocele (<10 cases at the date of submission). The purpose of this study is to evaluate the safety and efficacy of EASYX™ embolization liquid for the percutaneous treatment of vascular lesions, i.e. embolization of varicocele, type II endoleaks, portal vein before surgery, active peripheral bleeding or angiomyolipoma (AML).
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
- •Patient presenting with indication of varicocele, type II endoleaks, portal vein, AML or active embolization with a liquid agent
- •Aged ≥ 18 years
- •Affiliated to a French health insurance system
排除标准
- •Hypersensitivity to Polyvinyl Alcohol (PVA) Polymer
- •Hypersensitivity to DMSO solvent
- •Patient unable or unwilling to provide a written informed consent
- •Patient participating in another interventional study
- •Pregnant or breastfeeding woman
- •Prisoners
研究组 & 干预措施
Embolization with Easyx
Patients requiring embolization of varicocele, portal vein before ablation, type 2 endoleak, angiomyolipoma or active bleeding will be treated with the liquid embolic agent Easyx during index procedure.
干预措施: Easyx (Device)
结局指标
主要结局
Safety:Total number of per-procedure Serious Adverse Events (SAE) for the safety
时间窗: one day
Expected and unexpected per-procedure (SAE) related to the EASYX™ use (imputability "certain" or "probable")
Efficacy for type 2 endoleaks embolization
时间窗: 6 months
Percentage of clinical success. The clinical success of type II endoleaks embolization is defined as the stability or reduction of aneurysm's both anterioposterior and transverse diameters assessed on CT-scan at 6 months compared to baseline (4mm threshold).
Efficacy for varicocele embolization
时间窗: 1 month
Percentage of clinical success for varicocele embolization The clinical success of varicocele embolization is defined as the absence of reflux on ultrasound Doppler at one month follow-up.
Efficacy for active bleeding embolization
时间窗: Through embolization completion
Percentage of clinical success for active bleeding embolization The clinical success of active bleeding embolization is defined as the complete occlusion of the target vessel assessed by angiography during the index procedure
Efficacy for portal vein embolization
时间窗: Before ablation
Percentage of clinical success before ablation for portal vein embolization. The clinical success of portal vein embolization is defined as the growth ≥15 % of the remnant liver assessed on presurgical CT-scan compared to baseline
Efficacy for angiomyolipoma embolization
时间窗: 3 month
Percentage of clinical success for angiomyolipoma embolization. The clinical success of angiomyolipoma embolization is defined as the reduction \>10% of at least one diameter on MRI or CT-scan at 3 months follow-up compared to baseline
次要结局
- SAE(up to 6 months)
- Survival(6 months)
- unanticipated use of another liquid agent(during procedure)
- Imaging(6 months)
- orchi-epididymitis(up to 6 months)
- Pain(up to 6 months)
- Pain improvement(up to 6 months)
- Re-intervention(up to 6 months)
- Clinical efficacy(up to 6 months)
- Other liquid embolics(end of the procedure)
- AE(up to 6 months)
- Easyx volume(during procedure)
- untargeted embolization(during procedure)
- unanticipated ischemia of the target organ(up to 6 months)
- aneurysm rupture(up to 6 months)
- Occlusion(during procedure)
- Quality of life(up to 6 months)
- neural route lesion(up to 6 months)
- tumor rupture(up to 6 months)
- technical success(end of the procedure)
- Interventional Radiologist (IR) satisfaction(end of the procedure)