An interventional study of Easyx in Varicocele, Endoleak and Portal Vein Thrombosis, sponsored by Assistance Publique - Hôpitaux de Paris. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-10-09.
Sponsored by Assistance Publique - Hôpitaux de Paris · Not applicable, Interventional, and Treatment
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).
Exclusion Criteria:
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
Embolization will be done with Easyx liquid agent.
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")
Time frame: 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).
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: Through embolization completion
SAE
Total number of SAE
Time frame: up to 6 months
AE
Total number of AE
Time frame: up to 6 months
untargeted embolization
Total number of untargeted embolization
Time frame: during procedure
unanticipated ischemia of the target organ
Total number of unanticipated ischemia of the target organ
Time frame: up to 6 months
orchi-epididymitis
Total number of secondary post-embolization orchi-epididymitis (varicocele embolization)
Time frame: up to 6 months
neural route lesion
Total number of neural root lesion (type II endoleaks)
Time frame: up to 6 months
aneurysm rupture
Total number of aneurysm rupture (type II endoleaks)
Time frame: up to 6 months
tumor rupture
Total number of tumor rupture (angiomyolipoma)
Time frame: up to 6 months
Survival
Survival rates
Time frame: 6 months
Pain
Use of Visual Analog Scale (VAS) to evaluate the pain at device injection (between 0: no pain to 10: intolerable pain)
Time frame: 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)
Time frame: up to 6 months
unanticipated use of another liquid agent
Total number of unanticipated use of another liquid agent for embolization
Time frame: during procedure
technical success
Total number of procedures with immediate technical success
Time frame: end of the procedure
Easyx volume
Mean volume of EASYX™ used during the index procedure
Time frame: during procedure
Occlusion
Mean degree of occlusion of the target vessel(s)
Time frame: during procedure
Re-intervention
Total number of re-intervention for study procedure
Time frame: up to 6 months
Interventional Radiologist (IR) satisfaction
Immediate technical satisfaction questionnaire (as perceived by the Interventional Radiologist)
Time frame: end of the procedure
Clinical efficacy
Total number of embolization clinical efficacy
Time frame: up to 6 months
Other liquid embolics
Total number of procedures with a need to complete with another liquid embolic to achieve optimal result
Time frame: end of the procedure
Quality of life
Patient's quality of life (EQ-5D)
Time frame: 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
Time frame: 6 months
Plan to share: No
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Angiomyolipoma
Assistance Publique - Hôpitaux de Paris