EASYX-1 : A Multicenter Study on Safety and Efficacy of Easyx Liquid Embolization Agent Used in Five Separate Indications

Study Overview
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Brief Summary
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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).

Official Title
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EASYX-1 : A Multicenter Study on Safety and Efficacy of Easyx Liquid Embolization Agent Used in Five Separate Indications

Conditions
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Varicocele, Endoleak, Portal Vein Thrombosis, Bleeding, Angiomyolipoma

Intervention / Treatment
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* Device: Easyx


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: French multicenter, phase 2b (device), prospective study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Embolization with Easyx<br>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. | Device: Easyx<br>* Embolization will be done with Easyx liquid agent.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety:Total number of per-procedure Serious Adverse Events (SAE) for the safety | Expected and unexpected per-procedure (SAE) related to the EASYX™ use (imputability certain or probable) | one day | 
| Efficacy for type 2 endoleaks embolization | 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). | 6 months | 
| Efficacy for portal vein embolization | 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 | Before ablation | 
| Efficacy for varicocele embolization | 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. | 1 month | 
| Efficacy for angiomyolipoma embolization | 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 | 3 month | 
| Efficacy for active bleeding embolization | 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 | Through embolization completion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SAE | Total number of SAE | up to 6 months | 
| AE | Total number of AE | up to 6 months | 
| untargeted embolization | Total number of untargeted embolization | during procedure | 
| unanticipated ischemia of the target organ | Total number of unanticipated ischemia of the target organ | up to 6 months | 
| orchi-epididymitis | Total number of secondary post-embolization orchi-epididymitis (varicocele embolization) | up to 6 months | 
| neural route lesion | Total number of neural root lesion (type II endoleaks) | up to 6 months | 
| aneurysm rupture | Total number of aneurysm rupture (type II endoleaks) | up to 6 months | 
| tumor rupture | Total number of tumor rupture (angiomyolipoma) | up to 6 months | 
| Survival | Survival rates | 6 months | 
| Pain | Use of Visual Analog Scale (VAS) to evaluate the pain at device injection (between 0: no pain to 10: intolerable pain) | up to 6 months | 
| Pain improvement | Use of Visual Analog Scale (VAS) to evaluate the painful varicocele (between 0: no pain to 10: intolerable pain) | up to 6 months | 
| unanticipated use of another liquid agent | Total number of unanticipated use of another liquid agent for embolization | during procedure | 
| technical success | Total number of procedures with immediate technical success | end of the procedure | 
| Easyx volume | Mean volume of EASYX™ used during the index procedure | during procedure | 
| Occlusion | Mean degree of occlusion of the target vessel(s) | during procedure | 
| Re-intervention | Total number of re-intervention for study procedure | up to 6 months | 
| Interventional Radiologist (IR) satisfaction | Immediate technical satisfaction questionnaire (as perceived by the Interventional Radiologist) | end of the procedure | 
| Clinical efficacy | Total number of embolization clinical efficacy | up to 6 months | 
| Other liquid embolics | Total number of procedures with a need to complete with another liquid embolic to achieve optimal result | end of the procedure | 
| Quality of life | Patient's quality of life (EQ-5D) | up to 6 months | 
| Imaging | Technical success at follow-up assessed on CT-scan for type II endoleaks defined as the ability for the physician to give a diagnosis (absence or minor artifacts) on imaging | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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liquid embolics